Efficacy and safety of tadalafil in men with erectile dysfunction with and without hypertension
Abstract
Hypertension, both treated and untreated, has been associated with erectile dysfunction (ED). In the Massachusetts Male Aging Study, the age-adjusted probability for complete ED in men with treated hypertension was 14% vs 9.6% in the entire sample of 1290 men aged 40 to 70 (Feldman et al. N Engl J Med. 1994;151:54-61). Tadalafil is a selective and potent inhibitor of phosphodiesterase type 5, for the treatment of men with erectile dysfunction. In clinical trials, tadalafil has been shown to enable men with ED to achieve and maintain an erection sufficient for successful intercourse in the presence of sexual stimulation. This integrated analysis was undertaken to assess the efficacy and safety of tadalafil. Tadalafil doses 2.5 to 20 mg, taken as needed (maximum, once daily), were evaluated in 1112 men (mean age, 58 years; range, 21-82 years) in four 12-week (n=972) and one 24-week (n=140) randomized, double-blind, placebo-controlled phase 3 trials. Patients were free to choose the timing of sexual attempts after dosing. There were no restrictions on food and alcohol intake. Treatment effects were evaluated via the International Index of Erectile Function, Sexual Encounter Profile diaries, and Global Assessment Question, all of which are self-administered. Tadalafil significantly improved all primary and secondary endpoints vs placebo. Up to 81% of tadalafil-treated men (from the 12-week studies) reported improved erections. The mean percentage of successful intercourse…
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: 1,290 participants or records.
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