The effectiveness and safety of avanafil for erectile dysfunction: a systematic review and meta-analysis

Abstract

Objective:

To compare the efficacy and safety between different dosages of avanafil for the treatment of erectile dysfunction (ED).

Methods:

PubMed, Cochrane Library, and Embase were searched to identify randomized controlled trials which compared avanafil with placebo, or compared different dosages of avanafil for ED. International Index of Erectile Function–Erectile Function domain score (IIEF-EF), Sexual Encounter Profile Question (SEP) questions 2 and 3, and adverse events were considered as the study outcomes. Both pairwise meta-analysis and network meta-analysis were carried out.

Results:

Five studies including 2225 patients were assessed. The pairwise meta-analysis suggested that avanafil was more effective than placebo in improving IIEF-EF (mean difference [MD]: 4.47; 95% confidence interval [CI]: 3.51 to 5.43), SEP-2 (MD: 17.41; 95% CI: 14.03 to 20.79), and SEP-3 (MD: 20.01; 95% CI: 22.98 to 37.22), with an evident dose–response relationship. The effectiveness was significantly different between the 50 mg and 100 mg groups, or between the 50 mg and 200 mg groups, for all outcomes. Overall, avanafil was associated with a significantly higher incidence of any adverse event (risk ratio [RR]: 2.56; 95% CI: 1.66 to 3.94), serious adverse event (RR: 2.78; 95% CI: 1.34 to 5.76), flushing (RR: 6.06; 95% CI: 3.37 to 10.88) and headache (RR: 7.54; 95% CI: 3.52 to 16.12) when compared with placebo. No significant difference in safety was found among various dosage groups.

Conclusions:

Avanafil, from 50 to 200 mg, is effective and well tolerated for the treatment of ED, and an increase in dosage is associated with a significant rise in effectiveness but not with significantly more adverse events.

Keywords::

• Avanafil
• Erectile dysfunction
• Meta-analysis
• Systematic reviews

Transparency

Declaration of funding

This study was not funded. Publication fees are being paid for by the authors.

Author contributions: conception and design: J.L.; selection and screening of trials included in the analysis: J.Y., X.H., K.T.; data extraction and analysis: H.W., J.Y., X.H.; writing paper: H.W., J.Y.; manuscript revision: D.H., J.L., H.W., and J.Y. contributed equally and should be considered co-first authors.

Declaration of financial/other relationships

H.W., J.Y., X.H., K.T., J.L., and D.H. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.