The safety and efficacy of Avanafil, a new 2 nd generation PDE5i: comprehensive review and meta-analysis

Corona, Giovanni; Rastrelli, Giulia; Burri, Andrea; Jannini, Emmanuele A.; Maggi, Mario

doi:10.1517/14740338.2016.1130126

Cited by 71Sexual function and dysfunction studiesPhosphodiesterase function and regulationUrological Disorders and Treatments

The safety and efficacy of Avanafil, a new 2 nd generation PDE5i: comprehensive review and meta-analysis

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Corona, Giovanni, Rastrelli, Giulia, Burri, Andrea, Jannini, Emmanuele A., Maggi, Mario·2016·Expert Opinion on Drug Safety

DOI 10.1517/14740338.2016.1130126

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Abstract

INTRODUCTION: The discontinuation rate with phosphodiesterase type 5 inhibitors (PDE5i) remains very high. Recently, a new PDE5ì, avanafil, has become available worldwide. AREAS COVERED: 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. EXPERT OPINION: 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.

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The most recent phosphodiesterase type 5 inhibitor on the market, avanafil, increases IIEF-EFD by 5 points in meta-analysis.
“They found that on average physical activity increased IIEF-EFD by almost 4 points, an effect that is not very far from the 5 point increase - as evaluated in the meta-analysis - by the most recent phosphodiesterase type 5 inhibitor (PDE5i) on the market, avanafil [59].”
From Treatment of Functional Hypogonadism Besides Pharmacological Substitution (2020) · cites this paper as [59]
On average, physical activity increased IIEF-EFD by almost 4 points in randomized controlled trials of ED patients.
“They found that on average physical activity increased IIEF-EFD by almost 4 points, an effect that is not very far from the 5 point increase - as evaluated in the meta-analysis - by the most recent phosphodiesterase type 5 inhibitor (PDE5i) on the market, avanafil [59].”
From Treatment of Functional Hypogonadism Besides Pharmacological Substitution (2020) · cites this paper as [59]

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Authors: Corona, G., Rastrelli, G., Burri, A., Jannini, E. A., & Maggi, M.
Affiliations: Azienda USL di Bologna (IT)
University of Florence (IT)
University of Zurich (CH)
University of Rome Tor Vergata (IT)
Corresponding author: Corona, Giovanni
ORCID: Corona, Giovanni
Rastrelli, Giulia
Burri, Andrea
Jannini, Emmanuele A.
Maggi, Mario
Venue: Expert Opinion on Drug Safety
Publisher: Informa UK Limited
Published: 2016-01-20
Volume: 15
Issue: 2
Pages: 237-247
ISSN: 1474-0338 (ISSN-L)
1744-764X
DOI: 10.1517/14740338.2016.1130126
OpenAlex: W2194710343
Cited by: 71
References: 59
Citations by year: 2026: 6 · 2025: 4 · 2024: 9 · 2023: 6 · 2022: 7 · 2021: 4 · 2020: 7 · 2019: 10 · 2018: 7 · 2017: 3 · 2016: 8
FWCI: 4.87
Type: journal article
Language: en
Update notices: correction (2016-02-16)
Open access: bronze
doi.org
Locations: Expert Opinion on Drug Safety (publishedVersion)
PubMed (publishedVersion)
Zurich Open Repository and Archive (University of Zurich) (acceptedVersion)
Florence Research (University of Florence) (submittedVersion)
Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Phosphodiesterase function and regulation
Health Sciences › Medicine › Urology › Urological Disorders and Treatments
Keywords: avanafil, phosphodiesterase-5 inhibitors, erectile dysfunction, drug efficacy, drug safety, adverse drug reactions, treatment discontinuation
MeSH terms: Humans, Erectile Dysfunction, Male, Pyrimidines, Randomized Controlled Trials as Topic, Phosphodiesterase 5 Inhibitors

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The safety and efficacy of Avanafil, a new 2 nd generation PDE5i: comprehensive review and meta-analysis

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