Phosphodiesterase-5 inhibitors for erectile dysfunction in patients with diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials

BACKGROUND AND AIMS: Patients with diabetes mellitus frequently experience erectile dysfunction. This systematic review and meta-analysis were conducted to find efficacy and tolerability of phosphodiesterase 5 (PDE5) inhibitors in patients with diabetes mellitus experiencing erectile dysfunction. METHODOLOGY: Electronic searches were carried out to identify English language peer-reviewed randomized controlled trials (RCTs), which reported clinical efficacy of any PDE5 inhibitor in patients with diabetes mellitus having erectile dysfunction. Effect sizes were computed using Cohen's d, and I(2)-test was used to assess heterogeneity. Pooled mean effect sizes were computed using random-effects model. Number needed to treat (NNT), and the adverse event rates were computed. RESULTS: The systematic review included a total of 17 studies yielding 25 comparisons. Three studies were open RCTs while others were double-blind RCTs. The pooled mean effect size of any PDE5 inhibitor over placebo was 0.926 (95% confidence intervals [CI]: 0.864-0.987; I(2) =26.3). The pooled mean effect size for sildenafil was 1.198 (CI: 1.039-1.357; I(2) =0), for tadalafil was 0.910 (CI: 0.838-0.981; I(2) =33.6), and for vardenafil was 0.678 (CI: 0.627-0.729; I(2) =0). In pooled analysis, the NNT for sildenafil, tadalafil, vardenafil and any PDE5 inhibitor was 2.4, 2.6, 4.1 and 3.0 respectively. The most common side effects were headache, flushing, and nasal congestion. CONCLUSIONS: PDE5 inhibitors are effective and safe medications for the treatment of sexual dysfunction in patients with diabetes mellitus experiencing erectile dysfunction.