A Phase 3, Placebo Controlled Study of the Safety and Efficacy of Avanafil for the Treatment of Erectile Dysfunction After Nerve Sparing Radical Prostatectomy

Published on Jun 1, 2013in The Journal of Urology7.45
· DOI :10.1016/J.JURO.2012.11.177
John P. Mulhall79
Estimated H-index: 79
(MSK: Memorial Sloan Kettering Cancer Center),
Arthur L. Burnett85
Estimated H-index: 85
(Johns Hopkins University)
+ 6 AuthorsWesley W. Day10
Estimated H-index: 10
Sources
Abstract
Purpose: We evaluated the safety and efficacy of 100 and 200 mg avanafil for the treatment of adult males with erectile dysfunction after bilateral nerve sparing radical prostatectomy.Materials and Methods: This was a double-blind, placebo controlled, parallel group, phase 3 study in males age 18 to 70 years with a history of erectile dysfunction of 6 months or more after bilateral nerve sparing radical prostatectomy. Patients were randomized to 100 or 200 mg avanafil or placebo (taken 30 minutes before sexual activity) for 12 weeks. Primary end points included successful vaginal insertion (Sexual Encounter Profile [SEP] question 2), successful intercourse (SEP3) and change in score on the erectile function domain of the International Index of Erectile Function (IIEF-EF) questionnaire.Results: A total of 298 patients were randomized and 84.6% completed the study. At baseline 16.1% were age 65 years or older and 71.5% had severe erectile dysfunction (mean overall IIEF-EF domain score 9.2). After 12 weeks t...
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Summary Aim: Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. Methods: This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; ‘100/200-mg’ group) or 50 mg (for improved toler...
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#1Wayne J. G. Hellstrom (University Medical Center New Orleans)H-Index: 14
#2Matthew T. Freier (University Medical Center New Orleans)H-Index: 1
Last. Craig A. PetersonH-Index: 13
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What's known on the subject? and What does the study add? Phosphoesterase type 5 inhibitors (PDE5is) are considered standard-of-care for the treatment of men with erectile dysfunction. Recommended administration of currently used PDE5is are between 60- to 120-minutes before sexual activity. RigiScan® monitoring has been validated in previous clinical studies of PDE5 inhibitors. Using a highly objective measure of sexual function (RigiScan monitoring), data show that the onset of action of avanaf...
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#1Irwin GoldsteinH-Index: 81
#2LeRoy JonesH-Index: 11
Last. Wesley W. DayH-Index: 10
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Objective: To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus. Patients and Methods: This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n129), avanafil, 200 mg (n131), or placebo (n130). Coprimary end points ...
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#1Run Wang (University of Texas MD Anderson Cancer Center)H-Index: 33
#2Arthur L. Burnett (Johns Hopkins University)H-Index: 85
Last. Craig A. PetersonH-Index: 13
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ABSTRACT Introduction Phosphodiesterase type 5 (PDE5) inhibitors are indicated for the treatment of erectile dysfunction (ED); however, they can also inhibit other PDE isozymes, affecting their target tissues (e.g., PDE1: heart; PDE6: retina; and PDE11: skeletal muscle), which in some cases can cause unwanted side effects and therapy discontinuation. Data from in vitro studies showed that avanafil, a PDE5 inhibitor for the treatment of ED, exhibited strong selectivity toward PDE5 and against all...
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#1Jun Kotera (Mitsubishi Tanabe Pharma)H-Index: 28
#2Hideki Mochida (Mitsubishi Tanabe Pharma)H-Index: 7
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Purpose: We investigated the in vitro inhibitory effects of avanafil, a novel, potent inhibitor of phosphodiesterase-5, on 11 phosphodiesterases. We also studied its potentiation of penile tumescence in dogs.Materials and Methods: Phosphodiesterase assay was done with the 4 phosphodiesterase-5 inhibitors avanafil, sildenafil, vardenafil and tadalafil using 11 phosphodiesterase isozymes. In anesthetized dogs the pelvic nerve was repeatedly stimulated to evoke tumescence. Intracavernous pressure w...
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#1Irwin GoldsteinH-Index: 81
#2Andrew McCulloughH-Index: 32
Last. Wesley W. DayH-Index: 1
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ABSTRACT Introduction Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED). Aim To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED. Methods In this multicenter, double‐blind, Phase 3 trial, 646 subjects were randomized to receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout a 12‐week treatment period. Subjects were instructed to take study drug 30 minutes prior to initia...
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#1Andrea Gallina (UniSR: Vita-Salute San Raffaele University)H-Index: 62
#2Matteo Ferrari (UniSR: Vita-Salute San Raffaele University)H-Index: 18
Last. Alberto Briganti (UniSR: Vita-Salute San Raffaele University)H-Index: 99
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ABSTRACT Introduction Several studies have shown that erectile function (EF) recovery in patients undergoing bilateral nerve sparing radical prostatectomy (BNSRP) improves significantly when phosphodiesterase type 5 inhibitors (PDE5) are administered following surgery. Aim The aim of this article was to identify patients who may recover EF after retropubic BNSRP (BNSRRP) without PDE5. Methods We included 293 patients treated with BNSRRP at a single center. Postoperative EF recovery was defined a...
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#1Andre B. AraujoH-Index: 50
#2Kerstin R. AllenH-Index: 3
Last. Raymond C. RosenH-Index: 129
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ABSTRACT Introduction Despite adoption of the successful vaginal insertion (Q2) and intercourse (Q3) items of the sexual encounter profile (SEP) as end points in clinical trials, there are no objective data on what constitute minimal clinically important differences (MCIDs) in these items. Aim The objective was to estimate the MCID for SEP Q2 and Q3. Methods Using data from 17 randomized, controlled trials of the phosphodiesterase type 5 inhibitor tadalafil, we estimated MCIDs for the SEP using ...
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#1Raymond C. RosenH-Index: 129
#2Kerstin R. AllenH-Index: 3
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Abstract Background Despite widespread adoption of the six-item erectile function (EF) domain of the International Index of Erectile Function (IIEF) as a clinical trial end point, there are currently no objective data on what constitutes a minimal clinically important difference (MCID) in the EF domain. Objective Estimate the MCID for the IIEF EF domain. Design, setting, and participants Anchor-based MCIDs were estimated using data from 17 randomized, double-blind, placebo-controlled, parallel-g...
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#1Daphné Vanderhaeghe (Katholieke Universiteit Leuven)H-Index: 1
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Erectile dysfunction is commonly reported after radical prostatectomy. Besides the loss of erections, sexual life after prostatectomy is impacted by urinary incontinence, orgasmic dysfunction, and psychological stress. In this review, we describe classical medical therapies used for erectile function rehabilitation such as PDE5 inhibitors and injection therapy. A vast amount of data support the idea of focusing on restoration of sexual function on top of erectile function after prostatectomy. Th...
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#1Hui Jiang (PKU: Peking University)H-Index: 12
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INTRODUCTION The incidence of erectile dysfunction (ED) increases with age in mainland China and phosphodiesterase 5 inhibitors (PDE5i) are the major drugs used for its treatment. AIM To determine the efficacy and safety of Chinese developed avanafil as therapy for ED in China. METHODS This phase III trial was carried out in 7 medical centers in China. Eligible subjects suffering from ED were allocated randomly into 3 groups (ratio 1:1:1) and orally received a placebo, 100 or 200 mg avanafil for...
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OBJECTIVE: To investigate the impact of penile rehabilitation on the recovery of erectile function after robot-assisted radical prostatectomy. METHODS: Patients who underwent robot-assisted radical prostatectomy in our department from 2010 to 2019 were included. For penile rehabilitation, a phosphodiesterase-5 inhibitor (tadalafil 20 mg) was administered twice a week for 1-6 months postoperatively. The International Index of Erectile Function questionnaire (question 1 and erectile function domai...
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#1Melianthe P. J. Nicolai (NKI-AVL: Netherlands Cancer Institute)H-Index: 11
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After radical prostatectomy (RP) or radiotherapy (RT) for prostate cancer, erectile dysfunction (ED) is the main complication, highly effecting quality of life. The pathophysiology of ED after these treatments is believed to include neuropraxia causing reduced oxygenation and structural changes of the tissue in the corpora cavernosa. Next to the option of sparing the nerves during RP, research have been focusing on methods for penile rehabilitation after RP and RT, since it occurs often, even af...
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#2Zhongyu Jian (Sichuan University)H-Index: 1
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BACKGROUND To verify which phosphodiesterase type 5 inhibitors (PDE5is) strategy is better for erectile dysfunction (ED) following nerve-sparing radical prostatectomy (NSRP). METHODS This systematic literature search was conducted in MEDLINE, Web of Science and Cochrane Central Register of Controlled Trials database to identify eligible studies from the startup of these databases to 1 November, 2019. The ED recovery rate was the main outcome. Traditional pair-wise meta-analysis and multivariate ...
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#1Chengquan Ma (Peking Union Medical College Hospital)H-Index: 3
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#1Arjun Nathan (University of Cambridge)H-Index: 1
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To assess whether the timing of post-operative Phosphodiesterase Inhibitor (PDE5i) therapy after Robot-Assisted Radical Prostatectomy (RARP) is associated with a change in early erectile function (EF) outcomes, continence or safety outcomes. Data were prospectively collected from a single surgeon in one tertiary centre. 158 patients were treated with PDE5i therapy post RARP over a 2-year period. PDE5i therapy was started: immediately (day 1-2) post-op in 29%, early (day 3-14) post-op in 37% and ...
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#1Abdelaal M. Elkamshoushi (Alexandria University)H-Index: 3
#2Noha Mohamed Badae (Alexandria University)H-Index: 4
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Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor. However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the endothelial markers' serum level and erectile function in patients with erectile dysfunction. In this work, we randomly divided 140 males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction like diabetes me...
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#1Dechao FengH-Index: 4
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Background We aim to present a comprehensive comparison of various treatments in the management of penile recovery after radical prostatectomy (RP) and provide recommendations for future research. Methods Literature search of electronic databases including PubMed, the Cochrane Library, Embase, PsycInfo, and Web of Science, and manual retrieval were conducted from inception through March 2020. "Erectile dysfunction" and "prostatectomy" were used as the Mesh terms. The patients, intervention, comp...
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#1Riccardo LombardoH-Index: 14
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Background Phosphodiesterase 5 inhibitors (PDE5I) represent the first line treatment in the management of post-operative erectile dysfunction (ED) after pelvic oncological surgery. Aim of our study is to evaluate the available evidence on the efficacy of PDE5Is including new formulations and penile rehabilitation post-pelvic surgery. Evidence acquisition A systematic review of the literature was performed until May 2020. The following databases were searched: Scopus, Medline and Web of Science. ...
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