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| |  Vardenafil Data Reports Positive Results In Erectile Function WEST HAVEN, CT -- December 7, 2001 -- Results of the first pivotal phase III data released on vardenafil, an investigational phosphodiesterase-5 (PDE-5) inhibitor, found up to 85 percent reported improvement across a broad population of patients with erectile dysfunction (ED). These findings were presented today at a press conference at the 2001 Annual Meeting of the Sexual Medicine Society of North America (SMSNA), held in Charleston, South Carolina. "The pivotal phase III data show vardenafil consistently achieves positive responses across a broad range of patients with erectile dysfunction, regardless of the cause or severity of the disorder," said Wayne J.G. Hellstrom, M.D., chief specialist in the treatment of male erectile dysfunction and infertility at Tulane University School of Medicine, New Orleans, and lead investigator of the study. This double-blind, placebo-controlled study involved 736 patients over age 18 with varied ED severities (mild to severe) and causes (organic and psychogenic conditions). Patients were randomized into four groups and received an oral tablet of 5 mg, 10 mg, or 20 mg of vardenafil, or placebo to be taken on demand. The study population also included patients with underlying conditions, such as hypertension, diabetes, and enlarged prostate (non-cancerous). Study participants all had experienced erectile difficulties for at least six months. Patients were evaluated at 12 weeks and again at 26 weeks by the General Assessment Question (GAQ), a standard question used in all clinical trials for erectile function. The question reads: "Has the treatment you have been taking over the past four weeks improved your erections?" At 26 weeks, patients reported an 85 percent improvement in erections at the 20 mg dose, as assessed by the GAQ, compared with 28 percent for patients taking placebo (p<0.0001). Men in the 10 mg and 5 mg groups also reported statistically significant improvements in erectile function of 80 and 65 percent, respectively. Side effects were generally mild to moderate and transient in nature. The most common side effects were headache, upset stomach, vasodilation, rhinitis, and sinusitis. ED is a largely untreated medical condition Erectile dysfunction -- the inability to sustain an erection sufficient for sexual intercourse -- is a major medical condition among men that is largely untreated. Although ED affects an estimated 30 million men in the United States(1), research shows only 11 percent of men are being treated for the condition(2). There are a number of causes for ED, including medical conditions, such as diabetes and cardiovascular disease, as well as psychological factors. "With such a large segment of this population not seeking treatment, there is an opportunity for additional therapies for this medical condition," said Nancy Bryan, vice president, Marketing in Men's Health, Bayer Corporation. "The findings from this pivotal phase III study suggest vardenafil may be an important option to help improve erectile function among a wide variety of men with ED." A new drug application for vardenafil was submitted and accepted for filing by the U. S. Food and Drug Administration (FDA). Bayer AG recently announced a worldwide co-promotion agreement with GlaxoSmithKline plc for vardenafil, further reinforcing the commitment to bring this treatment to market successfully. References SOURCE: Bayer Corporation
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