Efficacy and safety of udenafil for erectile dysfunction: a meta-analysis of randomized controlled trials.

OBJECTIVE: To systematically review the evidence on the efficacy and safety of udenafil as treatment of erectile dysfunction from randomized controlled trials.

METHODS: We searched PubMed, Embase, and the Cochrane Library database up to October 2011. The outcome measures assessed were the change from baseline for the International Index of Erectile Function erectile function domain score (primary), the change from baseline for Sexual Encounter Profile questions 2 and 3, the shift to normal rate (erectile function domain ≥ 26), the response to the Global Assessment Questionnaire and adverse effects (secondary). Two of us independently assessed the study quality and extracted data. All data were analyzed using Review Manager, version 5.0.2.

RESULTS: Five randomized controlled trials totaling 1109 patients were included. At the follow-up endpoints, udenafil was found to be more effective than placebo, and the tolerability was good. The pooled results showed that the udenafil group was significantly greater than the placebo group in the change from baseline for the International Index of Erectile Function erectile function domain score (mean difference 5.65, 95% confidence interval 4.41-6.89, P < .00001). All included studies indicated that most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study period. The most common drug-related adverse events were flushing and headache (udenafil vs placebo, 5.6% vs 1.8% and 3.1% vs 0%, respectively).

CONCLUSION: The results from the current meta-analysis have suggested that udenafil is an effective and well-tolerated therapy for erectile dysfunction. The findings of the present review highlight the need for more efficient performance of higher quality, large-sample, various-race, long-term, randomized controlled trials to verify the efficacy and safety of udenafil.