Evidence Hub

A comparative evaluation of phosphodiesterase-5 inhibitors in erectile dysfunction treatment: a systematic review and network meta-analysis of double-blinded, placebo-controlled, randomized trials

A. Salonia, C. W, E. Jannini

Journal of Sexual Medicine, 2025

Abstract

Abstract Objectives Erectile dysfunction (ED) is a multifaceted condition with underlying psychogenic, neurogenic, vascular, and hormonal factors, affecting 10–48% of global male population. The European Medicine Agency (EMA) has approved four phosphodiesterase-5 inhibitors (PDE5is), primarily sildenafil, tadalafil, vardenafil, and avanafil in different dosage forms, as the treatment for men with ED. This study aimed to establish a comparative efficacy and safety profile of the four PDE5is for treating men with ED. Methods A comprehensive search was performed in PubMed-Medline, EMBASE, Scopus, Cochrane CENTRAL, and other databases to identify randomized, double-blinded, placebo-controlled trials on the management of ED with PDE5is. Studies reporting changes from baseline using International Index of Erectile Function (IIEF) domains, Global Assessment Question (GAQ)/Global Efficacy Questions (GEQ), and Sexual Encounter Profile (SEP) questionnaires were prioritized. Only on-demand dosages were selected for network meta-analysis (NMA), and the primary outcomes considered were 1) the proportion of participants achieving satisfactory erectile function (EF), defined as an IIEF–EF domain score > 26 and 2) the proportion of participants achieving no ED status, based on either the IIEF–EF domain or relevant questions from the GAQ, GEQ, or SEP 2 and 3.The risk of bias of the included studies was performed using the Cochrane Risk of Bias tool. Results The NMA included 83…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

Read the paper

Related studies

Go deeper in Evidence Hub

Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.

Open this study Sign up free