Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

Abstract

We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population (with varying patient demographics, disease severity, and comorbid medical conditions) of Asian men with erectile dysfunction (ED). An integrated analysis of five double-blind, placebo-controlled trials (N = 1 046) was performed. Patients were randomly assigned to receive 10 mg tadalafil (N = 185), 20 mg tadalafil (N = 510), or placebo (N = 351). Efficacy assessments included the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary and Global Assessment Question (GAQ). Patients receiving 10 mg or 20 mg tadalafil showed significant improvement from baseline-to-end point on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) domain score in all clinical sub-populations analyzed, compared with patients receiving placebo (P < 0.001). The 10-mg and 20-mg tadalafil groups showed a mean success rate of 64.1% and 70.5% for sexual intercourse attempts (SEP3, successful intercourse), respectively, compared with 33.4% in the placebo group (P < 0.001), and 85.5% and 85.4% reported improved erections at end point GAQ, respectively, versus 43.5% in the placebo group (P < 0.001). Tadalafil was well tolerated across all groups studied. Headache and back pain were the most frequently reported adverse events. Overall, tadalafil was effective and well tolerated across a diverse clinical spectrum of Asian men with ED.

Figure 1

Patient disposition.

Figure 2

Baseline mean International Index of Erectile Function (IIEF) EF domain scores and least squares mean scores at the end point for placebo, 10-mg tadalafil, and 20-mg tadalafil groups. (A): Scores for clinical sub-populations based on patient demographics, (B): scores for clinical sub-populations based on ED severity and comorbid medical conditions. ED severity categories were determined based on a modified version of the definition described by Cappelleri et al. . ^***: IIEF-EF domain score < 11, severe; 11–16, moderate; 17–30, mild. DM, diabetes mellitus; HTN, hypertension; CVD, cardiovascular disease. ^*P < 0.001, least squares mean improvement vs. placebo. ^†P < 0.05, least squares mean improvement of 20 mg vs. 10 mg tadalafil.

Figure 3

Baseline mean per-patient percentage of successful intercourse (Sexual Encounter Profile question 3 [SEP3]) and least squares mean percentage at the end point for the placebo, 10-mg tadalafil, and 20-mg tadalafil groups. (A): Scores for clinical sub-populations based on patient demographics, (B): scores for clinical sub-populations based on ED severity and comorbid medical conditions. ED severity categories were based on a modified version of the definition described by Cappelleri et al. : IIEF-EF domain score < 11, severe; 11–16, moderate; 17–30, mild. DM, diabetes mellitus; HTN, hypertension; CVD, cardiovascular disease. ^*P < 0.001, least squares mean improvement vs. placebo. ^†P < 0.05, least squares mean improvement of 20 mg vs. 10 mg tadalafil.

Figure 4

Efficacy analyses by geographic region. (A): Baseline mean International Index of Erectile Function (IIEF) EF domain scores and least squares mean scores at end point for placebo, 10-mg tadalafil, and 20-mg tadalafil groups. (B): Baseline mean per-patient percentage of successful intercourse (Sexual Encounter Profile question 3 [SEP3]) and least squares mean percentage at end point for placebo, 10-mg tadalafil, and 20-mg tadalafil groups. ^†Others = Hong Kong (China), Indonesia, Malaysia. ^*P < 0.001, ^**P < 0.05, least squares mean improvement vs. placebo.