Daily tadalafil may relieve urinary symptoms in men with BPH

September 11, 2008

A daily dose of tadalafil (Cialis) may relieve lower urinary tract symptoms in men with BPH symptoms, according to a study published in the Aug. 21 online edition of The Journal of Urology.

A daily dose of tadalafil (Cialis) may relieve lower urinary tract symptoms in men with BPH symptoms, according to a study published in the Aug. 21 online edition of The Journal of Urology.

“Since reports of ED incidence, pathophysiology, and treatment have shown a possible link between BPH LUTS and ED, PDE-5 inhibitors like tadalafil have received increased attention for treating BPH LUTS, although they are currently only approved for ED,” said lead study author Claus G. Roehrborn, MD,of the University of Texas Southwestern Medical Center in Dallas.

“The half-life of tadalafil is 17.5 hours, making it suitable as once-daily therapy. Although the precise mechanism of action by which PDE-5 inhibitors may alleviate LUTS is not completely understood, several putative mechanisms are currently under investigation.”

Participants in the tadalafil study were required to have at least a 6-month history of LUTS secondary to BPH. Men with a PSA >10 ng/mL were excluded, as were those with other complicating conditions or conflicting drug treatments. Men who had undergone treatment for ED or other BPH treatments underwent a 4-week treatment-free screening period. All participants then received placebo for 4 weeks prior to randomization. The 1,056 subjects were then divided randomly into five groups who received either a placebo or doses of 2.5, 5.0, 10.0, or 20.0 mg/day of tadalafil.

Using the International Prostate Symptom Score, the team found that all doses of tadalafil were superior to placebo for relieving LUTS, with statistically significant effects at 4, 8, and 12 weeks. The treatments decreased IPSS scores from 3.9 to 5.2 points in the various dosage groups, a clinically meaningful improvement, according to the guidelines of AUA. Of the doses studied, 5 mg per day improved the IPSS by 4.9 points and provided the best risk-benefit profile.