Safety and efficacy of the combination of once-daily tadalafil and alpha-1 blocker in Japanese men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: A randomized, placebo-controlled, cross-over study
Abstract
OBJECTIVES: To evaluate the safety and efficacy of tadalafil plus α1 -blocker combination therapy in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
METHODS: The present multicenter, randomized, double-blind, placebo-controlled, two-period cross-over study compared the effects of tadalafil and a placebo added to ongoing α1 -blocker therapy. A total of 171 Japanese patients were randomized.
RESULTS: Tadalafil combined with an α1 -blocker did not decrease blood pressure in the orthostatic test. The only statistically significant differences in vital signs between the combination and monotherapy groups were diastolic blood pressure and pulse (P = 0.0194 and 0.0313, respectively). However, these changes were not considered clinically meaningful. Treatment-related adverse events occurred in 28.1% (47/167) and 24.2% (39/161) of patients in the combination therapy and α1 -blocker monotherapy groups, respectively. Additionally, 56.7% (89/157) of patients preferred combination therapy to monotherapy, though this was not statistically significant (P = 0.0937). There was a statistically significant reduction in the International Prostate Symptom Score voiding subscore in the combination therapy group (P = 0.0442).
CONCLUSIONS: Concurrent treatment with tadalafil and an α1 -blocker seems to be safe and well tolerated in Japanese patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Adding tadalafil to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 171 participants or records.
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