OBJECTIVE To provide an update on the efficacy and safety of tadalafil, a phosphodiesterase‐5 inhibitor, in the treatment of erectile dysfunction (ED). PATIENTS AND METHODS In all, 2102 men (mean age 56 years) with mild‐to‐severe ED of various causes were randomized to placebo or tadalafil, taken as needed with no food restrictions, at fixed ‘on‐demand’ doses of 10 or 20 mg in 11 randomized, double‐blind, placebo‐controlled trials lasting 12 weeks. The three co‐primary outcomes were changes from baseline in the erectile function domain of the International Index of Erectile Function (IIEF) and the proportion of ‘yes’ responses to questions 2 and 3 of the Sexual Encounter Profile (SEP). Additional efficacy instruments included a Global Assessment Question (GAQ). RESULTS Compared with placebo, tadalafil gave significantly better outcomes. Patients receiving either dose of tadalafil had a significant mean improvement of 6.5 and 8.6, respectively, in the IIEF erectile function domain score from baseline (P < 0.001 vs placebo). At both doses the mean success rate for intercourse attempts (SEP‐Q3) was 58% and 68%, respectively, compared with 31% in the placebo group (P < 0.001), and 71% and 84% reported improved erections at the endpoint (GAQ), vs 33% on placebo (P < 0.001). Tadalafil was effective up to 36 h after dosing and was effective regardless of disease severity and causes, and in patients of all ages. The most frequent adverse events were headache, dyspepsia, back pain and myalgia. CONCLUSION Tadalafil was an effective and well‐tolerated treatment for ED.

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