Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: results of integrated analyses.
BACKGROUND
Available information on the efficacy and safety of tadalafil on Latin American men comes from reports where data is mixed with other populations.


OBJECTIVE
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).


METHODS
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.
Rubio-Aurioles
Eusebio
E
Asociación Mexicana para Salud Sexual A.C., Mexico city, Mexico. eusebio@amssac.org
Casabé
Adolfo
A
Torres
Luiz O
LO
Quinzaños
Luis
L
Glina
Sidney
S
Filimon
Ioana
I
Kopernicky
Vladimir
V
Leñero
Enrique
E
D000328:Adult; D000368:Aged; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D007843:Latin America; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D016896:Treatment Outcome
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil