Avanafil for the Treatment of Erectile Dysfunction: A Multicenter, Randomized, Double-Blind Study in Men With Diabetes Mellitus

Goldstein, Irwin; Jones, L.; Belkoff, Laurence; Karlin, Gary S.; Bowden, C. H.; Peterson, Craig A.; Trask, Brenda; Day, Wesley W.

doi:10.1016/j.mayocp.2012.06.016

Cited by 78 publications

(78 citation statements)

References 34 publications

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“…Present data were confirmed by Belkoff et al [25] in a 52-week, open-label extension of two placebo-controlled RCTs [15,20] including 712 subjects with or without diabetes. All patients in this preplanned extension trial were initially assigned to treatment with avanafil 100 mg.…”

Section: Results Evaluationsupporting

confidence: 74%

“…The authors reported data of four placebo-controlled RCTs, [19][20][21] showing that avanafil was superior to placebo in improving vaginal penetration and successful intercourse. [18] However, in that study only a comparison of avanafil 100 mg versus placebo was considered.…”

Section: Clinical Efficacymentioning

confidence: 99%

“…[22] Hence, so far, five different doubleblind, placebo-controlled RCTs on avanafil have been published. In particular, three of them were performed in the general population [15,19,22] and one in diabetic subjects [20] or in those treated with radical prostatectomy, [21] respectively. To better evaluate the safety and efficacy of avanafil 100 and 200 mg over placebo, we decided to perform a new meta-analysis of all available RCTs.…”

Section: Clinical Efficacymentioning

confidence: 99%

“…All placebo-controlled randomized clinical trials (RCTs) on the effect of avanafil in patients with ED were reviewed and meta-analyzed without any arbitrary restriction [19][20][21][22]; see also Tables 3-4.…”

Section: Search Strategy and Study Selectionmentioning

confidence: 99%

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

Corona

Rastrelli

Burri

et al. 2016

Expert Opinion on Drug Safety

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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. ARTICLE HISTORY

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Section: Results Evaluationsupporting

confidence: 74%

Section: Clinical Efficacymentioning

confidence: 99%

Section: Clinical Efficacymentioning

confidence: 99%

Section: Search Strategy and Study Selectionmentioning

confidence: 99%

See 2 more Smart Citations

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

Corona

Rastrelli

Burri

et al. 2016

Expert Opinion on Drug Safety

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“…Ten studies were excluded from the final analysis as they did not fulfill inclusion criteria. One RCT was excluded from the analysis as it studied the efficacy and safety of a new PDE5i (Avanafil) in diabetic patients, but it did not analyze endothelial function (39). Two RCTs were excluded as they provided an evaluation of endothelial function after acute rather than chronic treatment with a PDE5i and because of quasi-randomization (40,41).…”

Section: Data Synthesis and Analysismentioning

confidence: 99%

THERAPY OF ENDOCRINE DISEASE: Effects of chronic use of phosphodiesterase inhibitors on endothelial markers in type 2 diabetes mellitus: a meta-analysis

Santi

Giannetta

Isidori

et al. 2015

European Journal of Endocrinology

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Objective: Diabetes mellitus (DM) is associated with endothelial dysfunction, reducing nitric oxide-dependent vasodilation, and increasing production of pro-inflammatory factors, leading to an increased risk of long-term cardiovascular disease. As the effects of phosphodiesterase 5 inhibitors (PDE5i) on endothelial function have not been systematically investigated, we conducted a meta-analysis of available randomized clinical trials (RCTs). Design: A thorough search of the literature was carried out. Relevant studies were considered according to RCT study design, enrollment of men with type 2 DM, chronic administration of PDE5i, and evaluation of endothelial function through both hemodynamic and endothelial inflammation-related parameters. Results: Fifteen studies fulfilled the eligibility criteria but only six RCTs met the inclusion criteria and were analyzed for 476 diabetic men, 239 randomized to Sildenafil, and 237 to placebo respectively. Four RCTs evaluated flow-mediated dilation (FMD), demonstrating a weighted mean increase of 2.19% (95% CI 0.48 to 3.90). This result showed a high heterogeneity (I 2 : 98%). Thus, a further sub-group meta-analysis was performed and this analysis confirmed a significant, Sildenafil-related FMD improvement. Sildenafil improved endothelin 1 and high sensitivity C-reactive protein by wK0.94 pg/ml and K0.36 mg/l, respectively, not reaching statistical significance (PZ0.69 and PZ0.22 respectively). Finally, Sildenafil administration significantly reduced serum levels of interleukin 6 (IL6, K0.82 pg/ml; 95% CI K1.58 to K0.07). Conclusion: This meta-analysis suggests a beneficial effect of chronic PDE5i administration on endothelial function. Chronic Sildenafil administration seems to improve hemodynamic (FMD) and serum pro-inflammatory makers (IL6) in diabetic men. Larger studies are needed to confirm the effects of chronic PDE5i on endothelial function.

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Sexual Function in Men and Women with Diabetes

Price

2016

Textbook of Diabetes

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Avanafil for the Treatment of Erectile Dysfunction: A Multicenter, Randomized, Double-Blind Study in Men With Diabetes Mellitus

Abstract: clinicaltrials.gov Identifier NCT00809471.

Cited by 78 publications

References 34 publications

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

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

THERAPY OF ENDOCRINE DISEASE: Effects of chronic use of phosphodiesterase inhibitors on endothelial markers in type 2 diabetes mellitus: a meta-analysis

Sexual Function in Men and Women with Diabetes

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Avanafil for the Treatment of Erectile Dysfunction: A Multicenter, Randomized, Double-Blind Study in Men With Diabetes Mellitus

Abstract: clinicaltrials.gov Identifier NCT00809471.

Cited by 78 publications

References 34 publications

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

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

THERAPY OF ENDOCRINE DISEASE: Effects of chronic use of phosphodiesterase inhibitors on endothelial markers in type 2 diabetes mellitus: a meta-analysis

Sexual Function in Men and Women with Diabetes

Contact Info

Product

Resources

About

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

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