FDAnews Drug Daily Bulletin

STUDY: LEVITRA EFFECTIVE IN MEN TAKING BLOOD PRESSURE DRUGS

March 31, 2006
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A clinical study has found GlaxoSmithKline (GSK) and Schering-Plough's erectile dysfunction (ED) drug Levitra is effective in men taking high blood pressure drugs, the firms announced.

According to data published in the Journal of Sexual Medicine, patients treated with Levitra (vardenafil HCl), a PDE5 inhibitor, experienced an 83 percent overall success rate in erectile function while also receiving one or more antihypertensive drugs.

"This study demonstrated that Levitra was well-tolerated when used concomitantly with antihypertensive medications in patients not previously treated with PDE5 inhibitors," said study author Hermann van Ahlen of the University of Münster in Germany.

Hypertension is a major risk factor for ED and affects 29.4 million men in the U.S., according to the firms. Many blood-pressure-lowering drugs may adversely affect erectile function, the companies added.

The study gave either Levitra or a placebo to 354 men who were taking hypertension drugs -- not including alpha blockers -- and had experienced ED for more than 6 months. In the Levitra group, 83 percent of men reported having an erection compared to 58 percent of men taking the placebo.