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 erectile dysfunction (ED) and dyslipidemia. In the double-blind, placebo-controlled study, 395 men aged 18 to 64 and 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, versus 51.9% and 33.8%, respectively, for placebo). 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).
Martin Miner, clinical associate professor of family medicine at Brown University’s Warren Alpert School of Medicine, said: “This study provides further support that Levitra can successfully treat ED, even in men with a serious common condition like high cholesterol.”