Efficacy and safety of sildenafil citrate (Viagra®) in black and Hispanic American men

Young, Jay M.; Bennett, Carol J.; Gilhooly, Patricia; Wessells, Hunter; Ramos, Diana

doi:10.1016/s0090-4295(02)01689-8

Cited by 37 publications

(27 citation statements)

References 17 publications

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“…Traditional noninferiority trials can be used to demonstrate comparable efficacy between active In contrast to another study of ethnic populations with sildenafil, 21 the Hispanic population in MO-MENTUS had a higher percentage of patients with mixed ED etiology than the other ethnic groups, and was younger with less severe ED, suggesting a desire to seek early treatment. A higher percentage of Black American patients in MOMENTUS had body mass index X30 kg/m 2 , were more likely to smoke, and, similar to the study with sildenafil and another study with vardenafil, had a higher occurrence of cardiovascular disease (including hypertension).…”

Section: Discussionmentioning

confidence: 99%

“…A higher percentage of Black American patients in MOMENTUS had body mass index X30 kg/m 2 , were more likely to smoke, and, similar to the study with sildenafil and another study with vardenafil, had a higher occurrence of cardiovascular disease (including hypertension). 21,22 Despite the differences in baseline characteristics, tadalafil 20 mg improved the EF of patients who were Caucasian, Black American, or Hispanic. Across all three groups, the mean change in the IIEF EF domain was statistically significant and clinically relevant.…”

Section: Discussionmentioning

confidence: 99%

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Tadalafil is efficacious in Black American and Hispanic men with erectile dysfunction: results from multiple observations in men with erectile dysfunction in national tadalafil study in the US (MOMENTUS)

et al. 2006

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To show that tadalafil is efficacious in Black American and Hispanic men with erectile dysfunction (ED) and efficacy is noninferior to that in Caucasian men. Multiple observations in men with ED in national tadalafil study in the US, a multicenter, open-label study, assessed the efficacy of tadalafil 20 mg taken as needed (maximum one dose/day before sexual activity) for 12 weeks by patients with ED in various populations. This analysis focuses on three groups: Caucasian (Reference group), Black American, and Hispanic men. Primary measurement of efficacy was change from baseline in erectile function (EF) domain of the International Index of Erectile Function (IIEF) and the primary analysis was whether efficacy in Black American and Hispanic groups was noninferior to efficacy in the Caucasian group. Secondary efficacy measures included sexual encounter profile (SEP), IIEF intercourse satisfaction (IS) and overall satisfaction (OS) domains, Global Assessment Question (GAQ), and Psychological and Interpersonal Relationship Scale (PAIRS). Safety was assessed from adverse events (AEs) reported by all enrolled patients. The increase in IIEF EF domain score (>or=9.5) from baseline for each group was statistically significant (P<0.001) and clinically relevant. Efficacy of tadalafil in Black American and Hispanic patients was noninferior to the Caucasian group. IS and OS domains of IIEF had a statistically significant increase from baseline (P<0.001). Change from baseline in positive responses to SEP questions for each group was significant (P<0.001). At least 77% of intercourse attempts were successful over various time intervals up to 36 h postdose. At least 88% of patients in the various groups had a positive response to GAQ1. Improvement from baseline in Sexual Self-Confidence and Spontaneity domains of PAIRS was statistically significant (P<0.001). A low number of AEs and a low AE-related discontinuation rate (2.3%) were reported in all groups. Tadalafil 20 mg was as efficacious in Black American and Hispanic men with ED as in Caucasian patients and was well tolerated.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Tadalafil is efficacious in Black American and Hispanic men with erectile dysfunction: results from multiple observations in men with erectile dysfunction in national tadalafil study in the US (MOMENTUS)

et al. 2006

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“…Of them, a total of 13 trials fulfilled all inclusion criteria and were included in the meta-regression analysis. [23][24][25][26][27][28][29][30][31][32][33][34][35] Characteristics of the included trials are presented in Table 1.…”

Section: Included Trialsmentioning

confidence: 99%

A meta-regression analysis of treatment effect modifiers in trials with flexible-dose oral sildenafil for erectile dysfunction in broad-spectrum populations

2006

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Several trials and reviews provide evidence for the efficacy of phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction (ED). However, little is known about the impact of treatment effect modifiers other than concomitant diseases. Our objective was to identify patient and trial characteristics as well as methodological and publication-related issues that are associated with the treatment effect measured in flexible-dose randomized controlled trials of oral sildenafil for ED. The MEDLINE and the Cochrane Central databases were searched for efficacy trials of sildenafil. Thirteen trials fulfilled all inclusion criteria. A series of meta-regression and graphical analyses were performed to test the impact of possible effect modifiers. Treatment effect was influenced by mean baseline disease severity and mean duration of the disease. These associations were at least partly mediated by placebo response. Trial duration, age of patients and etiology of ED in patients did not have any significant influence on the treatment effect. The year of publication of primary trials was also related to trial findings. Our analysis adds important data to enable the control of confounding variables in future trials and meta-analyses. It might also help the individual to assess the unbiased efficacy and true innovative potential of available and forthcoming pharmacological agents.

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“…In addition to introducing cardiovascular [2] and respiratory diseases [3], as well as many types of cancer [4], smoking has been associated with elevated rates of erectile dysfunction (ED). ED is considered a significant public health problem and is estimated to affect 34 million men in the USA and > 150 million men worldwide [5, 6]. Large cross-sectional [7–11] and longitudinal [12] epidemiological studies indicate that chronic smokers are about 1.5 to 2-times as likely as nonsmokers to report ED, even after controlling for age and confounding cardiovascular risk factors.…”

Section: Introductionmentioning

confidence: 99%

Association between smoking cessation and sexual health in men

Harte

Meston

2011

BJU International

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Objective To provide the first empirical investigation of the association between smoking cessation and indices of physiological and subjective sexual health in men. Subjects and methods Male smokers, irrespective of erectile dysfunction status, who were motivated to stop smoking (‘quitters’), were enrolled in an 8-week smoking cessation programme involving a nicotine transdermal patch treatment and adjunctive counselling. Participants were assessed at baseline (while smoking regularly), at mid-treatment (while using a high-dose nicotine transdermal patch), and at a 4-week post-cessation follow-up. Physiological (circumferential change via penile plethysmography) and subjective sexual arousal indices (continuous self-report), as well as self-reported sexual functioning were assessed at each visit. Results Intent-to-treat analyses indicated that, at follow-up, successful quitters (n = 20), compared with those who relapsed (n = 45), showed enhanced erectile tumescence responses, and faster onset to reach maximum subjective sexual arousal. Although successful quitters displayed across-session enhancements in sexual function, they did not show a differential improvement compared with unsuccessful quitters. Conclusion Smoking cessation significantly enhances both physiological and self-reported indices of sexual health in long-term male smokers, irrespective of baseline erectile impairment. It is hoped that these results may serve as a novel means to motivate men to stop smoking.

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Efficacy and safety of sildenafil citrate (Viagra®) in black and Hispanic American men

Cited by 37 publications

References 17 publications

Tadalafil is efficacious in Black American and Hispanic men with erectile dysfunction: results from multiple observations in men with erectile dysfunction in national tadalafil study in the US (MOMENTUS)

Tadalafil is efficacious in Black American and Hispanic men with erectile dysfunction: results from multiple observations in men with erectile dysfunction in national tadalafil study in the US (MOMENTUS)

A meta-regression analysis of treatment effect modifiers in trials with flexible-dose oral sildenafil for erectile dysfunction in broad-spectrum populations

Association between smoking cessation and sexual health in men

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