Tadalafil 5 mg Once Daily Improves Lower Urinary Tract Symptoms and Erectile Dysfunction: A Systematic Review and Meta-analysis.

OBJECTIVES: We carried out a systematic review and meta-analysis to assess tadalafil 5 mg once-daily for the treatment of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED).

METHODS: A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of tadalafil 5 mg once-daily for the treatment of LUTS and ED. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated.

RESULTS: Thirteen publications involving a total of 3973 patients were used in the analysis, including 13 RCTs that compared tadalafil 5 mg once-daily with placebo. We found that tadalafil 5 mg once-daily was effective in improving LUTS suggestive of BPH and treating ED over 12 weeks in our meta-analysis. Total International Prostate Symptom Score (IPSS) (SMD = - 2.02, 95% CI = - 2.52 to -1.53, P < 0.00001); Benign Prostatic Hyperplasia Impact Index (BPH-II) (SMD = -0.58, 95% CI = -0.84 to -0.33, P < 0.00001); International Index of Erectile Function-erectile function (IIEF) domain (standardized mean difference [SMD] = 5.18, 95% confidence interval [CI] = 4.13-6.23, P < 0.00001) indicated that tadalafil 5 mg once-daily was more effective than the placebo. Safety assessments included discontinuations due to adverse event (odds ratio (OR) = 1.79, 95% CI = 1.12-2.85, P = 0.01) indicated that tadalafil 5 mg once-daily was well tolerated.

CONCLUSIONS: This meta-analysis indicates that tadalafil 5 mg once-daily to be an effective treatment for LUTS and ED with a low occurrence of side effects.