Pd45-12 Avanafil Efficacy Within 15 Minutes of Dosing in Men With Mild to Severe Erectile Dysfunction by Demographic and Baseline Clinical Characteristics

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You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy II1 Apr 2015PD45-12 AVANAFIL EFFICACY WITHIN 15 MINUTES OF DOSING IN MEN WITH MILD TO SEVERE ERECTILE DYSFUNCTION BY DEMOGRAPHIC AND BASELINE CLINICAL CHARACTERISTICS Laurence H. Belkoff, James P. Tursi, Jonathan Uy, Ted M. Smith, and LeRoy A. Jones Laurence H. BelkoffLaurence H. Belkoff More articles by this author , James P. TursiJames P. Tursi More articles by this author , Jonathan UyJonathan Uy More articles by this author , Ted M. SmithTed M. Smith More articles by this author , and LeRoy A. JonesLeRoy A. Jones More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2584AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We examined the efficacy of avanafil, a phosphodiesterase type 5 (PDE5) inhibitor approved for the treatment of erectile dysfunction (ED), within 15 minutes of dosing in subgroups of study subjects defined by: baseline ED severity (mild [International Index of Erectile Function (IIEF)-EF domain score 17-25], moderate, [IIEF score 11-16], severe [IIEF score ≤10]); age category (<50 years, 50-64 years, ≥65 years); race (White, Black/African American, Other); ED duration prior to study entry (<24 months, 24-59 months, ≥60 months); and diabetes status (diabetes, no diabetes). METHODS This double-blind, phase 4 study randomized 440 men ≥18 years old with a history of mild to severe ED of ≥6 months' duration, to placebo, avanafil 100 mg, or avanafil 200 mg (1:1:1). The primary efficacy variable was the per-subject proportion of all sexual attempts within the 8-week treatment period in which subjects obtained an erection sufficient for vaginal penetration within approximately 15 minutes after dosing (≤17 minutes and 59 seconds) and that enabled successful completion of sexual intercourse. Treatment by subgroup-level interactions were tested for the primary efficacy variable using an ANCOVA model. RESULTS No significant interactions between treatment groups and subgroup levels were observed for baseline ED severity, age category, race, or duration of ED prior to study entry. Least squares mean per-subject percentages (model-adjusted) of successful intercourse attempts within 15 minutes after dosing for the placebo, avanafil 100 mg, and avanafil 200 mg groups were: 24.0, 18.2, and 17.8, respectively, for subjects with diabetes, and 13.8, 27.9, 32.2, respectively for subjects without (interaction term p value = 0.026; Figure). The 3 most common treatment-emergent adverse events overall were headache, upper respiratory tract infection, and nasal congestion. CONCLUSIONS The effects of avanafil treatment were not impacted by baseline ED severity, age category, race, or duration of ED prior to study entry. The significant interaction between treatment effect and diabetes status may have been driven by a greater placebo response in subjects with vs without diabetes and was likely due to chance. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e906 Peer Review Report Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laurence H. Belkoff More articles by this author James P. Tursi More articles by this author Jonathan Uy More articles by this author Ted M. Smith More articles by this author LeRoy A. Jones More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...