Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports

Markou, S.; Perimenis, Petros; Gyftopoulos, Kostis; Athanasopoulos, Anastasios; Barbalias, George A.

doi:10.1038/sj.ijir.3901258

Cited by 45 publications

(24 citation statements)

References 28 publications

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“…Although some of the primary studies analyze efficacy in patient subgroups, the study reports go rarely beyond simple description, and statistical testing of confounding effects is not even performed in meta-analyses. [10][11][12] The objective of the present meta-analytic regression analysis was to investigate various possible treatment effect modifiers in trials with oral sildenafil for ED. We considered (1) core parameters that can function as mediators or moderators of the treatment effect (such as trial and patient characteristics) and (2) distorting issues that can bias study findings and their dissemination (such as bias relating to methodological quality and publication).…”

Section: Introductionmentioning

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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Section: Introductionmentioning

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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“…Animal models and plaques derived from men with PD have increased TGF-β expression in the tunica albuginea [14,16]. The focal areas of fibrous tissue are laid down in this subtunical layer, which is eventually completely replaced by fibrous tissue.…”

Section: Discussionmentioning

confidence: 99%

A Preliminary Study on Possible Effects of Mitomycin-C on the Collagen Content of Penis in Rat

Hosseini¹,

Mohseni²,

Alizadeh³

2016

UNOAJ

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“…This hampered our investigation of the relationship between study Bias in systematic reviews GE Bekkering et al 267 (25,50, 100) refers to a four armed trial, one group had placebo, a second received 25 mg, a third 50 mg and the last group 100 mg. Our extensive search resulted in the inclusion of 22 additional studies compared to previously performed meta-analyses. [1][2][3]5,10 There are indications that more trials have been performed as some reviews included several unpublished trials that could not be obtained by us. It is not clear whether results of those studies are published or not.…”

Section: Discussionmentioning

confidence: 99%

“…Finally, reference lists of all included studies and of recent systematic reviews were screened for missed references. [1][2][3]5,10 There was no language restriction and published as well as unpublished studies and abstracts were included.…”

Section: Searchingmentioning

confidence: 99%

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The application of quantitative methods for identifying and exploring the presence of bias in systematic reviews: PDE-5 inhibitors for erectile dysfunction

Bekkering

Abou‐Setta²,

Kleijnen

2007

Int J Impot Res

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A systematic review of PDE-5 inhibitors for erectile dysfunction was performed to evaluate the utility of quantitative methods for identifying and exploring the influence of bias and study quality on pooled outcomes from meta-analyses. We included 123 randomized controlled trials (RCTs). Methodological quality was poorly reported. All three drugs appeared highly effective. Indirect adjusted analyses showed no differences between the three drugs. Funnel plots and statistical tests showed no evidence of small-study effects for sildenafil whereas there was evidence of such bias for tadalafil and vardenafil. Adjustment for missing studies using trim and fill techniques did not alter the pooled estimates substantially. The exclusion of previous sildenafil nonresponders was associated with larger treatment effects for tadalafil. This investigation was hampered by poor reporting of methodological quality, a low number of studies, heterogeneity and large effect sizes. Despite such limitations, a comprehensive assessment of biases should be a routine in systematic reviews.

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Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports

Cited by 45 publications

References 28 publications

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

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

A Preliminary Study on Possible Effects of Mitomycin-C on the Collagen Content of Penis in Rat

The application of quantitative methods for identifying and exploring the presence of bias in systematic reviews: PDE-5 inhibitors for erectile dysfunction

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