Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: results of integrated analyses.

Autor: Rubio-Aurioles E; Asociación Mexicana para Salud Sexual A.C., Mexico city, Mexico. eusebio@amssac.org, Casabé A, Torres LO, Quinzaños L, Glina S, Filimon I, Kopernicky V, Leñero E
Jazyk: angličtina
Zdroj: The journal of sexual medicine [J Sex Med] 2008 Aug; Vol. 5 (8), pp. 1965-76. Date of Electronic Publication: 2008 May 05.
DOI: 10.1111/j.1743-6109.2008.00860.x
Abstrakt: 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.
Databáze: MEDLINE
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