Results of the first prospective trial specifically designed to evaluate erectile function in erectile dysfunction (ED) patients with dyslipidemia show that LEVITRA (vardenafil HCl), used in treating ED, significantly improves the ability of men with ED and dyslipidemia to achieve and maintain an erection for successful sexual intercourse. These data were presented at the Sexual Medicine Society of North America (SMSNA) Fall Meeting held in Chicago, IL.
The double-blind, placebo-controlled study is the first study to measure the safety and efficacy of a PDE 5 inhibitor in a cohort of men who all had ED and dyslipidemia. Results from the study of 395 men show that LEVITRA significantly increased rates of penetration (as measured by SEP2 scores) and the ability to maintain an erection (as measured by SEP3 scores) compared to placebo.
"ED is associated with high cholesterol, yet many physicians are not treating ED, a life-changing condition," said Dr. Martin Miner, Clinical Associate Professor of Family Medicine at Brown University's Warren Alpert School of Medicine. "This study provides further support that LEVITRA can successfully treat ED, even in men with a serious common condition like high cholesterol."
Nearly 70 percent of the estimated 30 million men in the United States who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction. Previous studies have demonstrated the efficacy and safety of LEVITRA in men with ED who also have high blood pressure or diabetes.
About the Study
In the double-blind, placebo-controlled study, 395 men ages 18 to 64 that had ED and dyslipidemia were randomized to treatment with LEVITRA or placebo for 12 weeks.
Men treated with LEVITRA had statistically significant and clinically relevant improvements in SEP2 scores (a rating system that measures penetration) and SEP3 scores (a rating system that measures maintenance of erection) versus placebo (79.1% and 66.7%, respectively, for LEVITRA, vs. 51.9% and 33.8%, respectively, for placebo). IIEF-EF (International Index of Erectile Function) scores also were significantly higher for the LEVITRA group compared to the placebo group. These scores are evaluated based on a patient questionnaire and their daily diary response to specific questions about sexual performance.
LEVITRA was well tolerated. Treatment-emergent adverse effects (occurring in = 5% of patients) included headaches (9% for LEVITRA, 1% for placebo) and upper respiratory tract infections (5% for LEVITRA, 3% for placebo).