Study Confirms That Levitra® On Demand Is Effective In Patients With ED After Nerve-sparing Prostatectomy

A study published in the European Urology journal demonstrated that Levitra® (vardenafil, HCI) is highly efficacious in men with erectile dysfunction (ED) even shortly after radical nerve-sparing prostatectomy. This landmark study conducted by Bayer Schering Pharma was a double-blind, randomized, placebo-controlled multicentre study, the largest of its kind until. It investigated the tolerability and efficacy of Levitra taken once nightly as a prophylactic treatment versus Levitra PRN taken on demand (i.e. when needed) versus placebo after a bilateral, nerve-sparing, radical retropubic prostatectomy (BNSRRP).In the first, double-blind phase of the study, which started approximately 14 days after surgery and ended nine months later, men experienced excellent results with Levitra. 36 percent of men taking Levitra on demand (on demand vs. placebo p=<0.0001), 20 percent taking Levitra nightly (p=<0.01) and 17 percent of men on placebo reported normal erectile function (represented by an International Index of Erectile Function (IIEF) of ≥ 26) measured at last observation carried forward (LOCF). Over the entire double-blind period the mean per-patient success rates for a successful intercourse were 46 percent for Levitra on demand (vs. placebo p=<0.0001), 34.5 percent for Levitra nightly, and 25 percent on placebo as measured by one question of the diary-based Sexual Encounter Profile (SEP). The study does not support its primary endpoint, the concept of maintaining erectile function by an early intervention with nightly dosing of Levitra in patients after nerve-sparing prostatectomy.....

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