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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: DaiS who wrote (9308)	6/8/1998 1:19:00 AM
From: Zebra 365	Read Replies (1) \| Respond to of 23519

Quality of Life measures with MUSE DaiS, Actually I was thinking of a Quality of life study presented below. This came out of the same study as the 1997 NEJM but was not published with it. My point was not to criticize you but to point out that a rapist is a rapist, and having a medicine that causes erections is unlikely to lead to more rapes. 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. Quality of Life Domains Baseline Final p-value Emotional Well-Being of Patients Active Drug (Responders) 64.8 68.6 < 0.004 Placebo 65.7 66.9 Patient's Relationship with Partner Active Drug (Responders) 58.6 63.8 < 0.001 Placebo 58.1 56.0 Partner's Relationship with Patients Active Drug (Responders) 56.4 62.7 < 0.001 Placebo 55.9 54.6 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. Zebra A couple more "real" investigations that were published in peer reviewed journals to follow.