PDE-5 inhibitor approved to treat men with both BPH and ED

Eli Lilly and Co. has announced that the FDA has approved the phosphodiesterase type-5 inhibitor tadalafil (Cialis) for once-daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of BPH.

The FDA also approved tadalafil for once-daily use for a separate indication for the treatment of the signs and symptoms of BPH.

The new indications are based on a clinical trial program of three placebo-controlled efficacy and safety studies that included 1,989 men (see below). Two of these studies were in men with BPH and one study was specific to men with both ED and BPH. In the ED+BPH study, tadalafil, 5 mg for once-daily use, significantly improved scores on the International Index of Erectile Function-Erectile Function (IIEF-EF) domain and the International Prostate Symptom Score (IPSS).

"Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians," said Claus Roehrborn, MD, of the University of Texas Southwestern Medical Center, Dallas. "The FDA approval of tadalafil for once-daily use for the treatment of ED and the signs and symptoms of BPH provides a new option that allows men to treat both with one daily medication."

Results from one of the phase III studies was published online in the Journal of Sexual Medicine (Oct. 7, 2011). The authors found that tadalafil, 5 mg tablets for once-daily use met its co-primary endpoints, significantly improving measures of both ED and signs and symptoms of BPH in men with both conditions.

The randomized, double-blind, placebo-controlled, parallel-design clinical study, conducted in 54 urology centers in nine countries, assessed the safety and efficacy of tadalafil, 2.5 or 5 mg for once-daily use in 606 sexually active men aged 45 years and older who had experienced ED for at least 3 months and BPH symptoms for more than 6 months. The men were randomly assigned to receive placebo; tadalafil, 2.5 mg; or tadalafil, 5 mg in a 1:1:1 ratio for a period of 12 weeks.

Tadalafil, 5 mg, significantly improved the mean differences from baseline on IIEF-EF domain scores and IPSS scores through 12 weeks versus placebo (4.7 and –2.3, respectively, both ppp=.18).

On the key secondary measures, the mean differences from baseline with tadalafil, 5 mg, compared with placebo after 12 weeks were 19.7% (pppp=.16).

Dr. Roehrborn is a consultant/adviser and investigator for Eli Lilly.

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