Study shows reliable improvement in erectile function over time.

In the first study, men with erectile dysfunction (ED) who were taking the oral investigational drug Levitra™ reported consistently improved erectile function the first time they took the drug and subsequently thereafter. For the three months of the study involving more than 800 ED patients, Levitra™ was reported to consistently improve rates of successful penetration, intercourse success and overall satisfaction during the first and subsequent attempts.1 Investigators evaluated the ability of Levitra™ to provide reliable efficacy over time in a broad population of men with ED. They analyzed data from a phase III, randomized, double-blind study in which 805 men, including 100 Canadian men with ED and 11 Canadian trial sites, received Levitra™ 5, 10 or 20 mg or placebo for up to 26 weeks.

The analysis showed that at a 20 mg dose: On average men were successful in 74 per cent of their first attempts in penetrating their partner compared with 46 per cent of men taking placebo. Of those men taking Levitra™ who were successful the first time, they continued to achieve successful penetration in 91 per cent of subsequent attempts.1 “Men want to be confident that the ED drug they are taking works the first time and time after time,” said Dr. Luc Valiquette, Professor of Urology at the Hospital Saint-Luc du CHUM in Montreal, Quebec. “I’ve seen frustration in some of my patients because the current treatments do not consistently work, and their efficacy may diminish over time. This reinforces the need for new oral ED therapies that are effective, consistent and safe.”

Study shows improvement in erection quality following prostate cancer surgery
In another study – the first of its kind to assess the effect of a phosphodiesterase (PDE-5) inhibitor on erectile function and depressive symptoms among men with ED resulting from prostate cancer surgery – men taking Levitra™ were more likely to report improved erections and fewer depressive symptoms than men taking placebo.2 In this phase III clinical trial, 440 men aged 44 to 77 years with ED following prostatectomy and who experienced ED for six months before entering the study, were randomly assigned to placebo or Levitra™ (at a dose of 10 or 20 mg) for 12 weeks. This study included 24 Canadian trial sites with 176 patients.

After 12 weeks: Up to 71 per cent of patients who had undergone a specific type of prostatectomy, known as bilateral nerve-sparing prostatectomy, reported statistically significant improvement in erections with Levitra™ 20 mg versus 12 per cent of men taking placebo. A significant decrease in depressive symptoms was observed among a small subset of depressive prostatectomy patients taking Levitra™ 20 mg. “Men who suffer from ED following prostatectomy are among the most difficult to treat because their ED is typically severe.

The finding that Levitra™ significantly improved erectile function in our study-patients is important because more than two-thirds of these men had severe ED,” said Dr. Gerald Brock, lead study investigator and Associate Professor, Department of Surgery, Division of Urology at St. Joseph’s Health Centre in London, Ontario. He also added: “The finding that Levitra™ eased depressive symptoms in these men is very good news, because it means that Levitra™ helps improve quality of life in men who are often suffering both emotionally and physically from this condition.” In these studies, drug-related adverse events were reported as generally mild to moderate in intensity with the most frequent adverse events being headache, flushing and rhinitis.

ED – the persistent inability to attain and maintain an erection adequate to permit satisfactory sexual intercourse – is a common health condition among men that is largely untreated. It is estimated that some degree of ED affects more than one half of all men over the age of 40.3 Worldwide, an estimated 152 million men4 and three to four million Canadian men5 suffer from ED. Levitra™, researched and discovered by Bayer, will be marketed by Bayer and GlaxoSmithKline (GSK) through a worldwide co-promotion and co-development agreement that the two companies signed in November 2001. Marketing Authorization Applications have been approved by regulatory authorities in several Latin American countries and have been submitted for regulatory review in all major regions worldwide, including Canada, the United States, Europe and Japan.