Tadalafil 2.5 or 5 mg Administered Once Daily for 12 Weeks in Men with Both Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia: Results of a Randomized, Placebo‐Controlled, Double‐Blind Study

ABSTRACTIntroductionErectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH‐LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH‐LUTS.AimsThis multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH‐LUTS in men with both conditions during 12 weeks of double‐blinded therapy.MethodsMen were ≥45 years old, sexually active, and experiencing ED for ≥3 months and BPH‐LUTS for >6 months. Randomization (baseline) followed a 4‐week placebo lead‐in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co‐primary and key secondary measures at end point (last post‐baseline observation).Main Outcome MeasuresThe co‐primary measures were the International Index of Erectile Function‐erectile function (IIEF‐EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment‐emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed.ResultsTadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF‐EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least‐squares mean ± standard error change from baseline at end point, placebo −3.8 ± 0.5, tadalafil 2.5 mg −4.6 ± 0.4, and 5 mg −6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters.ConclusionsTadalafil 5 mg significantly improved both ED and BPH‐related outcomes through 12 weeks and was well tolerated. Egerdie RB, Auerbach S, Roehrborn CG, Costa P, Garza MS, Esler AL, Wong DG, and Secrest RJ. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: Results of a randomized, placebo‐controlled, double‐blind study. J Sex Med 2012;9:271–281.