Daily tadalafil: efficacy and safety of a new dosing regimen

Abstract

Tadalafil is a selective, reversible phosphodiesterase type 5 inhibitor with demonstrated efficacy as an oral treatment for erectile dysfunction (ED). The molecule possesses a favourable pharmacokinetic profile, with a rapid onset of action and prolonged duration of proerectile effects. The pharmacokinetics characteristics of tadalafil are amenable to once-a-day dosing, which may be an attractive alternative treatment for patients with ED. Two randomized, placebo-controlled, double-blind studies in men with ED showed that 2.5-10 mg tadalafil once daily significantly improved erectile function compared with placebo, after 12 or 24 weeks. In two open-label extensions of these studies, the efficacy of tadalafil was maintained over a two year treatment period, suggesting lack of tolerance. In terms of safety, tadalafil administered daily was well tolerated, did not affect cardiovascular safety, and demonstrated lack of toxicity on spermatogenesis.