Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a 1-year, open-label extension study
Abstract
Study Type – Therapy (cohort) Level of Evidence 2b What’s known on the subject? and What does the study add? Phosphodiesterase type‐5 (PDE5) inhibitors (tadalafil, vardenafil, and sildenafil) are well‐known treatment options for men with erectile dysfunction and should be taken before anticipated sexual activity. Tadalafil is also approved for once daily use in men with erectile dysfunction. Recent 12‐week studies in men with benign prostatic hyperplasia (BPH) have shown once daily use of tadalafil significantly reduced their urinary symptoms. This article is the first to report the long‐term safety and maintenance of efficacy for once‐daily use of tadalafil in men with urinary symptoms secondary to BPH. OBJECTIVE • To evaluate the 1‐year safety of 5 mg of tadalafil once daily in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH‐LUTS); efficacy measures were included to evaluate the maintenance of efficacy after an additional year of treatment. PATIENTS AND METHODS • In total, 427 men who completed a 12‐week, placebo‐controlled, dose‐ finding study assessing once‐daily tadalafil (2.5, 5, 10 or 20 mg) or placebo elected to continue into the open‐label extension period. Safety and efficacy parameters were assessed after 1 month and every 3 months. RESULTS • In total, 299 patients (69.9%) completed the 1‐year, open‐label extension period. Treatment‐emergent adverse events (TEAEs) were reported by 57.6% of patients, with most TEAEs being mild…
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: 427 participants or records.
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