Avanafil for the treatment of erectile dysfunction. An updated review.

OBJECTIVES: Avanafil is a highly selective phosfosdiesterase 5 inhibitor (PDE5 inhibitor), with rapid onset of action, approved by the Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of erectile dysfunction (ED). It had been recently commercialized in Spain. This article presents a detailed review of the available literature, where the safety, tolerability and efficacy of avanafil were evaluated.

METHODS: A systematic literature search using the Medline database was performed. The search included the terms Avanafil and erectile dysfunction. The pivotal studies of clinical development of the drug, and also those randomized, double-blind, placebo-controlled, well-designed studies were analyzed. We included those studies published in English up to January 2014. Likewise, studies of the pharmacokinetics and pharmacodynamics of the drug were also included.

RESULTS: The avanafil pivotal studies, conducted in general population of patients with ED, patients with Diabetes mellitus type I and II and patients with ED secondary to nerve sparing radical prostatectomy were analyzed. In all these studies, avanafil demonstrated a statistically significant improvement in erectile function (IIEF), and all the coprimary outcomes (SEP2 and SEP3) compared to placebo. Also, a good tolerance profile and few side effects compared to placebo were evident.

CONCLUSIONS: Avanafil is a selective PDE5 inhibitors, that is rapidly absorbed and that has a short time to peak response. It found to be effective in randomized, double-blind, placebo-controlled trials conducted in men with erectile dysfunction, including in patients with diabetes mellitus and after radical prostatectomy. It was generally well tolerated across trials, with very few patients withdrawing because of adverse effects. Similarly, avanafil had a significantly lower rate of hemodynamic side effects compared with sildenafil.