Efficacy and Safety of Tadalafil in the Treatment of Latin American Men with Erectile Dysfunction: Results of Integrated Analyses

ABSTRACT Introduction Available information on the efficacy and safety of tadalafil on Latin American men comes from reports where data is mixed with other populations. Aim To assess the efficacy and safety of tadalafil in Latin American men with erectile dysfunction (ED). Methods Integrated analyses of data from four 12‐week, randomized, double‐blind, parallel, placebo‐controlled trials conducted in Latin America that assessed the efficacy and safety of tadalafil in 406 Latin American men with ED of diverse etiology and severity assigned to placebo (N = 113), 10‐mg tadalafil (N = 39), or 20‐mg tadalafil (N = 254). Main Outcome Measures Efficacy was assessed by International Index of Erectile Function Erectile Function (IIEF‐EF) domain, questions 2 to 5 of the Sexual Encounter Profile and the first Global Assessment Question. Adverse events (AEs) reported by all enrolled patients were collected. Results Latin American patients treated with 10 or 20 mg of tadalafil had a significant mean improvement of 4.92 and 9.78, respectively, in the IIEF‐EF domain score from baseline compared with 2.24 on placebo ( P  = 0.003 and P P  ≤ 0.001), the mean success rate for intercourse was 55% and 78%, compared with 36% on placebo ( P P  = 0.160 and P Conclusion 10 or 20 mg tadalafil was an effective, safe, and well‐tolerated therapy for Latin American men with ED of diverse etiology despite of ED severity. Rubio‐Aurioles E, Casabe A, Torres LO, Quinzanos L, Glina S, Filimon I, Kopernicky V, and Lenero E. Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: Results of integrated analyses. J Sex Med 2008;5:1965–1976.