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Ava3.6

Avanafil (Stendra) Research

Mostly mechanism / observationalModerate safety

6 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Avanafil (Stendra) studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from mixed-quality meta-analyses and randomised trials published 2012–2017.

Based on 6 studies · 1 meta-analysis · 2 RCTs

Confidence

Moderate

By outcome

Erectile function
Mostly mechanism / observational6 studies
Safety profile
Mostly mechanism / observational4 studies
Cardiovascular & vascular
Too few graded studies1 study

Older research base

Newest study from 2017 · Latest meta-analysis: 2014

20122017

1RCT2012

Avanafil significantly improved erectile function and was well tolerated across doses in men with erectile dysfunction.

Goldstein, McCullough, Jones, Hellstrom, Bowden, Didonato, Trask, Day · The Journal of Sexual Medicine (2012)

REVIVE: 12-week phase-3 double-blind, placebo-controlled RCT of on-demand avanafil (50, 100, 200 mg) in men with erectile dysfunction
Significant improvement on the IIEF erectile-function domain and per-attempt success versus placebo
Onset was rapid and the drug was well tolerated; common effects were headache, flushing, and nasal congestion

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2RCT2012

Avanafil significantly improved erectile function in men with diabetes mellitus and was generally well tolerated.

Goldstein, Jones, Belkoff, Karlin, Bowden, Peterson, Trask, Day · Mayo Clinic Proceedings (2012)

REVIVE-Diabetes: 12-week multicenter, randomized, double-blind RCT of avanafil in men with ED and diabetes mellitus
Significant improvement on the IIEF and per-attempt intercourse success versus placebo in a hard-to-treat population
Demonstrates efficacy in diabetic erectile dysfunction, where vascular and neuropathic disease blunt response

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3Meta-Analysis2014

Avanafil meaningfully improved erectile function versus placebo with a favorable tolerability profile.

Cui, Li, Zong, Yan, Zhang · Asian Journal of Andrology (2014)

Systematic review and meta-analysis pooling randomized placebo-controlled avanafil trials
Avanafil improved IIEF and successful-intercourse rates versus placebo across doses
Tolerability was favorable, with headache and flushing the most common adverse effects

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4Systematic Review2017

PDE5-inhibitor administration improved erectile-function recovery after bilateral nerve-sparing radical prostatectomy.

Limoncin, Gravina, Corona, Maggi, Ciocca, Lenzi, Jannini · Andrology (2017)

Systematic review with trial sequential analysis of placebo-controlled RCTs of PDE5 inhibitors (the avanafil class) after radical prostatectomy
PDE5-inhibitor treatment improved erectile-function recovery versus placebo in nerve-sparing surgery
Supports the role of the PDE5-inhibitor class in a major post-surgical ED population

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5Open-Label2013

Over 52 weeks, avanafil maintained efficacy with a favorable safety and tolerability profile.

Belkoff, McCullough, Goldstein, Jones, Bowden, DiDonato, Trask, Day · International Journal of Clinical Practice (2013)

52-week open-label extension of two 12-week phase-3 placebo-controlled trials
Sustained improvement in erectile function and successful-intercourse rates over a year of use
Confirms long-term tolerability of a rapidly absorbed, highly selective PDE5 inhibitor

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6Preclinical2014

Avanafil is a potent and highly selective PDE5 inhibitor (a pyrimidine-5-carboxamide derivative) with high selectivity over the other phosphodiesterase isozymes.

Sakamoto, Koga, Hikota, Matsuki, Murakami, Kikkawa, Fujishige, Kotera, Omori, Morimoto, Yamada · Bioorganic & Medicinal Chemistry Letters (2014)

Medicinal-chemistry account of the discovery of avanafil as a pyrimidine-5-carboxamide PDE5 inhibitor
Characterizes high PDE5 potency with high selectivity over PDE6 (retinal) and PDE1
Provides the mechanistic basis for fast onset and a potentially lower visual-side-effect profile than sildenafil

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View in Research Library

Avanafil (Stendra) Research

Mostly mechanism / observational

A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction.

Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus.

Avanafil for male erectile dysfunction: a systematic review and meta-analysis.

Erectile function recovery in men treated with phosphodiesterase type 5 inhibitor administration after bilateral nerve-sparing radical prostatectomy: a systematic review of placebo-controlled randomized trials with trial sequential analysis.

An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction.

The discovery of avanafil for the treatment of erectile dysfunction: a novel pyrimidine-5-carboxamide derivative as a potent and highly selective phosphodiesterase 5 inhibitor.