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| |  Restoring Sexual Activity With Muse Does Not Increase Cardiac Morbidity, Mortality MOUNTAIN VIEW, CA -- April 13, 1999 -- An abstract, presented at the 14th congress of the European Association of Urology in Stockholm, Sweden, shows that restoring sexual activity with Vivus Inc.’s Muse(R) (alprostadil) does not increase cardiac morbidity or mortality. The abstract was presented by co-author Gordon Williams, MD, consultant urologist at the Hammersmith Hospital, London. "Although many of the patients in the Muse studies were already at risk for cardiac events given their history of vascular disease, resuming sexual relations with the use of Muse did not increase the risk,” Dr. Williams said. “This study has clearly shown that restoring sexual activity with Muse does not increase cardiac morbidity or mortality. In fact, several published studies have shown that sexual intercourse is good for you and reduces the risk of a heart attack. "Safety issues associated with the treatment of erectile dysfunction need to be addressed separately for each of the available treatments." Dr. Williams reported results of multinational studies that enrolled 1,156 patients suffering from severe, organic erectile dysfunction (ED) for an average of four years. No participants had the ability to experience sexual intercourse for at least three months prior to entering the study. Vascular disease or diabetes was present in more than half of the patients. The clinical trials were double-blind, placebo-controlled with half the patients treated with Muse and the remaining patients receiving placebo. Over the three-month treatment period, patients treated with Muse had over five times as many occurrences of sexual intercourse but only half as many cardiac events as patients on placebo. Since the approval of the product in November 1996, over 1.2 million prescriptions for Muse have been filled. Post-approval safety reporting and surveillance have identified only one death reported to the FDA associated with the use of Muse as the patient's sole ED therapy. Muse therapy consists of a proprietary, non-invasive drug delivery system that delivers pharmacological agents via the urethra. Muse is not for men with sickle cell trait, disease, or other blood disorders. One third of men reported genital pain, causing some to stop use. A few men reported dizziness and, less commonly, fainting. Related Links: Muse, Vivus Inc.
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