title: Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: results of integrated analyses.
abstract: 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.
authors.affiliation: Asociación Mexicana para Salud Sexual A.C., Mexico city, Mexico. eusebio@amssac.org
authors.forename: Eusebio
authors.initials: E
authors.lastname: Rubio-Aurioles
authors.forename: Adolfo
authors.initials: A
authors.lastname: Casabé
authors.forename: Luiz O
authors.initials: LO
authors.lastname: Torres
authors.forename: Luis
authors.initials: L
authors.lastname: Quinzaños
authors.forename: Sidney
authors.initials: S
authors.lastname: Glina
authors.forename: Ioana
authors.initials: I
authors.lastname: Filimon
authors.forename: Vladimir
authors.initials: V
authors.lastname: Kopernicky
authors.forename: Enrique
authors.initials: E
authors.lastname: Leñero
mesh_terms: 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
chemical_list: D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil