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

Full Abstract

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.

Learn Faster Today Improve your study skills

Author information

Author/s: Kriston, L (L); Harms, A (A); Berner, M M (MM);

Affiliation: Department of Psychiatry and Psychotherapy, Freiburg University Medical Center, Freiburg, Germany.

Journal and publication information

Publication Type: Journal Article; Meta-Analysis

Journal: International journal of impotence research (Int J Impot Res), published in England. (Language: eng)

Reference: -2006 Nov-Dec; vol 18 (issue 6) : pp 559-65

Dates: Created 2006/10/31; Completed 2007/01/04; Revised 2007/11/15;

PMID: 16688210, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article (including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Male
Phosphodiesterase Inhibitors - administration & dosage; therapeutic use
Piperazines - administration & dosage; therapeutic use
Purines
Regression Analysis
Sulfones

Associated Chemicals: Phosphodiesterase Inhibitors (0) ; Piperazines (0) ; Purines (0) ; Sulfones (0) ; sildenafil (139755-83-2)

These are the highest related articles currently in the database:

See 100+ related articles.