title: The safety and efficacy of Avanafil, a new 2(nd) generation PDE5i: comprehensive review and meta-analysis.
abstract: BACKGROUND
  The discontinuation rate with phosphodiesterase type 5 inhibitors (PDE5i) remains very high. Recently, a new PDE5ì, avanafil, has become available worldwide.
  
  
  METHODS
  All placebo-controlled randomized clinical trials (RCTs) on the effect of avanafil in patients with ED were reviewed and meta-analyzed. So far, 5 different RCTs on avanafil have been published, including 1379 and 605 patients in active and placebo groups, respectively. Avanafil was up to 3-fold superior to placebo in determining successful sexual intercourse. Although head-to-head comparative studies are still lacking, re-analyses of available data, showed that avanafil had comparable efficacy, but lower incidence of drug-related side effects, compared to first-generation PDE5is.
  
  
  CONCLUSIONS
  Avanafil specific and peculiar pharmacological profile, addresses several problems that have been documented with first-generation PDE5is. Avanafil should theoretically guarantee a low dropout incidence by ensuring a natural profile of action and a low incidence of side effects. Longer studies and head-to-heard trials are advisable to clarify these issues.
authors.affiliation: a Endocrinology Unit, Maggiore-Bellaria Hospital, Medical Department , Azienda-Usl Bologna , Bologna , Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Corona
authors.affiliation: b Sexual Medicine and Andrology Unit, Department of Experimental, Clinical and Biomedical Sciences , University of Florence , Florence , Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Rastrelli
authors.affiliation: c Department of Psychology , University of Zurich , Zurich , Switzerland.
authors.forename: Andrea
authors.initials: A
authors.lastname: Burri
authors.affiliation: d Endocrinology, Andrology and Medical Sexology, Department of Systems Medicine , Tor Vergata University of Rome , Rome , Italy.
authors.forename: Emmanuele A
authors.initials: EA
authors.lastname: Jannini
authors.affiliation: b Sexual Medicine and Andrology Unit, Department of Experimental, Clinical and Biomedical Sciences , University of Florence , Florence , Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Maggi
mesh_terms: D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D058986:Phosphodiesterase 5 Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; C553414:avanafil
keywords: Avanafil; PDE5i; dropout; side effects