A baseline-controlled, open-label, flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra®) in patients with erectile dysfunction

Benchekroun, A; Faïk, M; Benjelloun, S; Bennani, S; Mrini, M. El; Smires, A.

doi:10.1038/sj.ijir.3900969

Cited by 17 publications

(9 citation statements)

References 28 publications

(34 reference statements)

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“…Effectiveness of the agents is also confirmed in open-label naturalistic studies. [35][36][37] After establishing evidence for efficacy and pointing out towards possible efficacy differences, further information is needed in questions that mainly affect patient's compliance and preferences. This might include the effects on quality of life (e.g.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations

2005

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This meta-analytic study aims to estimate the likely improvements of erectile dysfunction (ED) measured by the International Index of Erectile Function (IIEF) at the highest fixed dosages of the three available PDE-5-inhibitors: sildenafil, tadalafil, and vardenafil. MEDLINE and the Cochrane Library were searched electronically for efficacy trials of PDE-5-inhibitors for treating ED. In addition drug manufacturers were contacted to provide unpublished or unrecorded congress proceedings. Randomized, double-blind, placebo-controlled, parallel-group, maximum fixed-dose, broad-spectrum efficacy trials using IIEF were included in the analysis. Data were independently extracted by two reviewers. The results were pooled using weighted mean differences. A formal indirect comparison (including Bonferroni-correction) was conducted to estimate the differences between agents. A total of 14 trials were included in the meta-analysis (three with 100 mg sildenafil, eight with 20-25 mg tadalafil, and three with 20 mg vardenafil). All trials were of good methodological quality. Overall heterogeneity was moderate: I 2 ¼ 33.2%, v 2 ¼ 19.47, P ¼ 0.11. The funnel plot suggested moderate likelihood of publication bias. Pooled results of IIEF-improvement were for sildenafil 9.65 (95% CI: 8.50, 10.79) points, tadalafil 8.52 (7.61, 9.42) points, and vardenafil 7.50 (6.50, 8.50) points, respectively. Sildenafil proved to be significantly more effective than vardenafil (d ¼ 2.15, P ¼ 0.006), other pairwise comparisons showed no difference in efficacy. All PDE-5-inhibitors are highly effective in the treatment of ED. At maximum dosage they improve erectile function 7-10 points on the IIEF compared to placebo-treatment. There is evidence that sildenafil might be more efficacious than vardenafil, although this is to be interpreted with caution. To prove higher efficacy truly independent comparative trials are needed.

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Section: Discussionmentioning

confidence: 99%

Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations

2005

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“…The efficacy, safety, minimal invasiveness, and nonspecificity of sildenafil have been reported in the therapeutic management of ED. 1 These results have raised the hypothesis that sildenafil can be placed as the first-step therapeutic tool for Japanese males with ED. The aim of this study was to examine this hypothesis.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of sildenafil as the first-step therapeutic tool for Japanese patients with erectile dysfunction

et al. 2005

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patients were prescribed five tablets of sildenafil (50 mg) as the first step in the therapeutic management of ED. Of the 281 patients, 206 were evaluable patients. The overall success rate in achieving sexual intercourse in subjects after taking sildenafil was 77.2% (159/206), while 22.8% (47/206) were unsuccessful. The success rates in men with functional ED and organic ED were 91.4% (85/93) and 65.5% (74/113), respectively (Po0.0001). Overall, transient adverse effects of sildenafil occurred in 16 (8%) males. Intolerable adverse effects (edema and dizziness) occurred in only 1% of patients (2/206). Sildenafil citrate may be recommended as the first choice drug for ED because of its high success rate and low invasiveness.

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“…Sildenafil citrate is widely used as an effective and safe oral treatment for erectile dysfunction of various etiologies (Goldstein et al, 1998;Cheitlin et al, 1999;Benchekroun et al, 2003). It is a potent and selective inhibitor of phosphodiesterase type 5 enzymes that acts to break down cyclic guanosine monophosphate (cGMP) (Boolell et al, 1996).…”

Section: Introductionmentioning

confidence: 99%

The Effects of Sildenafil Citrate on the Liver and Kidneys of Adult Wistar Rats (Rattus norvegicus) – A Histological Study

Eweka¹

2011

Sexual Dysfunctions - Special Issues

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A baseline-controlled, open-label, flexible dose-escalation study to assess the safety and efficacy of sildenafil citrate (Viagra®) in patients with erectile dysfunction

Cited by 17 publications

References 28 publications

Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations

Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations

Efficacy of sildenafil as the first-step therapeutic tool for Japanese patients with erectile dysfunction

The Effects of Sildenafil Citrate on the Liver and Kidneys of Adult Wistar Rats (Rattus norvegicus) – A Histological Study

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