BPH scores improved by PDE-5 inhibitor, alpha-blocker

Both the phosphodiesterase-type-5 inhibitor tadalafil (Cialis) and alpha-blocker tamsulosin (Flomax) appear to significantly improve scores on the International Prostate Symptom Score (IPSS) compared with placebo in men with signs and symptoms suggestive of BPH.

Tadalafil also improved erectile dysfunction in men who had both signs and symptoms of BPH and erectile dysfunction, according to a study that was published online in European Urology (Jan. 20, 2012).

The study also showed that maximum urinary flow rate increased significantly versus placebo with both tadalafil and tamsulosin.

First author Matthias Oelke, MD, of Hannover Medical School, Hannover, Germany, and co-authors conducted a randomized, double-blind, placebo-controlled 12-week trial in 44 urology centers in 10 countries to assess the efficacy and safety of tadalafil, 5 mg for daily use, in parallel with tamsulosin, 0.4 mg, in men age 45 years and older with signs and symptoms of BPH.

The primary measure was the IPSS. The key secondary measure was the BPH Impact Index (BII). In addition, the International Index of Erectile Function-Erectile Function (IIEF-EF) domain was measured in subjects who had both ED and signs and symptoms of BPH.

Tadalafil met the primary endpoint, significantly improving IPSS total scores through 12 weeks versus placebo (–2.1; p=.001). Tamsulosin also significantly improved IPSS total scores through 12 weeks versus placebo (–1.5; p=.023). After 4 weeks, BII significantly improved with tadalafil versus placebo (–0.8; ppp=.003; tamsulosin –0.6, p=.026). The IIEF-EF domain improved with tadalafil versus placebo (4.0; pp=.699).

Tadalafil showed significant improvement in signs and symptoms of BPH after 1 week and a significant increase in maximum urinary flow rate (Qmax) at 12 weeks. Both treatments significantly improved total IPSS as early as 1 week (tadalafil and tamsulosin both –1.5; pp=.009) and tamsulosin (2.2 ml/s; p=.014).

Dr. Oelke has received honoraria from Astellas, GlaxoSmithKline, Eli Lilly and Co., and Merckle-Recordati. His co-authors are consultant/lecturers or employees/stockholders of Eli Lilly and Co.

Go back to this issue of Urology Times eNews.