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  • Title: Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: results of integrated analyses.
    Author: Rubio-Aurioles E, Casabé A, Torres LO, Quinzaños L, Glina S, Filimon I, Kopernicky V, Leñero E.
    Journal: J Sex Med; 2008 Aug; 5(8):1965-76. PubMed ID: 18466266.
    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 < 0.001, respectively, vs. placebo). At both doses, the mean success rate for penetration was 75 and 86%, respectively, compared with 56% on placebo (P < or = 0.001), the mean success rate for intercourse was 55% and 78%, compared with 36% on placebo (P < 0.001 vs. placebo), and 62% and 91% of patients, respectively, reported improved erections at the end point, vs. 43% on placebo (P = 0.160 and P < 0.001, respectively, vs. placebo). The most frequent AEs were headache, dyspepsia, and back pain. CONCLUSIONS: 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.
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