Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers
ABSTRACT To determine the efficacy, safety, and treatment satisfaction of tadalafil 20 mg for erectile dysfunction (ED) in patients evaluated at tertiary-care academic centers.
In this randomized, double-blind, placebo-controlled trial, patients were randomly allocated to receive fixed-dose tadalafil 20 mg (n = 146) or placebo (n = 49) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ); patient and partner treatment satisfaction by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and SEP; and safety by adverse events, laboratory values, and vital signs.
Mean baseline IIEF erectile function (EF) domain was 12.98. Fifty-one percent of enrolled patients had severe baseline ED, and 82% had organic ED. Pre-existing, ED-associated comorbid conditions were common. When compared with patients treated with placebo, those receiving tadalafil reported significant improvement from baseline in the IIEF EF domain (P <0.001), successful penetration attempts (SEP question 2; P <0.001), successful intercourse (SEP question 3; P <0.001), and all secondary efficacy outcomes (P <0.001). Patients and their sexual partners were also significantly more satisfied with tadalafil treatment (P <0.001), including overall satisfaction (P <0.001) and length of time the treatment worked (P <0.001). Mild or moderate headache, dyspepsia, and myalgia were the most frequent treatment-emergent adverse events reported.
Tadalafil significantly improved erectile function and patient and partner satisfaction and was well tolerated. These results were observed in a tertiary-care, academic center population with a high incidence of severe, organic ED, and comorbid medical conditions, factors known to compromise erectile function and treatment outcome.
- SourceAvailable from: Antonio Aversa[Show abstract] [Hide abstract]
ABSTRACT: Previous studies established the efficacy of once-daily tadalafil for men with erectile dysfunction. However, no trial has focused on the effects of such treatment on men without previous experience using oral phosphodiesterase type 5 (PDE5) inhibitors. Subjects were randomized (2:1) to once-daily tadalafil 5 mg (with possible down-titration to 2.5 mg; n = 146) or placebo (n = 69) for 12 weeks. Among 215 subjects (mean age = 52 years), once-daily tadalafil treatment resulted in 61.7% of study participants reporting their ability to achieve and maintain erections being much better or very much better (vs. 21.7% on placebo; P < .001). Tadalafil significantly improved treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS; P < .001 vs. placebo at endpoint) and psychosocial outcomes on the Self-Esteem and Relationship (SEAR) questionnaire (least-squares mean difference in SEAR total score change from baseline = 11.8 [95% CI = 5.4-18.2; P < .001 vs. placebo]). Subjects receiving once-daily tadalafil also experienced a higher proportion of daily self-reported spontaneous morning erections at endpoint (58.7%) compared to placebo (42.2%; P < .001 for the between-treatment difference in changes from baseline). However, no significant differences in parameters of endothelial dysfunction (including biomarkers and peripheral arterial tonometric measures) or nocturnal erections as recorded by the nocturnal electrobioimpedance volumetric assessment were observed between treatment groups. Tadalafil was well tolerated; adverse events included back pain, headache, and dyspepsia. These findings may contribute to a more comprehensive understanding of once-daily tadalafil's effects on PDE5-inhibitor-naive men.Journal of Andrology 07/2012; 33(6). DOI:10.2164/jandrol.111.015289 · 1.69 Impact Factor
- Value in Health 11/2002; 5(6):560-560. DOI:10.1016/S1098-3015(10)61477-5 · 2.89 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: There are no randomised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting. Valid indirect comparisons with a common comparator must examine equivalent doses, similar duration, similar populations, with the same outcomes reported in the same way. Published randomised, double-blind trials of oral PDE-5 inhibitors for erectile dysfunction were sought from reference lists in previous reviews and electronic searching. Analyses of efficacy and harm were carried out for each treatment, and results compared where there was a common comparator and consistency of outcome reporting, using equivalent doses. Analysis was limited by differential reporting of outcomes. Sildenafil trials were clinically and geographically more diverse. Tadalafil and vardenafil trials tended to use enriched enrollment. Using all trials, the three interventions were similar for consistently reported efficacy outcomes. Rates of successful intercourse for sildenafil, tadalafil and vardenafil were 65%, 62%, and 59%, with placebo rates of 23-28%. The rates of improved erections were 76%, 75% and 71%, respectively, with placebo rates of 22-24%, and NNTs of 1.9 or 2.0. Reporting of withdrawals was less consistent, but all-cause withdrawals for sildenafil, tadalafil and vardenafil were 8% 13% and 20%. All three drugs were well tolerated, with headache being the most commonly reported event at 13-17%. There were few serious adverse events. There were differences between trials in outcomes reported, limiting comparisons, and the most useful outcomes were not reported. For common outcomes there was similar efficacy between PDE-5 inhibitors.BMC Urology 02/2005; 5:18. DOI:10.1186/1471-2490-5-18 · 1.94 Impact Factor