Ways To Enhance Your Penis Functioning
When you look for penis expansion on the World Wide Web you are bedeviled into a barrageof pills, physical exercises, pumps and extenders but you've no mind how to assort the wheat from the chaff. I have tried them altogether and most of them broke down. But it just takes one way that acts to expand your penis and I discovered that formula...
Tablets are the finest for physiologically altering your penis and how it functions. I cognize this as tablets made me experience aroused. But the matter that I attempted most of all, penis enlargement, was not upcoming through the apply of penis tablets. Perhaps there are several which act, but I for sure did not find them.
Fallouts from applying penis improvement goods are varied. You could convert impotent, you could experience urinary self-gratification, burst blood vessels, explosion chambers in the penis, scar tissue and many others...
The issue with pumps and extenders is that they could break your penis, leaving it un-needed for any sort of sexual practice. Physical exercises provide a false feeling of security as the thing you apply to expand your penis is your hand. But do not be duped. This could have the same damaging consequences as the above.
Natural formulas apply science to assist enlarging your member. As the penis matured by nature without help during puberty, it can mature again. It's barely a condition of having the right biochemistry to advance development. If you've the right foods flowing through your blood-stream then penis development is a natural by-product.
Tablets are the finest for physiologically altering your penis and how it functions. I cognize this as tablets made me experience aroused. But the matter that I attempted most of all, penis enlargement, was not upcoming through the apply of penis tablets. Perhaps there are several which act, but I for sure did not find them.
Fallouts from applying penis improvement goods are varied. You could convert impotent, you could experience urinary self-gratification, burst blood vessels, explosion chambers in the penis, scar tissue and many others...
The issue with pumps and extenders is that they could break your penis, leaving it un-needed for any sort of sexual practice. Physical exercises provide a false feeling of security as the thing you apply to expand your penis is your hand. But do not be duped. This could have the same damaging consequences as the above.
Natural formulas apply science to assist enlarging your member. As the penis matured by nature without help during puberty, it can mature again. It's barely a condition of having the right biochemistry to advance development. If you've the right foods flowing through your blood-stream then penis development is a natural by-product.
Cialis(R)(tadalafil) Effective In Treating Erectile Dysfunction Caused By Traumatic Spinal Cord Injury, New Data Shows
Data presented today at the 21st Congress of the European Association of Urology (EAU) show that when patients who had erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI) were treated with Cialis(R) (tadalafil)(1) (N=140), their International Index of Erectile Function (IIEF) Erectile Function (EF) Domain(2) scores improved from a mean baseline score of 13.5 to a score of 22.6 at endpoint. This is compared with placebo treated patients (N=44) with a mean baseline score of 13.0 and a score of 13.6 at endpoint. It is generally considered that an improvement of 4.0 points or more in the IIEF domain score reflects a clinically meaningful change.(3) Further, 54 percent of SCI patients treated with Cialis reported "normal" erectile function at the end of the treatment phase, as measured by the IIEF EF (IIEF EF domain score greater than or equal to 26).(4)
Study Analysis and Results
The efficacy of Cialis in patients with SCI was assessed by their scores on the IIEF EF domain, responses to the Sexual Encounter Profile (SEP)(5) diary question two (successful penetration) and question three (successful intercourse), and the Global Assessment Questionnaire(6) (GAQ) question one (improved erections). Tolerability was evaluated using treatment-emergent adverse events and vital signs collected at each assessment phase in the trial.
According to SEP diary question two(7), on average, patients receiving Cialis (N=139) reported the ability to penetrate their partner in 75.4 percent of attempts (43.6 percent at baseline). In patients receiving placebo (N=42), successful penetration was reported, on average, in 41.1 percent of attempts (44.9 percent at baseline). For SEP diary question three(8), on average, patients receiving Cialis (N=139) reported successful intercourse in 47.6 percent of attempts (10.8 percent at baseline). For patients receiving placebo (N=42), successful intercourse was reported, on average, in 16.8 percent of attempts (8.6 percent at baseline). For those patients receiving Cialis, the SEP diary questions two and three post-baseline scores were significantly different (p < 0.001) versus placebo.
According to GAQ question one (improved erections), 84.6 percent of patients (N=115) in the study reported improved erections after treatment with Cialis, whereas 19.5 percent of placebo treated patients (N=8) reported improved erections after treatment.
"Treating men for ED caused by a spinal cord injury is a complicated task. These results are encouraging for men who suffer from spinal cord injury," said Francois Giuliano, MD, PhD, Neuro-Urology Unit, Department of Physical Medicine and Rehabilitation, Raymond Poincare Hospital, Garches and Medical University of Paris West, France. "Tadalafil was not only effective in improving erections, it enabled more than half the men receiving tadalafil in the trial to achieve a normal erectile function score."
Study Design
In this study, 186 patients with a mean age of 38 were randomized to receive placebo or Cialis in a double-blind, parallel, flexible-dose study in four European countries (France, Germany, Italy and Spain). Patients were treated for 12 weeks with assessments after each four-week interval.
Following a four-week, treatment-free run-in period, patients were randomized to 10 mg Cialis or placebo. After this first treatment interval, patients receiving 10 mg Cialis were either increased to 20 mg Cialis or left unchanged based on patient response to the 10 mg Cialis dose. After the second treatment interval, Cialis dosing was increased, decreased, or unchanged, based on patient response to the first treatment interval.
The study population included patients with varying degrees of SCI severity. As determined by the American Spinal Injury Association (ASIA) scale, 69.4 percent (N=186) of patients had a complete spinal cord lesion, reflecting the greatest degree of neurological impairment. Further, patients with all levels of the spinal lesion (N=179, 84.3 percent thoracic or lumbo- sacral lesions) and all degrees of erectile dysfunction (N=184, 69 percent of patients had moderate to severe ED) were included.
Study results show that Cialis improved all efficacy endpoints when compared with placebo (p < 0.001). Cialis was generally well tolerated with mild or moderate treatment-emergent adverse events. The most common treatment-emergent adverse events (greater than or equal to 5 percent incidence) were headache (8.5 percent Cialis; 4.5 percent placebo) and urinary tract infection (7.7 percent Cialis; 6.8 percent placebo). Discontinuation due to an adverse event occurred in 2.8 percent of the patients receiving tadalafil and 2.3 percent of those receiving placebo.
About ED
ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. ED affects an estimated 189 million men worldwide.(9) Experts believe that 80 - 90 percent of ED cases are related to a physical or medical condition, like diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 - 20 percent are due to psychological causes.(10,11) In many cases, however, both psychological and physical factors contribute to the condition.(12)
About Cialis
Cialis (tadalafil) was approved by the FDA in November 2003 for the treatment of erectile dysfunction. Cialis is available by prescription only and is not for everyone. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. The most common side effects with Cialis were headache, upset stomach, delayed backache or muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury. Men should not drink alcohol in excess with Cialis.
Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision. It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision, he should stop taking any ED tablet and seek immediate medical attention.
Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. The standard recommended starting dose of Cialis for most patients is 10 mg. Patients with certain medical conditions or taking concomitant medications may need to start at a lower dose. For full patient information, visit http://www.cialis.com.
The Penile Suspensory Ligament: Abnormalities And Repair
The penile suspensory ligament (PSL) supports and maintains the erect penis in an upright position during sexual intercourse. The suspensory apparatus of the penis consists of the fundiform ligament, the suspensory ligament proper and the arcuate subpubic ligament. The fundiform ligament is superficial and not adherent to the tunica albuginea, whilst the suspensory ligament proper bridges between the symphysis pubis and the tunica albuginea of the corpus cavernosum and circumscribes the dorsal vein of the penis. The arcuate subpubic ligament runs a similar course to the suspensory ligament proper; it is a slightly denser structure and lies further posterior. Functionally, the PSL maintains the base of the penis in front of the pubis and acts as a major point of support for the erect penis during intercourse.
A group from St. Peter's Hospital in London, UK led by Chi-Ying Li report on a group of 35 men with abnormalities of the PSL who subsequently underwent repair. The report is published in the January 2007 issue of BJU International.
Fifteen of the 35 men presented with PSL abnormalities after sexual trauma from forced downwards pressure of the erect penis. They complained of penile instability, deformity and variable degrees of erectile dysfunction (ED). The other men had similar complaints but no distinct history of a traumatic injury. All men underwent a detailed medical history and had the physical exam finding of a palpable gap between the pubis and the penis which was more evident when the men were given a pharmacologically induced erection.
The surgical technique of repair included identifying the PSL via a transverse suprapubic incision. Once identified, the PSL was reinforced or repaired using nonabsorbable no. 1 Nylon sutures placed from the midline of the tunica to the pubic symphysis, until the optimal functional penile position was achieved as documented by an artificial erection test. The mean number of sutures required was 4. When there was also penile curvature present (21 men), the curvature was corrected at the same time using a variety of techniques such as Nesbit's procedure or plaque incision and grafting. After surgery, men were asked to delay sexual intercourse for 6 weeks.
Analysis of results revealed that thirty-two of 35 men (91%) had a straight penis; two men had a residual curvature < 15 degrees and one had 25 degrees of residual curvature. Two men (6%) developed de novo ED, which was successfully treated with sildenafil. Both of these men had repair of the PSL and a Nesbit procedure for penile curvature. Two men who presented with venogenic ED were cured as were all of the men who presented with penile pain. There were no postoperative complications although three men had a repeat procedure for inadequate results including one who had penile dysmorphic disorder. The overall satisfaction rate was 86% (30 of 35 men).
This report describes the often overlooked problem of an abnormality of the penile suspensory ligament. The diagnosis is largely clinical and can be elicited by physical exam findings. This problem can be induced iatrogenically after the penile suspensory ligament is divided in penile lengthening surgery and the technique for repair described here can be useful in that clinical condition and those that are described in this report.
A group from St. Peter's Hospital in London, UK led by Chi-Ying Li report on a group of 35 men with abnormalities of the PSL who subsequently underwent repair. The report is published in the January 2007 issue of BJU International.
Fifteen of the 35 men presented with PSL abnormalities after sexual trauma from forced downwards pressure of the erect penis. They complained of penile instability, deformity and variable degrees of erectile dysfunction (ED). The other men had similar complaints but no distinct history of a traumatic injury. All men underwent a detailed medical history and had the physical exam finding of a palpable gap between the pubis and the penis which was more evident when the men were given a pharmacologically induced erection.
The surgical technique of repair included identifying the PSL via a transverse suprapubic incision. Once identified, the PSL was reinforced or repaired using nonabsorbable no. 1 Nylon sutures placed from the midline of the tunica to the pubic symphysis, until the optimal functional penile position was achieved as documented by an artificial erection test. The mean number of sutures required was 4. When there was also penile curvature present (21 men), the curvature was corrected at the same time using a variety of techniques such as Nesbit's procedure or plaque incision and grafting. After surgery, men were asked to delay sexual intercourse for 6 weeks.
Analysis of results revealed that thirty-two of 35 men (91%) had a straight penis; two men had a residual curvature < 15 degrees and one had 25 degrees of residual curvature. Two men (6%) developed de novo ED, which was successfully treated with sildenafil. Both of these men had repair of the PSL and a Nesbit procedure for penile curvature. Two men who presented with venogenic ED were cured as were all of the men who presented with penile pain. There were no postoperative complications although three men had a repeat procedure for inadequate results including one who had penile dysmorphic disorder. The overall satisfaction rate was 86% (30 of 35 men).
This report describes the often overlooked problem of an abnormality of the penile suspensory ligament. The diagnosis is largely clinical and can be elicited by physical exam findings. This problem can be induced iatrogenically after the penile suspensory ligament is divided in penile lengthening surgery and the technique for repair described here can be useful in that clinical condition and those that are described in this report.
Prostatectomy: Know Your Surgeon And Understand Your Risks
You've been diagnosed with localized prostate cancer, and after talking with your urologist, you've decided to undergo radical prostatectomy, or surgical removal of the prostate.
Now that you've made a treatment choice, more questions remain: Which surgical technique is the best? Will it render me incontinent or impotent? What happens after surgery?
However, one question may be the most important, according to a new study involving a Cleveland Clinic researcher: Who will do the surgery?
"There's very clear evidence that shows that the experience of the surgeon is the most important factor in determining the likelihood of a cure, the return of continence and the return of potency," said Eric Klein, M.D., head of the Section of Urologic Oncology at Cleveland Clinic's Glickman Urological and Kidney Institute and one of the study's authors, according to the Cleveland Clinic's Men's Health Advisor. "The most important factor is finding the most experienced surgeon you can and querying him or her on their results."
When opting for prostatectomy, it's important that you not only know your surgeon's experience, but also understand the risks and side effects of surgery and your long-term outlook.
Prostate surgery: Who over how?
For years, most urologic surgeons have used standard radical retropubic prostatectomy, an open surgery in which the surgeon removes the prostate through an incision (about five to eight inches long) in the lower abdomen.
However, minimally invasive laparoscopic surgery is becoming more popular. In this more challenging operation, the surgeon makes five small incisions and uses a tiny camera and specialized instruments to remove the prostate. In a newer laparoscopic technique, robot-assisted surgery, the surgeon removes the prostate with the help of several robotic arms that mimic his hand movements and allow for more precision.
The laparoscopic approach affords the surgeon a magnified view of the prostate. Advantages for the patient include less blood loss, shorter hospital stays and the potential for a faster recovery.
However, these advantages may not matter to you as much a year or more after surgery, Dr. Klein said, and he advises his patients to look at the long-term picture. "You're going to care about whether you're cured, whether you're continent and whether you're potent. When you focus on those, the primary factor becomes experience of the surgeon and not the tools that are used to perform the surgery," he said.
According to Dr. Klein, the recent study found that patients of surgeons who have performed more than 1,000 prostatectomies are about 10 percent more likely to be cured of their cancer than those whose surgeons have done 250 to 999 of the procedures and 30 percent more likely than those whose surgeons have done fewer than 50.
He said preliminary data from another multi-center study in which he participated suggest that men who underwent open surgery had better potency results than those treated with laparoscopic or robotic surgery. "The point it makes to me is there's nothing magical about a laparoscope or a robot," he said. "It's still the surgeon who decides where to cut and where not to cut while doing the surgery."
Dealing with side effects
Prostatectomy is delicate surgery and often affects the nearby urinary sphincter (which controls urine flow through the urethra) and the nerves that allow men to have erections. As a result, most men experience some form of urinary incontinence and impotence (also known as erectile dysfunction, or ED) after a prostatectomy.
Fortunately, post-operative incontinence usually isn't permanent. Most patients regain continence within six to 12 weeks after surgery, some more gradually than others. Some will experience long-term stress incontinence urine leaks when coughing, sneezing or exercising that require men to wear protective pads. Less than one percent suffer from severe incontinence that requires the surgical implanting of an artificial sphincter or urethral sling to control urine flow, Dr. Klein said.
Bilateral nerve-sparing prostatectomy, which preserves the nerve bundles on either side of the prostate, has improved rates of ED after surgery. In the best surgical hands, about 75 percent of all patients who undergo this procedure will regain potency within 12 to 14 months after surgery, according to Dr. Klein.
Others may regain sexual function with the help of drugs such as sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra). Many urologists recommend using these medications immediately after surgery to promote an early return of erections. Other treatments such as vacuum erection devices and injections of a substance known as prostaglandin E1 directly into the penis may be used if the ED drugs fail to work. A final option is a penile implant, using inflatable devices or silicone rods.
Several factors may affect your ability to have an erection after a prostatectomy: your age, medical condition, ability to get an erection before surgery and whether the nerve bundles were damaged. Older men and those with other health problems, such as cardiovascular disease or diabetes, usually have more difficulty regaining potency.
"Most patients can expect a return to regular physical activity within a few weeks, regardless of how the surgery's done, and good results with continence and potency," Dr. Klein said.
After your surgery
If you're like the majority of prostatectomy patients with low- or intermediate-risk prostate cancer, you'll receive a favorable pathology report after your surgery and require no additional treatment. You'll follow up with your urologist shortly after surgery and return periodically for blood tests to measure prostate-specific antigen (PSA).
However, if the pathology report reveals lingering cells that may be cancerous, you may need external-beam radiation therapy or other systemic treatments once you recover from surgery, usually about three to six months later.
What You Can Do:
-- Ask your surgeon about the number of prostatectomies he or she has performed and the results of those procedures.
-- Have your doctor explain the risks and benefits of prostatectomy and other treatments, such as radioactive seed implants (brachytherapy) and external-beam radiation therapy.
-- Prostatectomy causes sterility, so if you still hope to father children, talk to your doctor about banking your sperm before surgery.
Male Impotence Drugs May Deserve A Second Look In Women
New studies indicate the three drugs used to treat male impotence also appear to work in females, albeit a little differently, and should give the scientific community pause to take a second look at their potential in the 40 percent of women who report sexual dysfunction, researchers say.
In one of the first studies of the effect of phosphodiesterase Type 5 inhibitors - Viagra®, Levitra® and Cialis® - on the pudendal arteries that supply the penis, vagina and clitoris the blood needed to produce a satisfying sexual experience, Medical College of Georgia researchers showed the drugs relax the artery in male and female rats.
"It shows the drugs need to be investigated more for women and small alterations could make these compounds more effective for women living with these disorders," says Dr. Kyan J. Allahdadi, postdoctoral fellow in physiology at MCG. He's presenting the findings during the 122nd Annual Meeting of the American Physiological Society held in New Orleans April 18-22 as part of the Experimental Biology 2009 scientific conference.
Although there was talk years ago of a pink pill for women to parallel the blue Viagra for men, early clinical trials found essentially no response in women.
MCG researchers decided to look again, first giving a drug to constrict the internal pudendal arteries in male and female rats - as they would be in a non-erect state - then giving doses of each impotency drug to see the impact. The arteries from male rats displayed a relatively standard concentration-dependent relaxation - the more drug they got, the more they relaxed - while in females arteries, there was an initial relaxation then an odd oscillation between relaxation and contraction with subsequent dosing.
While they don't fully understand the swing, the unique female response likely provides more evidence that sexual function is more complex in females, says Dr. R. Clinton Webb, chair of the MCG Department of Physiology and a study author. Scientists define female sexual dysfunction as a multifaceted disorder that includes anatomical, psychological, physiological and social-interpersonal aspects.
MCG researchers have shown part of that complexity may be the smooth muscle cells in the internal pudendal arteries of females communicate, agreeing to contract and relax, while male smooth muscle cells make independent decisions to just relax.
They found one other distinction: females were more sensitive to Viagra®, or sildenafil, while males were most sensitive to Levitra®, or vardenafil.
Previous studies on the effectiveness of these drugs focused on the cavernosal tissue, or penis. The internal pudendal artery actually feeds the penile artery which is buried deep in the penis where numerous caverns enable it to be flaccid when not engorged with blood. Physical stimulation of the area causes the tissue, endothelial cells and nerves to release nitric oxide, a powerful dilator of blood vessels. The system works pretty much the same way in the vagina and clitoris.
"If you have too much constriction or not enough relaxation to allow blood to go through the internal pudendal artery, you are not going to get the net effect of an erection," Dr. Allahdadi says. "That is why we wanted to begin to characterize what was going on in this blood vessel."
Perhaps as importantly, the MCG scientists and others are beginning to believe sexual dysfunction provides an early, or at least visible, clue of vascular disease. Vascular problems, that can result from diabetes, hypertension, high cholesterol and the like, are a major cause of sexual dysfunction in men and women. "You don't feel atherosclerosis but you know darn well if you are not getting an erection," Dr. Webb says. In fact, the MCG scientists are beginning to look at animal models of disease states, such as diabetes, to see what it does to these internal pudendal arteries.
"What we have seen preliminarily is there is big difference in responsiveness in these arteries. The diabetic pudendal arteries are much more sensitive to contraction," Dr. Allahdadi says. They will look at how drugs like Viagra impact that contraction in the days ahead.
In fact MCG scientists suspect one reason that many of the women participants in previous studies of Viagra did not seem to respond is because they did not have vascular problems that could have been circumvented by a drug that relaxes arteries so blood can enter. In men with a healthy vasculature, the drugs likely would still produce a longer erection.
Dr. Rita C. Tostes, associate professor in the MCG Department of Physiology, is a co-author who contributed to the design and analysis of the study.
In one of the first studies of the effect of phosphodiesterase Type 5 inhibitors - Viagra®, Levitra® and Cialis® - on the pudendal arteries that supply the penis, vagina and clitoris the blood needed to produce a satisfying sexual experience, Medical College of Georgia researchers showed the drugs relax the artery in male and female rats.
"It shows the drugs need to be investigated more for women and small alterations could make these compounds more effective for women living with these disorders," says Dr. Kyan J. Allahdadi, postdoctoral fellow in physiology at MCG. He's presenting the findings during the 122nd Annual Meeting of the American Physiological Society held in New Orleans April 18-22 as part of the Experimental Biology 2009 scientific conference.
Although there was talk years ago of a pink pill for women to parallel the blue Viagra for men, early clinical trials found essentially no response in women.
MCG researchers decided to look again, first giving a drug to constrict the internal pudendal arteries in male and female rats - as they would be in a non-erect state - then giving doses of each impotency drug to see the impact. The arteries from male rats displayed a relatively standard concentration-dependent relaxation - the more drug they got, the more they relaxed - while in females arteries, there was an initial relaxation then an odd oscillation between relaxation and contraction with subsequent dosing.
While they don't fully understand the swing, the unique female response likely provides more evidence that sexual function is more complex in females, says Dr. R. Clinton Webb, chair of the MCG Department of Physiology and a study author. Scientists define female sexual dysfunction as a multifaceted disorder that includes anatomical, psychological, physiological and social-interpersonal aspects.
MCG researchers have shown part of that complexity may be the smooth muscle cells in the internal pudendal arteries of females communicate, agreeing to contract and relax, while male smooth muscle cells make independent decisions to just relax.
They found one other distinction: females were more sensitive to Viagra®, or sildenafil, while males were most sensitive to Levitra®, or vardenafil.
Previous studies on the effectiveness of these drugs focused on the cavernosal tissue, or penis. The internal pudendal artery actually feeds the penile artery which is buried deep in the penis where numerous caverns enable it to be flaccid when not engorged with blood. Physical stimulation of the area causes the tissue, endothelial cells and nerves to release nitric oxide, a powerful dilator of blood vessels. The system works pretty much the same way in the vagina and clitoris.
"If you have too much constriction or not enough relaxation to allow blood to go through the internal pudendal artery, you are not going to get the net effect of an erection," Dr. Allahdadi says. "That is why we wanted to begin to characterize what was going on in this blood vessel."
Perhaps as importantly, the MCG scientists and others are beginning to believe sexual dysfunction provides an early, or at least visible, clue of vascular disease. Vascular problems, that can result from diabetes, hypertension, high cholesterol and the like, are a major cause of sexual dysfunction in men and women. "You don't feel atherosclerosis but you know darn well if you are not getting an erection," Dr. Webb says. In fact, the MCG scientists are beginning to look at animal models of disease states, such as diabetes, to see what it does to these internal pudendal arteries.
"What we have seen preliminarily is there is big difference in responsiveness in these arteries. The diabetic pudendal arteries are much more sensitive to contraction," Dr. Allahdadi says. They will look at how drugs like Viagra impact that contraction in the days ahead.
In fact MCG scientists suspect one reason that many of the women participants in previous studies of Viagra did not seem to respond is because they did not have vascular problems that could have been circumvented by a drug that relaxes arteries so blood can enter. In men with a healthy vasculature, the drugs likely would still produce a longer erection.
Dr. Rita C. Tostes, associate professor in the MCG Department of Physiology, is a co-author who contributed to the design and analysis of the study.
Study Reported Tadalafil Taken Once Daily Improved Erectile Function In Men With ED And Sexual Quality Of Life In Couples
Eli Lilly and Company (NYSE: LLY) announced results from a double-blind, placebo-controlled study which showed that tadalafil 5 mg dose taken once daily was generally well-tolerated, improved erectile function for men with erectile dysfunction (ED) and reported improvement in the sexual quality of life scores for men and their female partners. The 12-week study monitored 342 men and their partners, using several scientific questionnaires to assess changes in erectile function and sexual quality of life before and after treatment with a tadalafil once daily dose. The study appears in the May issue of the peer-reviewed Journal of Sexual Medicine.
"This is the first study of tadalafil 5 mg once daily dose in the treatment of men with ED in which the female partner reported improvement in sexual quality of life scores," said lead investigator Eusebio Rubio-Aurioles M.D., Ph.D. "The sexual quality of life scores also improved among males being treated. In addition, this study showed that daily dose of tadalafil is effective and generally well tolerated in the treatment of erectile dysfunction."
Study Findings
The 16-week double-blind, multicenter, randomized study followed 342 men with a minimum three-month history of ED, as well as their female partners who had adequate sexual function as measured by the Female Sexual Function Index (FSFI). Male candidates were excluded from the study if they: 1) had previously used tadalafil; 2) experienced ED as a result of other primary sexual disorders or related surgeries; 3) had a history of other medical conditions or treatments that could negatively impact erectile or cardiovascular function; or 4) had found other phosphodiesterase-5 (PDE5) inhibitor treatments to be ineffective in treating ED. The 26 investigation sites were located in Austria, France, Germany, Mexico and the United States.
In the first, four-week run-in phase of the study, men remained ED treatment-free and were asked to make a minimum of four sexual attempts with their partners. In the second, 12-week treatment phase of the study, men were randomized to receive either a placebo (N=78) or tadalafil 5 mg (N=264) taken once daily and were asked to make at least one sexual attempt with their partner per week.
Subjects were evaluated throughout the study using the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain,(1) Sexual Encounter Profile (SEP) diary(2) and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ).(3) Each couple's responses were captured at entry, the end of each phase and following each sexual attempt. Changes in vital signs were also monitored to evaluate safety.
Results showed that tadalafil 5 mg taken daily significantly improved erectile function according to changes from baseline measured by the IIEF and SEP. The average increase from baseline to endpoint in the IIEF-EF domain was 7.9 points in the tadalafil group, compared with 0.7 points in the placebo group. Men in the tadalafil group reported a 28.6 percent increase on average (compared with 2.7 percent in the placebo group) in the ability to achieve an erection sufficient for vaginal penetration. When asked if their erections lasted long enough for successful intercourse, men in the tadalafil group reported a 46 percent increase on average in positive responses from baseline to endpoint, compared with 10.8 percent in the placebo group.
The study also reported a significant improvement in the sexual quality of life scores for men taking tadalafil once daily and their partners. The average increase in SQoL scores from baseline to endpoint for men in the tadalafil group was 39.5 points, compared with 12.5 point increase in the placebo group. The average increase in SQoL scores for women whose partners were in the tadalafil group was 32.4 points, compared with 5 points in the placebo group.
Tadalafil 5 mg was generally well-tolerated, and the most frequently reported adverse events were headache, dyspepsia and nasal congestion. Three subjects in the tadalafil group discontinued their participation in the study due to adverse events.
About Cialis
Cialis(R) (tadalafil) is approved for the treatment of erectile dysfunction on an as-needed basis or in a daily regimen. The recommended starting dose of Cialis for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. As part of a daily regimen, Cialis may be taken as 2.5 mg or increased to 5 mg, based on individual efficacy and tolerability.
Important Safety Information for Cialis
Cialis is available by prescription only and is not for everyone. Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. Cialis for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating the potential for interactions with certain medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial amounts of alcohol.
Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. Men should not drink alcohol in excess with Cialis. The most common side effects with Cialis were headache, upset stomach, backache or muscle ache.
As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury.
In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision, or a sudden decrease or loss of hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet including Cialis and seek medical attention right away.
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. As of 2004, it is estimated that approximately 189 million men worldwide will have ED.(4) Experts believe that 80 to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 to 20 percent are predominantly due to psychological causes.(5, 6) In many cases, however, both psychological and physical factors contribute to the condition.(7)
About Lilly
Lilly, a leading innovation-driven corporation is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
References
(1) The IIEF is a validated scale that assesses erectile function by measuring treatment-related responses in patients.
(2) The SEP diaries contain five patient diary questions that allow patients to record responses following sexual events.
(3) The SQoL domain contains 10 questions that compare the current sexual experience with the subject's experience prior to the onset of ED.
(4) Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ. Impotence and its Medical and Psychosocial Correlates: Results of the Massachusetts Male Aging Study, Journal of Urology. Vol. 151, 54-61, January 1994 and World Population Projection Program Of United Nations (2002 Revision) with indirect standardization.
(5) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York: Kensington.
(6) Erectile Dysfunction, http://kidney.niddk.nih.gov/kudiseases/pubs/impotence/. Data accessed 09/28/07.
(7) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.
"This is the first study of tadalafil 5 mg once daily dose in the treatment of men with ED in which the female partner reported improvement in sexual quality of life scores," said lead investigator Eusebio Rubio-Aurioles M.D., Ph.D. "The sexual quality of life scores also improved among males being treated. In addition, this study showed that daily dose of tadalafil is effective and generally well tolerated in the treatment of erectile dysfunction."
Study Findings
The 16-week double-blind, multicenter, randomized study followed 342 men with a minimum three-month history of ED, as well as their female partners who had adequate sexual function as measured by the Female Sexual Function Index (FSFI). Male candidates were excluded from the study if they: 1) had previously used tadalafil; 2) experienced ED as a result of other primary sexual disorders or related surgeries; 3) had a history of other medical conditions or treatments that could negatively impact erectile or cardiovascular function; or 4) had found other phosphodiesterase-5 (PDE5) inhibitor treatments to be ineffective in treating ED. The 26 investigation sites were located in Austria, France, Germany, Mexico and the United States.
In the first, four-week run-in phase of the study, men remained ED treatment-free and were asked to make a minimum of four sexual attempts with their partners. In the second, 12-week treatment phase of the study, men were randomized to receive either a placebo (N=78) or tadalafil 5 mg (N=264) taken once daily and were asked to make at least one sexual attempt with their partner per week.
Subjects were evaluated throughout the study using the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain,(1) Sexual Encounter Profile (SEP) diary(2) and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ).(3) Each couple's responses were captured at entry, the end of each phase and following each sexual attempt. Changes in vital signs were also monitored to evaluate safety.
Results showed that tadalafil 5 mg taken daily significantly improved erectile function according to changes from baseline measured by the IIEF and SEP. The average increase from baseline to endpoint in the IIEF-EF domain was 7.9 points in the tadalafil group, compared with 0.7 points in the placebo group. Men in the tadalafil group reported a 28.6 percent increase on average (compared with 2.7 percent in the placebo group) in the ability to achieve an erection sufficient for vaginal penetration. When asked if their erections lasted long enough for successful intercourse, men in the tadalafil group reported a 46 percent increase on average in positive responses from baseline to endpoint, compared with 10.8 percent in the placebo group.
The study also reported a significant improvement in the sexual quality of life scores for men taking tadalafil once daily and their partners. The average increase in SQoL scores from baseline to endpoint for men in the tadalafil group was 39.5 points, compared with 12.5 point increase in the placebo group. The average increase in SQoL scores for women whose partners were in the tadalafil group was 32.4 points, compared with 5 points in the placebo group.
Tadalafil 5 mg was generally well-tolerated, and the most frequently reported adverse events were headache, dyspepsia and nasal congestion. Three subjects in the tadalafil group discontinued their participation in the study due to adverse events.
About Cialis
Cialis(R) (tadalafil) is approved for the treatment of erectile dysfunction on an as-needed basis or in a daily regimen. The recommended starting dose of Cialis for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. As part of a daily regimen, Cialis may be taken as 2.5 mg or increased to 5 mg, based on individual efficacy and tolerability.
Important Safety Information for Cialis
Cialis is available by prescription only and is not for everyone. Men should discuss their medical conditions and all medications with their doctors to ensure Cialis is right for them and that they are healthy enough for sexual activity. Men taking nitrates, often used for chest pain, should not take Cialis. Such a combination could cause a sudden, unsafe drop in blood pressure. Cialis for once daily use provides continuous plasma tadalafil levels which should be considered when evaluating the potential for interactions with certain medications (e.g., nitrates, alpha-blockers, anti-hypertensives and potent inhibitors of CYP3A4) and with substantial amounts of alcohol.
Cialis does not protect a man or his partner from sexually transmitted diseases, including HIV. Men should not drink alcohol in excess with Cialis. The most common side effects with Cialis were headache, upset stomach, backache or muscle ache.
As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury.
In rare instances, men taking prescription ED tablets (including Cialis) reported a sudden decrease or loss of vision, or a sudden decrease or loss of hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If a man has a sudden decrease or loss of vision or hearing, he should stop taking any ED tablet including Cialis and seek medical attention right away.
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. As of 2004, it is estimated that approximately 189 million men worldwide will have ED.(4) Experts believe that 80 to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 to 20 percent are predominantly due to psychological causes.(5, 6) In many cases, however, both psychological and physical factors contribute to the condition.(7)
About Lilly
Lilly, a leading innovation-driven corporation is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
References
(1) The IIEF is a validated scale that assesses erectile function by measuring treatment-related responses in patients.
(2) The SEP diaries contain five patient diary questions that allow patients to record responses following sexual events.
(3) The SQoL domain contains 10 questions that compare the current sexual experience with the subject's experience prior to the onset of ED.
(4) Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ. Impotence and its Medical and Psychosocial Correlates: Results of the Massachusetts Male Aging Study, Journal of Urology. Vol. 151, 54-61, January 1994 and World Population Projection Program Of United Nations (2002 Revision) with indirect standardization.
(5) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost Intimacy. New York: Kensington.
(6) Erectile Dysfunction, http://kidney.niddk.nih.gov/kudiseases/pubs/impotence/. Data accessed 09/28/07.
(7) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.
Erectile Dysfunction And Diabetes
A new study sheds additional light on how erectile dysfunction (ED) interacts with diabetes. The study is another step in uncovering the link between the two disorders, and may lead to improved efficacy in treatments.
The study, "Lack of Central Nitric Oxide Triggers Erectile Dysfunction in Diabetes," was conducted by Hong Zheng, William G. Mayhan, and Kaushik P. Patel, Departments of Cellular and Integrative Physiology; and Keshore R. Bidasee, Department of Pharmacology, University of Nebraska Medical Center, Omaha, NE. The results appear in the March 2007 edition of the American Journal of Physiology - Regulatory, Integrative and Comparative Physiology, one of 11 peer-reviewed scientific publications issued monthly by The American Physiological Society (APS) (http://www.the-aps.org/).
Background
Sexual dysfunction is a well-recognized consequence of diabetes mellitus in men. Erectile dysfunction, retrograde ejaculation and the loss of seminal emission have all been described by such patients. This study examined induced penile erection, yawning and stretch in diabetic rats. Male Sprague-Dawley rats treated with streptozotocin (STZ) to induce diabetes were used as they exhibit sexual and behavioral symptoms similar to those found in diabetic men with sexual dysfunction.
The researchers focused on the paraventricular nucleus (PVN) of the hypothalamus, located in the brain, an integration center between the central and peripheral nervous systems. The site is involved in numerous functions, including erectile function and sexual behavior, and is a primary site within the forebrain that has been implicated in penile erection. The investigators also examined central nitric oxide (NO within the PVN) which plays an important role in the neurotransmission of normal penile erection.
Penile erection is a behavioral response that occurs in response to the administration of N-methyl-D-aspartic acid (NMDA) within the PVN. At the same time, inhibition of NO synthase with NG-monomethly-L-argining (L-NMMA) prevents NMDA-induced erection. The researchers hypothesized that the blunted NMDA mediated responses in diabetes reflects an impaired NO mechanism within the PVN. The involvement of an NO mechanism in the NMDA mediated behavioral response was also explored.
Methodology
The rats were exposed to a light/dark cycle, with standard temperature and humidity levels. The animals were randomly selected to receive chemical injection of the streptozotocin (STZ) to induce diabetes. Those rats that did not receive STZ (vehicle injected) served as controls. The experiments began on each of the rats four weeks after the injections.
Four experiments were conducted. Experiment one examined the effect of L-NMMA on NMDA mediated behavioral responses in normal rats; experiment two measured behavioral responses to NMDA or sodium nitroprusside (SNP), an NO donor in both control and diabetic rats; the third experiment observed the effect of diabetes on nNOS protein in the PVN; the fourth experiment measured NMDA mediated behavioral responses in diabetic rats after restoring the nNOS protein in the PVN using viral gene transfer.
Results
The researchers found that:
* when L-NMMA was used to block NO production in the PVN, NMDA mediated penile erectile responses were blunted
* NMDA-induced erections were significantly blunted in diabetic rats compared with control rats
* the nNOS protein levels in the PVN were decreased in rats with diabetes and
* restoring nNOS protein within the PVN of diabetic rats with viral gene transfer could alleviate the blunted NMDA induced erectile responses.
Conclusion
The researchers conclude that erectile dysfunction in diabetes is due to a selective defect in the NO mechanisms within the PVN. This defect is a loss in the synthetic enzyme for the production of NO within the neurons of the PVN. Restoring this synthetic enzyme may have a significant therapeutic value for diabetic patients with ED.
The study, "Lack of Central Nitric Oxide Triggers Erectile Dysfunction in Diabetes," was conducted by Hong Zheng, William G. Mayhan, and Kaushik P. Patel, Departments of Cellular and Integrative Physiology; and Keshore R. Bidasee, Department of Pharmacology, University of Nebraska Medical Center, Omaha, NE. The results appear in the March 2007 edition of the American Journal of Physiology - Regulatory, Integrative and Comparative Physiology, one of 11 peer-reviewed scientific publications issued monthly by The American Physiological Society (APS) (http://www.the-aps.org/).
Background
Sexual dysfunction is a well-recognized consequence of diabetes mellitus in men. Erectile dysfunction, retrograde ejaculation and the loss of seminal emission have all been described by such patients. This study examined induced penile erection, yawning and stretch in diabetic rats. Male Sprague-Dawley rats treated with streptozotocin (STZ) to induce diabetes were used as they exhibit sexual and behavioral symptoms similar to those found in diabetic men with sexual dysfunction.
The researchers focused on the paraventricular nucleus (PVN) of the hypothalamus, located in the brain, an integration center between the central and peripheral nervous systems. The site is involved in numerous functions, including erectile function and sexual behavior, and is a primary site within the forebrain that has been implicated in penile erection. The investigators also examined central nitric oxide (NO within the PVN) which plays an important role in the neurotransmission of normal penile erection.
Penile erection is a behavioral response that occurs in response to the administration of N-methyl-D-aspartic acid (NMDA) within the PVN. At the same time, inhibition of NO synthase with NG-monomethly-L-argining (L-NMMA) prevents NMDA-induced erection. The researchers hypothesized that the blunted NMDA mediated responses in diabetes reflects an impaired NO mechanism within the PVN. The involvement of an NO mechanism in the NMDA mediated behavioral response was also explored.
Methodology
The rats were exposed to a light/dark cycle, with standard temperature and humidity levels. The animals were randomly selected to receive chemical injection of the streptozotocin (STZ) to induce diabetes. Those rats that did not receive STZ (vehicle injected) served as controls. The experiments began on each of the rats four weeks after the injections.
Four experiments were conducted. Experiment one examined the effect of L-NMMA on NMDA mediated behavioral responses in normal rats; experiment two measured behavioral responses to NMDA or sodium nitroprusside (SNP), an NO donor in both control and diabetic rats; the third experiment observed the effect of diabetes on nNOS protein in the PVN; the fourth experiment measured NMDA mediated behavioral responses in diabetic rats after restoring the nNOS protein in the PVN using viral gene transfer.
Results
The researchers found that:
* when L-NMMA was used to block NO production in the PVN, NMDA mediated penile erectile responses were blunted
* NMDA-induced erections were significantly blunted in diabetic rats compared with control rats
* the nNOS protein levels in the PVN were decreased in rats with diabetes and
* restoring nNOS protein within the PVN of diabetic rats with viral gene transfer could alleviate the blunted NMDA induced erectile responses.
Conclusion
The researchers conclude that erectile dysfunction in diabetes is due to a selective defect in the NO mechanisms within the PVN. This defect is a loss in the synthetic enzyme for the production of NO within the neurons of the PVN. Restoring this synthetic enzyme may have a significant therapeutic value for diabetic patients with ED.
New Study Shows LEVITRA Successfully Treats Erectile Dysfunction (ED) In Men With Dyslipidemia, Including High Cholesterol
Results of the first prospective trial specifically designed to evaluate erectile function in erectile dysfunction (ED) patients with dyslipidemia show that LEVITRA(R) (vardenafil HCl), used in treating ED, significantly improves the ability of men with ED and dyslipidemia to achieve and maintain an erection for successful sexual intercourse. These data were presented at the Sexual Medicine Society of North America (SMSNA) Fall Meeting held in Chicago, IL.
The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that LEVITRA significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition," said Dr. Martin Miner, Clinical Associate Professor of Family Medicine at Brown University's Warren Alpert School of Medicine. "This study provides further support that LEVITRA can successfully treat ED, even in men with a serious common condition like high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of LEVITRA in men with ED who also have high blood pressure or diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomized to treatment with LEVITRA or placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs. 51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the LEVITRA group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects (occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for placebo).
Background: Erectile dysfunction
Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. ED can be a total inability to achieve an erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. It is estimated that some degree of ED affects up to 30 million men in the United States.
Some of the most common treatments for ED include adjustments to lifestyle and better control of concomitant medical conditions as well as the use of oral medications or other forms of therapy. Treating related health conditions or reducing stress may help maintain erectile function.
About LEVITRA
LEVITRA (vardenafil HCl) is a prescription medicine that is indicated to treat erectile dysfunction (ED). Consistent with the effects of PDE5 inhibition, administration of LEVITRA with nitrates and nitric oxide donors is contraindicated.
Caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with stable alpha-blocker therapy, because of the potential for lowering blood pressure.
LEVITRA is not recommended for patients with uncontrolled hypertension (>170/110 mmHg).
In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.
In patients taking certain CYP3A4 inhibitors (eg, ritonavir, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, and clarithromycin), lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended. See prescribing information for LEVITRA for dosing guidance.
In clinical trials, the most commonly reported adverse events with LEVITRA were headache, flushing, and rhinitis. Adverse events were generally transient.
Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely postmarketing in temporal relationship with the use of PDE5 inhibitors, including LEVITRA. Sudden loss of hearing, sometimes with tinnitus and dizziness, also has been reported rarely in temporal association with the use of PDE5 inhibitors, including LEVITRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden loss of vision or hearing.
The recommended starting dose of LEVITRA is 10 mg. Titrate up to 20 mg or down to 5 mg based on efficacy and side effects.
The maximum recommended dosing frequency is once daily. LEVITRA is available in 2.5-mg, 5-mg, 10-mg and 20-mg tablets. For Prescribing Information please visit http://www.levitra.com.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "To Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential market for LEVITRA. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that LEVITRA significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition," said Dr. Martin Miner, Clinical Associate Professor of Family Medicine at Brown University's Warren Alpert School of Medicine. "This study provides further support that LEVITRA can successfully treat ED, even in men with a serious common condition like high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of LEVITRA in men with ED who also have high blood pressure or diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomized to treatment with LEVITRA or placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs. 51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the LEVITRA group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects (occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for placebo).
Background: Erectile dysfunction
Erectile dysfunction (ED) is the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. ED can be a total inability to achieve an erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. It is estimated that some degree of ED affects up to 30 million men in the United States.
Some of the most common treatments for ED include adjustments to lifestyle and better control of concomitant medical conditions as well as the use of oral medications or other forms of therapy. Treating related health conditions or reducing stress may help maintain erectile function.
About LEVITRA
LEVITRA (vardenafil HCl) is a prescription medicine that is indicated to treat erectile dysfunction (ED). Consistent with the effects of PDE5 inhibition, administration of LEVITRA with nitrates and nitric oxide donors is contraindicated.
Caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with stable alpha-blocker therapy, because of the potential for lowering blood pressure.
LEVITRA is not recommended for patients with uncontrolled hypertension (>170/110 mmHg).
In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.
In patients taking certain CYP3A4 inhibitors (eg, ritonavir, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, and clarithromycin), lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended. See prescribing information for LEVITRA for dosing guidance.
In clinical trials, the most commonly reported adverse events with LEVITRA were headache, flushing, and rhinitis. Adverse events were generally transient.
Nonarteritic anterior ischemic optic neuropathy (NAION) has been reported rarely postmarketing in temporal relationship with the use of PDE5 inhibitors, including LEVITRA. Sudden loss of hearing, sometimes with tinnitus and dizziness, also has been reported rarely in temporal association with the use of PDE5 inhibitors, including LEVITRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden loss of vision or hearing.
The recommended starting dose of LEVITRA is 10 mg. Titrate up to 20 mg or down to 5 mg based on efficacy and side effects.
The maximum recommended dosing frequency is once daily. LEVITRA is available in 2.5-mg, 5-mg, 10-mg and 20-mg tablets. For Prescribing Information please visit http://www.levitra.com.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at http://www.gsk.com.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "To Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential market for LEVITRA. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
BioSpecifics Technologies Corp. Announces Initiation Of Phase IIb Trial For Peyronie's Disease
BioSpecifics Technologies Corp. (OTC Bulletin Board: BSTC), a biopharmaceutical company developing first in class collagenase based products, announced the initiation of a U.S. Phase IIb clinical trial in Peyronie's disease for its injectable collagenase, XIAFLEX (TM), by its partner Auxlium Pharmaceuticals, Inc.
"We are very pleased that our partner has chosen to advance this trial into a Phase IIb based on our extremely encouraging IIa results that showed a statistically significant reduction of angle of penile curvature and improvement in sexual satisfaction," stated Thomas Wegman, President of BioSpecifics Technologies Corp. "Peyronie's disease affects over 1 million men worldwide and there are no currently effective pharmaceutical therapies. We are happy to be one step closer to making this minimally invasive therapy available for those that need it and we look forward to the anticipated trial results that will be announced by the end of 2009."
The Phase IIb study is a randomized, double-blind, placebo-controlled study that is designed to assess the safety and efficacy of XIAFLEX, when administered two times a week every six weeks for up to three treatment cycles (2 x 3), in subjects with Peyronie's disease. The study will involve at least 120 patients at approximately 11 sites throughout the U.S., and patients will be monitored for 36 weeks following the first injection.
The trial is also designed to validate a proprietary Peyronie's Patient Reported Outcome (PRO) questionnaire, which will measure several domains of patients' sexual quality of life, over a 36 week period. The four domains measured by the PRO are penile pain, Peyronie's disease bother, intercourse discomfort and intercourse constraint.
To qualify for the study, patients must be able to maintain a rigid erection and have a penile contracture between 30 and 90 degrees. Patients will be stratified by the degree of penile curvature (i.e. 30 degrees to 60 degrees versus > 60 degrees) and then randomized into 4 treatment groups to receive either XIAFLEX or placebo with or without modeling of the penile plaque. Modeling refers to massaging of the plaque after the second injection of a treatment series and is intended to maximize the enzymatic effect of the XIAFLEX injection in the plaque. Patients will be randomized in a 3:1 ratio of XIAFLEX to placebo and a 1:1 ratio to receive penile plaque modeling or no modeling.
About Peyronie's Disease
Peyronie's disease is characterized by the presence of a collagen plaque on the shaft of the penis, which can distort an erection and make intercourse difficult or impossible in advanced cases. The plaque is not elastic and it does not stretch during erection. In some mild cases, the plaque can resolve spontaneously without medical intervention. The most common plaque forms on the top of the penis causing the penis to arc upward. In severe cases, the penis can be bent at a 90-degree angle during erection. Significant psychological distress has been noted in patients with Peyronie's disease who are sexually active. Frequent patient complaints include increased pain, painful erections, palpable plaque, penile deformity, and erectile dysfunction. Patients with Peyronie's disease have been reported to have an increased likelihood of having Dupuytren's disease, frozen shoulder, plantar fibromatosis, knuckle pads, hypertension and diabetes. Peyronie's disease typically affects males in the range of 40-70 years. The cause of Peyronie's disease is unknown, although some investigators have proposed that it may be due to trauma or an autoimmune component. A number of researchers have suggested that the incidence of Peyronie's disease has increased due to the use of erectile dysfunction drugs.
"We are very pleased that our partner has chosen to advance this trial into a Phase IIb based on our extremely encouraging IIa results that showed a statistically significant reduction of angle of penile curvature and improvement in sexual satisfaction," stated Thomas Wegman, President of BioSpecifics Technologies Corp. "Peyronie's disease affects over 1 million men worldwide and there are no currently effective pharmaceutical therapies. We are happy to be one step closer to making this minimally invasive therapy available for those that need it and we look forward to the anticipated trial results that will be announced by the end of 2009."
The Phase IIb study is a randomized, double-blind, placebo-controlled study that is designed to assess the safety and efficacy of XIAFLEX, when administered two times a week every six weeks for up to three treatment cycles (2 x 3), in subjects with Peyronie's disease. The study will involve at least 120 patients at approximately 11 sites throughout the U.S., and patients will be monitored for 36 weeks following the first injection.
The trial is also designed to validate a proprietary Peyronie's Patient Reported Outcome (PRO) questionnaire, which will measure several domains of patients' sexual quality of life, over a 36 week period. The four domains measured by the PRO are penile pain, Peyronie's disease bother, intercourse discomfort and intercourse constraint.
To qualify for the study, patients must be able to maintain a rigid erection and have a penile contracture between 30 and 90 degrees. Patients will be stratified by the degree of penile curvature (i.e. 30 degrees to 60 degrees versus > 60 degrees) and then randomized into 4 treatment groups to receive either XIAFLEX or placebo with or without modeling of the penile plaque. Modeling refers to massaging of the plaque after the second injection of a treatment series and is intended to maximize the enzymatic effect of the XIAFLEX injection in the plaque. Patients will be randomized in a 3:1 ratio of XIAFLEX to placebo and a 1:1 ratio to receive penile plaque modeling or no modeling.
About Peyronie's Disease
Peyronie's disease is characterized by the presence of a collagen plaque on the shaft of the penis, which can distort an erection and make intercourse difficult or impossible in advanced cases. The plaque is not elastic and it does not stretch during erection. In some mild cases, the plaque can resolve spontaneously without medical intervention. The most common plaque forms on the top of the penis causing the penis to arc upward. In severe cases, the penis can be bent at a 90-degree angle during erection. Significant psychological distress has been noted in patients with Peyronie's disease who are sexually active. Frequent patient complaints include increased pain, painful erections, palpable plaque, penile deformity, and erectile dysfunction. Patients with Peyronie's disease have been reported to have an increased likelihood of having Dupuytren's disease, frozen shoulder, plantar fibromatosis, knuckle pads, hypertension and diabetes. Peyronie's disease typically affects males in the range of 40-70 years. The cause of Peyronie's disease is unknown, although some investigators have proposed that it may be due to trauma or an autoimmune component. A number of researchers have suggested that the incidence of Peyronie's disease has increased due to the use of erectile dysfunction drugs.
The Unsatisfied Need for Obviating Erectile Dysfunction
There is an unsatisfied need for obviating Erectile Dysfunction that current drugs cannot meet.
AE Medical is a Massachusetts biotech corporation, and the owner of intellectual property on devices and methods enabling AE technology to enter vast erectile dysfunction markets now dominated by Erectile Dysfunction (ED) drugs such as Viagra.
Last year Viagra gained $2 billion in sales for Pfizer, nearly 60 percent of which was in the United States. In addition, all new ED drugs on the market work by blocking an enzyme called PDE-5, which affects penile blood flow, but not without potentially harmful side-effects.
A large business opportunity is created by the need and demand of the estimated 30 million men over 40 years of age who cannot achieve an erection with Viagra or any other ED drug treatment.
Analysts at Merrill Lynch believe there is room for new entrant competition for erectile dysfunction, since their estimate is that more than 28 percent of male patients who have tried Viagra and other internal, invasive ED drugs with side-effects, and after extended trials are left unfulfilled and frustrated because they simply cannot achieve an adequate erection for sexual intercourse.
The AE proprietary external, non-invasive technology without side-effects, proven to be effective for men who cannot benefit from ED drugs, and a much lower cost ED device solution and method. The present refined and tested, easier to use AE device for non-prescription, over the counter sales, has been proven reliable and capable of consistent, repeatable erection enhancement and performance for all men.
The main AE business strategy is to produce and market this safe, full-erection capability directly to the consumer through advertising, Internet web sites, mail order, retail stores, and pharmacies. Only licensed medical physicians can prescribe Viagra, and medical insurance for all males generally limits payment for only about four ED drug pills per month at a cost of about $500 per year.
Since the AE device is reusable and costs significantly less than Viagra, there is a larger ready market for AE Medical, with the only practical, effective erectile device for all men to enhance their performance.
The AE device and method was originally designed and developed with a Urologist under a CDA for an older patient with Impotence who was operated on for Prostate Cancer and is also a Type II diabetic. AE conducted further research with a Cardiologist in Internal Medicine, who wants to have an ED alternative to replace the use of Viagra and related ED drugs with their side effects and the attendant cardiovascular risks.
AE is reviewing the design with the FDA for final release to production and sales through Physicians and Medicare approved outlets.
David Estabrooks has a (CDA) Confidential Disclosure Agreement with members of the Joslin Diabetic Clinic for their interest in the AE external penile device for erection capability in Diabetic men, where more than 50% have unsolved erectile dysfunction. AE Medical is planning to obtain FDA approval and Medicare authorization for 80% reimbursement in order to satisfy the prescription ED device demand by physicians.
AE Erectile Devices are designed over counter, non-prescription and consumer sales. But also to meet external ED device FDA guidelines and materials standards for Medicare and medical prescription by physicians, the proprietary AE device and method is the only solution capable of effectively creating erections, and at the lowest possible cost.
Without a strict requirement for a prescription by a physician, AE can easily thru conventional sales outlets, enter into the rapidly growing Viagra dominated marketplace for all male age groups.
Since Viagra is only prescribed by licensed medical physicians, medical insurance for males generally limits payment for only about four Viagra pills per month at a cost of about $50, AE Medical will have a significant low price advantage with much less restriction of use by all males.
Medicare has a patient reimbursement program with a physician's prescription for any FDA approved external, non-invasive ED devices and methods without side-effects. And, in the case Medicare reimbursement with a physcian, AE will have a very large market.
At much lower consumer cost, simple, reliable AE products will capture large sales revenues with adequate profit margins for AE Medical investors. The AE business strategy is to become the most popular penile erection treatment for erectile dysfunction.
The new AE products will succeed, where other current ED devices for obviating erectile dysfunction have failed in achieving substantial revenue growth in supplanting Viagra and other ED drugs. AE will follow this focused, logical progression to make its high quality, low cost, safe effective product, the preferred ED solution, the "must have" AE erection device and method.
With the potential for large customer interest and demand, U.S. Patent Applications are filed to protect the AE Apparatus and Method for Obviating Erectile Dysfunction. There are no competitive products currently on the market, and no evidence of prior art, or any patent like the proprietary AE Technology.
It is anticipated that AE Erectile Devices due to their simplicity and ease of use will enjoy a high success rate with increasing consumer and medical acceptance.
AE will change the face of the erectile treatment industry over the next few years. It is planned that the AE venture development will be financed entirely with individual and angel investment in AE Medical Common Stock.
Additional funding will be derived with hospitals such as the Joslin Diabetic Clinic and other institutions becoming involved in licensing and sales participation.
It is estimated that the first stage of product development, manufacture, and sales does not require more than $350,000 to reach profitability. For investor information and a CDA to learn more about this revolutionary AE Technology,
AE Medical is a Massachusetts biotech corporation, and the owner of intellectual property on devices and methods enabling AE technology to enter vast erectile dysfunction markets now dominated by Erectile Dysfunction (ED) drugs such as Viagra.
Last year Viagra gained $2 billion in sales for Pfizer, nearly 60 percent of which was in the United States. In addition, all new ED drugs on the market work by blocking an enzyme called PDE-5, which affects penile blood flow, but not without potentially harmful side-effects.
A large business opportunity is created by the need and demand of the estimated 30 million men over 40 years of age who cannot achieve an erection with Viagra or any other ED drug treatment.
Analysts at Merrill Lynch believe there is room for new entrant competition for erectile dysfunction, since their estimate is that more than 28 percent of male patients who have tried Viagra and other internal, invasive ED drugs with side-effects, and after extended trials are left unfulfilled and frustrated because they simply cannot achieve an adequate erection for sexual intercourse.
The AE proprietary external, non-invasive technology without side-effects, proven to be effective for men who cannot benefit from ED drugs, and a much lower cost ED device solution and method. The present refined and tested, easier to use AE device for non-prescription, over the counter sales, has been proven reliable and capable of consistent, repeatable erection enhancement and performance for all men.
The main AE business strategy is to produce and market this safe, full-erection capability directly to the consumer through advertising, Internet web sites, mail order, retail stores, and pharmacies. Only licensed medical physicians can prescribe Viagra, and medical insurance for all males generally limits payment for only about four ED drug pills per month at a cost of about $500 per year.
Since the AE device is reusable and costs significantly less than Viagra, there is a larger ready market for AE Medical, with the only practical, effective erectile device for all men to enhance their performance.
The AE device and method was originally designed and developed with a Urologist under a CDA for an older patient with Impotence who was operated on for Prostate Cancer and is also a Type II diabetic. AE conducted further research with a Cardiologist in Internal Medicine, who wants to have an ED alternative to replace the use of Viagra and related ED drugs with their side effects and the attendant cardiovascular risks.
AE is reviewing the design with the FDA for final release to production and sales through Physicians and Medicare approved outlets.
David Estabrooks has a (CDA) Confidential Disclosure Agreement with members of the Joslin Diabetic Clinic for their interest in the AE external penile device for erection capability in Diabetic men, where more than 50% have unsolved erectile dysfunction. AE Medical is planning to obtain FDA approval and Medicare authorization for 80% reimbursement in order to satisfy the prescription ED device demand by physicians.
AE Erectile Devices are designed over counter, non-prescription and consumer sales. But also to meet external ED device FDA guidelines and materials standards for Medicare and medical prescription by physicians, the proprietary AE device and method is the only solution capable of effectively creating erections, and at the lowest possible cost.
Without a strict requirement for a prescription by a physician, AE can easily thru conventional sales outlets, enter into the rapidly growing Viagra dominated marketplace for all male age groups.
Since Viagra is only prescribed by licensed medical physicians, medical insurance for males generally limits payment for only about four Viagra pills per month at a cost of about $50, AE Medical will have a significant low price advantage with much less restriction of use by all males.
Medicare has a patient reimbursement program with a physician's prescription for any FDA approved external, non-invasive ED devices and methods without side-effects. And, in the case Medicare reimbursement with a physcian, AE will have a very large market.
At much lower consumer cost, simple, reliable AE products will capture large sales revenues with adequate profit margins for AE Medical investors. The AE business strategy is to become the most popular penile erection treatment for erectile dysfunction.
The new AE products will succeed, where other current ED devices for obviating erectile dysfunction have failed in achieving substantial revenue growth in supplanting Viagra and other ED drugs. AE will follow this focused, logical progression to make its high quality, low cost, safe effective product, the preferred ED solution, the "must have" AE erection device and method.
With the potential for large customer interest and demand, U.S. Patent Applications are filed to protect the AE Apparatus and Method for Obviating Erectile Dysfunction. There are no competitive products currently on the market, and no evidence of prior art, or any patent like the proprietary AE Technology.
It is anticipated that AE Erectile Devices due to their simplicity and ease of use will enjoy a high success rate with increasing consumer and medical acceptance.
AE will change the face of the erectile treatment industry over the next few years. It is planned that the AE venture development will be financed entirely with individual and angel investment in AE Medical Common Stock.
Additional funding will be derived with hospitals such as the Joslin Diabetic Clinic and other institutions becoming involved in licensing and sales participation.
It is estimated that the first stage of product development, manufacture, and sales does not require more than $350,000 to reach profitability. For investor information and a CDA to learn more about this revolutionary AE Technology,