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.
"The results show that Levitra taken on demand effectively treats erectile dysfunction immediately, and reliably after prostatectomy and helps restore the man," said lead investigator, Professor Francesco Montorsi from the University Vita Salute San Raffaele, Milan, Italy. "For men with ED caused by radical prostatectomy, this study will finally shed light on the most efficient way to use PDE5 inhibitors after this type of surgery."
Remainder of article can be found at Medical News Today



