It works.
D Ewards wrote:
<<<As a VVUS shareholder, the only significant issue is simple:
Does the product work for the average ED patient?>>>
Well if you think the whole thing is a fraud, then I guess you won't believe this either. By the way, your "urologist" has no profile on aol, and frankly, urology is a surgical specialty, not too many are "happy" with a lot of office visits as opposed to being in the OR. Of course now that the bottom is dropping out of the penile implant business........
vivus.com
VIVUS filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for its first product, MUSE(alprostadil) urethral suppository for consideration on March 27, 1996. MUSE received priority review status by the FDA and was cleared for marketing on November 19, 1996.
In preparation for the filing, VIVUS completed pivotal Phase III studies, which were the largest, prospective, double-blind, placebo-controlled studies ever undertaken in men with severe, organic erectile dysfunction. These studies enrolled spouses as well as patients, collecting information about response to treatment from both partners. During the home treatment phase, sixty-five percent of patients using MUSE (alprostadil) reported successful intercourse compared with nineteen percent of the placebo patients. The studies also demonstrated that the effectiveness of MUSE (alprostadil) is independent of patient age or the cause of erectile dysfunction. In addition, successful treatment with MUSE (alprostadil) resulted in a statistically significant improvement in the relationship between patients and their partners, and in the patient's perception of his well-being.
Recent estimates suggest that the number of men in the United States with erectile dysfunction may range from 10 to 20 million. VIVUS believes that similar rates of erectile dysfunction prevail outside the United States. The incidence of the problem increases exponentially in men after their late 50s, and studies indicate that 30 percent of males worldwide between the ages of 40 and 70 experience some form of erectile dysfunction. As the population of the United States and other developed countries ages, the proportion of men affected by erectile dysfunction should increase and it is estimated that by the year 2000, 47 million men worldwide will be affected.
Abstract Presented by Dr. Harin Padma-Nathan
at the Western Section of the American Urological Association Annual Meeting
July 31, 1996
RESTORATION OF ERECTILE FUNCTION BY TRANSURETHRAL ALPROSTADIL IMPROVES THE QUALITY OF LIFE FOR PATIENTS AND THEIR PARTNERS. Harin Padma-Nathan, Ronald G. Anderson, Stanley A. Brosman, Robert G. Ferrigni, Fred E. Govier, Richard F. Labasky, Tom F. Lue, Ira D. Sharlip, Gary M. Stack, Emil A. Tanagho, Jay M. Young, Christy Cowley, Neil Gesundheit, Craig A. Peterson, Alfred P. Spivack, Darby E. Stephens, Peter Y. Tam, Virgil A. Place, and the VIVUS-MUSE Study Group, Menlo Park, CA.
Previous studies have shown that alprostadil, delivered transurethrally, can restore erections and sexual intercourse in many men with chronic erectile dysfunction. We have now studied the effect of treatment and restoration of sexual function on Quality of Life in couples during a three-month, double-blind, placebo-controlled trial.
Methods. We studied 996 adult men (age: 30-84; mean 62) with chronic organic erectile dysfunction (mean duration: 48 months) who were in a stable, heterosexual, monogamous relationship and responded adequately to transurethral alprostadil during in-clinic titration. Patients were randomized to home therapy for three months with either active drug (at their titrated dose) or placebo (double-blind). Patients and partners each completed Quality of Life questionnaires before, during, and after the study. Participants indicated their response to each question on a 0-100 scale. The questionnaire included questions about anxiety, self-esteem, and mood (depression), which were analyzed as an "Emotional Well-Being" domain. Questions about the couple's sexual and nonsexual relationship were analyzed as a "Relationship With Partner" domain.
Results. All couples had been unable to engage in sexual intercourse for at least 3 months preceding enrollment. During home treatment, 64.9% of patients on alprostadil vs. 18.6% of those on placebo reported intercourse at least once (p < 0.001). Couples randomized to active drug or placebo had comparable Quality of Life scores at baseline. In patients who responded to active medication, there was a significant improvement in the "Emotional Well-Being" domain compared to those on placebo (p < 0.004). Similarly, there was a significant improvement in the "Relationship With Partner" domain for responders and for partners of responders compared to placebo (p < 0.001 for each). There was no change in either the active or placebo group in the "Emotional Well-Being" domain of the partner.
Summary. Restoration of sexual intercourse by transurethral alprostadil is associated with improvement in several important Quality of Life domains: "Emotional Well-Being" for patients and "Relationship With Partner" for both the patient and his partner.
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Too bad there are no comparable data about Viagra yet. Especially in the severe organic class. I hate to dredge data, but as an aside, I find it interesting that, even in this study group, there was an 18.6% placebo response. So that might mean that "anything" will have a effect on one-fifth of the patients. The placebo response is the stuff that keeps quackery thriving.
Zebra |
