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

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Urology / Nephrology;  Men's health;  Clinical Trials / Drug Trials
Article Date: 26 Jul 2008 - 1:00 PDT

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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."

These new study data confirm the well-established efficacy of Levitra in patients after a radical prostatectomy and reassures doctors and patients that Levitra taken on demand, i.e. when sexual intercourse is planned, is the optimal treatment for this condition and that a daily / nightly prophylactic use of PDE5 (phopsodiesterase type 5) inhibitors is not indicated. The study was conducted at 87 centers across Europe, Canada, North America and South Africa, and investigated 445 males aged 18 up to 64 for up to 13 months.

About BNSRRP

The nerve-sparing radical prostatectomy technique used for prostate cancer has been evolving continuously. However, the risk of developing ED, a side effect of the procedure, has remained significant. ED is a major drawback of this surgical procedure and occurs in the majority of men who were sexually active prior to surgery.

About Erectile Dysfunction

Levitra has shown in many studies to be effective in men with a wide range of underlying conditions such as hypertension, diabetes, obesity and dyslipidemia. It provides a rapid and effective solution to ED in a broad patient population and enables both partners to achieve sexual satisfaction. Levitra is a potent PDE5 inhibitor which has shown high levels of efficacy and tolerability in patients with ED, including post-radical-prostatectomy patients.

About Bayer

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.

About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare.

With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.

Forward Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at http://www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.