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Title: Tadalafil May Relieve LUTS in Benign Prostatic Hyperplasia

"Tadalafil May Relieve LUTS in Benign Prostatic Hyperplasia"

NEW YORK -- August 19, 2008 -- According to a study appearing in the October 2008 issue of the[ Journal of Urology, a daily dose of tadalafil may relieve lower urinary tract symptoms (LUTS) in men with signs of benign prostatic hyperplasia (BPH).

Study researchers reported on a randomised, double-blind, placebo-controlled study of more than 1,000 men in 10 countries.

Participants were required to have at least a 6-month history of LUTS secondary to BPH. Those with a high prostate specific antigen (>10 ng/mL) were excluded as well as those with other complicating conditions or conflicting drug treatments.

Anyone who had undergone treatment for erectile dysfunction (ED) or other BPH treatments underwent a 4-week treatment-free screening period. All participants then received placebo for 4 weeks prior to randomisation. The 1,056 subjects were then divided randomly into 5 groups that received placebo or tadalafil 2.5, 5.0, 10.0, or 20.0 mg/day.

According to the International Prostate Symptom Score (I-PSS), all doses of tadalafil were superior to placebo for relieving LUTS, with statistically significant effects at 4, 8, and 12 weeks. The treatments decreased I-PSS scores in the different dosage groups, yielding a clinically meaningful improvement. Of the doses studied, 5 mg per day improved the I-PSS by 4.9 points and provided the best risk-benefit profile.

"Since reports of ED incidence, pathophysiology, and treatment have shown a possible link between BPH LUTS and ED, [phosphodiesterase type 5 (PDE5)] inhibitors like tadalafil have received increased attention for treating BPH LUTS, although they are currently only approved for ED," stated Claus G. Roehrborn, MD, University of Texas Southwestern Medical Center, Dallas, Texas. "The half-life of tadalafil is 17.5 hours, making it suitable as once-daily therapy.

"Although the precise mechanism of action by which PDE5 inhibitors may alleviate LUTS is not completely understood," Dr. Roehrborn continued, "several putative mechanisms are currently under investigation."

SOURCE: Journal of Urology

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