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| |  AUA MEETING: No Link Between Sex And Death For Men Taking Muse DALLAS, TX -- May 4, 1999 -- A new, multinational study has found no link between renewed sexual activity and an increase in cardiovascular risk or death for men using Janssen-Ortho Inc.'s Muse(R) (alprostadil) micro-suppository, a treatment for erectile dysfunction. Researchers, who presented the results at the American Urological Association meeting today, decided to undertake the study when reports began to surface about the safety of impotence treatments, renewed sexual activity and the association with cardiac mortality or morbidity. "With impotence's recent gain in notoriety, speculation had suggested that there was a link between sexual activity and coronary events," said Dr. Robert Nelson, professor of urology and chief of andrology at the Medical University of South Carolina, who presented the results today. "As physicians, we were concerned that undue alarm about sex was being created and that the proper message wasn't being formulated for the public. "Recent research had already indicated that the link between sex and cardiac morbidity didn't exist. But the new variable in the mix was impotence therapy, so we decided to see if it played a role. For men treated with Muse it did not." The double-blind, placebo-controlled trial was the largest prospective study of its kind and included 1,156 patients, 30 per cent of which had cardiovascular disease as an underlying medical condition. "Despite the fact that 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 Muse did not increase the risk," Dr. Nelson explained. All patients enrolled in the study suffered from severe, organic erectile dysfunction for an average of four years and no participants had the ability to experience sexual intercourse for at least three months prior to entering the study. Half the patients were treated with Muse and the remaining received placebo. Over the three-month treatment period, patients treated with Muse had over five times as many occurrences of sexual intercourse (2,875 versus 500) but only half as many cardiac events as patients on placebo (five versus 10). There were no cardiac-related deaths in either group. Opinions on sexual activity in cardiovascular patients were stated in an Expert Consensus Document produced jointly by the American Heart Association and the American College of Cardiology, and published in the Journal of the American College of Cardiology earlier this year. The authors noted that sexual activity triggering death or acting as a likely contributor to a heart attack is extremely low (less than one per cent). In fact, they found that the relative risk of myocardial infarction is not increased in patients with a prior history of cardiac disease and that regular exercise appears to prevent triggering. "The paper from the College of Cardiology and the experiences with [Pfizer Inc.’s] Viagra to date, strongly support the notion that the safety of each treatment needs to be considered separately," Dr. Nelson said. "While Viagra is a good treatment option, its use in patients with cardiac issues is not without concern." Related Links: Muse, Janssen-Ortho Inc.
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