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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.

SUBMITTER: Guo YL

PROVIDER: S-EPMC3735316 | biostudies-other | 2009 Jul

REPOSITORIES: biostudies-other

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Project description:BACKGROUND:Clinical study and practice data have shown sildenafil improves sexual function in men with erectile dysfunction (ED). However, some men treated with placebo in double-blind, placebo-controlled sildenafil studies also report improved erectile function as measured by International Index of Erectile Function (IIEF)-Erectile Function Domain (EFD) scores. AIM:This analysis estimated the relationship between post-baseline IIEF-EFD scores and demographic variables, including co-morbidities, in men with ED receiving placebo in flexible-dose sildenafil studies. METHODS:Placebo-treated participants in the intent-to-treat population of 42 double-blind, placebo-controlled, flexible-dose, sildenafil studies were included. A participant was classified as a placebo responder if the IIEF-EFD score was ≥26 at the last visit. OUTCOMES:Variables assessed were age (<45, 45-64, ≥65 years), race, body mass index, co-morbidities (cardiovascular disease/hypertension, diabetes mellitus, depression), date the last study dose was taken, study completion date, ED etiology (psychogenic, organic, mixed), history of cigarette smoking, ED duration, baseline IIEF-EFD score (≤10, 11-16, ≥17), and treatment duration. Stepwise multivariate logistic regression models assessed the odds of being a responder vs a non-responder for each variable. RESULTS:A total of 4,360 men were included; 13.5% were responders. Odds estimates indicated the largest likelihood of placebo response occurred in men who were black (odds = 20.2, P < .0001), were younger than 45 years (odds = 7.3, P < .0001), had mild ED (baseline IIEF-EFD ≥17; odds >100, P < .0001), and did not have diabetes (odds = 4.5, P < .0001). The likelihood of a placebo response decreased as ED duration increased (odds = 0.74, P < .0001). The frequency of common adverse events was similar between placebo responders and non-responders. CLINICAL TRANSLATION:These findings contribute to the improved understanding of predictors of placebo response in sildenafil clinical studies. Elucidation of these factors may contribute to the development of further interventions and treatment strategies and best practices for clinical trials. STRENGTHS AND CONCLUSIONS:Strengths of this analysis include the large and diverse population and the duration of follow-up. Limitations include those associated with retrospective analyses and the inability to ascertain to what extent other demographic factors might have contributed to the placebo responses or how these placebo responses might be related to the natural course of ED. CONCLUSIONS:Certain demographics, co-morbidities, and condition characteristics predicted the odds of a placebo response in sildenafil clinical studies of ED. Underlying reasons behind a placebo response warrant further evaluation. Mulhall JP, Carlsson M, Stecher V, et al. Predictors of Erectile Function Normalization in Men With Erectile Dysfunction Treated With Placebo. J Sex Med 2018;15:866-872.

Project description:IntroductionSeveral studies have investigated the association between erectile dysfunction (ED), its treatment, and female sexual dysfunction, but the impact of males blaming their female partners for their ED remains unknown.AimsTo investigate whether women who are blamed by their male partners for their ED experience worse overall sexual function and satisfaction.MethodsWe performed a global, cross-sectional web-based survey to investigate female perceptions of ED. We distributed the 30-item survey via email, Reddit, Amazon Mechanical Turk, and Facebook. Women 18 years of age or older were eligible to participate and answered questions based on a 5-point Likert scale. Women were grouped by ages 18-29, 30-39, and 40 and older.Main outcome measuresThe survey collected data that included general demographics and questions regarding experiencing male blame for ED and its relationship with each subject's sexual health and wellness.ResultsA total of 13,617 females participated in the survey. Of the women surveyed, 79% have experienced their partner losing their erection during sexual activity and approximately 1 out of 7 women (14.7%) had experienced being blamed by their partner for loss of their erection. Women who were blamed for their partner's ED were more likely to end the sexual encounter, were less sexually satisfied, and were more likely to end relationships due to their partner's ED.ConclusionApproximately 1 out of 7 women have experienced male blame for their partner's ED which is associated with negative impacts on female mental health, sexual satisfaction and the success of the overall partnership. Because of its widespread impact on female wellness, male blame should be considered during evaluation of female sexual history and men must be educated on the significant impact their reactions during intimacy have on their female partners and their relationships as a whole. Dubin JM, Wyant WA, Balaji NC, et al. Is Female Wellness Affected When Men Blame Them for Erectile Dysfunction?. Sex Med 2021;9:100352.

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

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