Tadalafil Once Daily in Men with Erectile Dysfunction: An Integrated Analysis of Data Obtained from 1913 Patients from Six Randomized, Double-blind, Placebo-controlled, Clinical Studies

Abstract

BackgroundThis analysis explores tadalafil once-daily treatment for 12 wk in clinical subpopulations of men with erectile dysfunction (ED). ObjectiveAssess the efficacy and safety of once-daily tadalafil 2.5mg and 5mg in patients with different ED characteristics and comorbidities. Design, setting, and participantsThis analysis integrated data from six randomized, double-blind, placebo-controlled studies that assigned 1913 men with ≥3-mo history of ED either to once-daily placebo (n=596), tadalafil 2.5mg (n=394), or tadalafil 5mg (n=923). Clinical factors examined included: ethnicity, age, obesity, alcohol consumption, smoking, comorbidities, concomitant medication, and ED characteristics (etiology, duration, severity). Outcome measurements and statistical analysisDescriptive statistics were reported for efficacy and safety, including International Index of Erectile Function Erectile Function Domain (IIEF-EF) scores and Sexual Encounter Profile question 3 (SEP3) responses. Clinical factors were included in analysis of covariance models using last observation carried forward for SEP3 and IIEF-EF scores. Results and limitationsBoth tadalafil doses significantly improved SEP3 responses (least-squares [LS] mean change: 17.8% and 23.6%, respectively) and IIEF-EF scores (LS mean change: 4.2; 5.4) compared with placebo (p<0.01). Treatment with 2.5mg and 5mg tadalafil resulted in IIEF-EF LS mean improvements ≥4 (minimal clinically important difference [MCID]) in patients with hypertension (4.3 [95% confidence interval (CI), 2.9–5.7]; 4.7 [95% CI, 3.5–5.8]), cardiac disorder (7.0 [95% CI, 4.7–9.3]; 6.3 [95% CI, 4.4–8.2]), or hyperlipidemia (5.3 [95% CI, 3.4–7.1]; 5.8 [95% CI, 4.3–7.4]). Obese patients (4.7 [95% CI, 3.4–6.0]), smokers (4.8 [95% CI, 3.0–6.7]), and psychogenic ED (7.3 [95% CI, 5.0–9.6]) reached MCID only after treatment with 5mg tadalafil. Severity-specific MCID (IIEF-EF change ≥7) was achieved by 44.5% of patients with severe baseline ED treated with tadalafil 5mg, compared with 11.6% of placebo-treated patients. No unexpected safety findings were observed. These analyses were performed on integrated data and can only provide descriptive results to guide further investigations. ConclusionsTreatment with tadalafil 2.5mg or 5mg once daily was well tolerated and resulted in clinically important improvements in patients with mild (54.3% and 74.8%, respectively), moderate (51.3% and 63.1%, respectively), or severe (33.7% and 44.5%, respectively) ED.