Tadalafil: in the treatment of signs and symptoms of benign prostatic hyperplasia with or without erectile dysfunction.

Tadalafil is a selective cyclic guanosine monophosphate-specific phosphodiesterase type 5 inhibitor. Once-daily tadalafil 5 mg was effective in treating the signs and symptoms of benign prostatic hyperplasia (BPH). In phase III trials in men with BPH, the mean change from baseline to week 12 in the total International Prostate Symptom Score (IPSS; primary endpoint) was significantly greater in those treated with once-daily tadalafil 5 mg than with placebo. Improvements in total IPSS that occurred over the initial 12 weeks of tadalafil treatment were maintained with continued treatment over a 1-year period in an open-label extension study. Moreover, tadalafil was effective in treating both erectile dysfunction (ED) and the signs and symptoms of BPH in a phase III trial that specifically enrolled men with both indications. Both the International Index of Erectile Function-Erectile Function domain score and the total IPSS (co-primary endpoints) were significantly improved from baseline to week 12 after treatment with once-daily tadalafil 5 mg compared with placebo. Tadalafil was generally well tolerated (for a period of up to 1 year) in patients with BPH, including those with ED, with adverse events being of mild to moderate intensity.