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

Belkoff, Laurence; McCullough, Andrew; Goldstein, Irwin; Jones, L.; Bowden, C. H.; DiDonato, Karen; Trask, Brenda; Day, Wesley W.

doi:10.1111/ijcp.12065

Cited by 50 publications

(57 citation statements)

References 16 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: 78%

“…Interestingly, only three subjects (0.4%) requested that their avanafil dose be decreased, confirming the good safety profile of this PDE5i. [25] Accordingly, the results provided by our meta-analysis showed that avanafil 100 and 200 mg were well tolerated and not associated with any increased risk of serious adverse events, in comparison with placebo. In addition, no risk of discontinuation of avanafil therapy due to drug-related adverse events was observed.…”

Section: Results Evaluationmentioning

confidence: 64%

“…Accordingly, avanafil long-term monitoring data have shown that only a minority of subjects requested dosage reduction due to drug-related adverse events. [25] In fact, ED is frequently associated with low self-esteem, especially regarding sexual performance capability. [32] Hence, starting with a lower dosage might not allow reaching satisfactory results, further enhancing low self-esteem and drug discontinuation.…”

Section: Expert Opinionmentioning

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: 78%

Section: Results Evaluationmentioning

confidence: 64%

Section: Expert Opinionmentioning

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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“…There was no restriction with regard to the intake of the drug together with food or alcohol; patients who were on alpha-blocker medication were not excluded from the study. [Belkoff et al 2011]. There were no serious drug-related adverse events.…”

Section: Basic Research Findingsmentioning

confidence: 99%

Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties

Kedia

Ückert

Assadi-Pour

et al. 2012

Therapeutic Advances in Urology

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Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical management of erectile dysfunction (ED) of various etiologies and severities. However, a significant number of patients remain dissatisfied with the available therapies due a lack of efficacy or discomfort arising from adverse events. Several new PDE5 inhibitors, among which are avanafil (TA-1790), lodenafil, mirodenafil, udenafil, SLX-2101, JNJ-10280205 and JNJ-10287069, have recently been approved and introduced into the market or are in the final stages of their clinical development. Avanafil (marketed in the US under the brand name STENDRA TM ) has been developed by VIVUS Inc. (Mountain View, CA, USA) and has recently received approval from the US Food and Drug Administration (FDA) for use in the treatment of male ED. The drug has demonstrated improved selectivity for PDE5, is rapidly absorbed after oral administration with a fast onset of action and a plasma half-life that is comparable to sildenfil and vardenafil. In phase II and phase III clinical trials that included a large number of patients, avanafil has been shown to be effective and well tolerated. Owing to its favorable pharmacodynamic and pharmacokinetic profile, avanafil is considered as a promising new option in the treatment of ED. The present article summarizes the initial data and clinical key properties of avanafil.

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“…228 There are three level 1 studies 20,24,229 and one open-label extension study (level 2) that have confirmed the sustained efficacy and safety of avanafil for 1 year. 230 The overall grade of recommendation is A.…”

Section: Avanafilmentioning

confidence: 99%

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

Hatzimouratidis

Salonia

Adaikan

et al. 2016

The Journal of Sexual Medicine

177

199

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Introduction Treatment of erectile dysfunction is based on pharmacotherapy for most patients. Aim To review the current data on pharmacotherapy for erectile dysfunction based on efficacy, psychosocial outcomes, and safety outcomes. Methods A review of the literature was undertaken by the committee members. All related articles were critically analyzed and discussed. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) are provided based on a thorough analysis of the literature and committee consensus. Results Ten recommendations are provided. (i) Phosphodiesterase type 5 (PDE5) inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction (LE = 1, GR = A). (ii) There are no significant differences in efficacy, safety, and tolerability among PDE5 inhibitors (LE = 1, GR = A). (iii) PDE5 inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use (LE = 3, GR = C). (iv) Intracavernosal injection therapy with alprostadil is an effective and well-tolerated treatment for men with erectile dysfunction (LE = 1, GR = A). (v) Intracavernosal injection therapy with alprostadil should be offered to patients as second-line therapy for erectile dysfunction (LE = 3, GR = C). (vi) Intraurethral and topical alprostadil are effective and well-tolerated treatments for men with erectile dysfunction (LE = 1, GR = A). (vii) Intraurethral and topical alprostadil should be considered second-line therapy for erectile dysfunction if available (LE = 3, GR = C). (viii) Dose titration of PDE5 inhibitors to the maximum tolerated dose is strongly recommended because it increases efficacy and satisfaction from treatment (LE = 2, GR = A). (ix) Treatment selection and follow-up should address the psychosocial profile and the needs and expectations of a patient for his sexual life. Shared decision making with the patient (and his partner) is strongly recommended (LE = 2, GR = A). (x) Counterfeit medicines are potentially dangerous. It is strongly recommended that physicians educate their patients to avoid taking any medication from unauthorized sources (LE = 2, GR = A). The first seven recommendations are the same as those from the Third International Consultation for Sexual Medicine and the last three are new recommendations. Conclusion PDE5 inhibitors remain a first-line treatment option because of their excellent efficacy and safety profile. This class of drugs is continually developed with new molecules and new formulations. Intracavernosal injections continue to be an established treatment modality, and intraurethral and topical alprostadil provide an alternative, less invasive treatment option.

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

Abstract: The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.

Cited by 50 publications

References 16 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

Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

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

Abstract: The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.

Cited by 50 publications

References 16 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

Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

Contact Info

Product

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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