1519 VITAROS® EFFICACY AND SAFETY IN VIAGRA® NON-RESPONDERS WITH LONGER TERM USE

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Nonsurgical Therapy1 Apr 20131519 VITAROS® EFFICACY AND SAFETY IN VIAGRA® NON-RESPONDERS WITH LONGER TERM USE John Mulhall, Jacques Buvat, Irwin Goldstein, Bassam Damaj, Daniel Frank, and Ysabella Fernando John MulhallJohn Mulhall New York, NY More articles by this author , Jacques BuvatJacques Buvat Lille, France More articles by this author , Irwin GoldsteinIrwin Goldstein San Diego, CA More articles by this author , Bassam DamajBassam Damaj San Diego, CA More articles by this author , Daniel FrankDaniel Frank San Diego, CA More articles by this author , and Ysabella FernandoYsabella Fernando San Diego, CA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2997AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Vitaros® (alprostadil topical cream) is a novel erectogenic therapy, applied topically to the urethral meatus. The efficacy and safety of Vitaros®, was tested in erectile dysfunction (ED) patients in Phase 3 clinical trials including men who had previously taken the phosphodiesterase type 5 (PDE-5) inhibitor, Viagra®. Efficacy after twelve weeks and longer term use was evaluated to determine whether Vitaros® may sustain erectile function in men previously unresponsive to PDE-5 inhibitors. METHODS Initially, a twelve-week trial treated 1732 patients with placebo or three dose levels of Vitaros (100, 200, 300 mcg). Of these, 325 patients had a history of Viagra® use but discontinued due to no or low efficacy. Patients completed the international index of erectile function (IIEF) at multiple time points. Subsequently, an open-label flexible dose trial (planned for twelve months) enrolled the same patients to assess longer-term safety and efficacy. Patients were given eight doses of Vitaros® 200 mcg dose and then permitted to choose their dose for the remainder of the study. Of the 325 Viagra-failure patients, >70% continued in the open label trial. The IIEF erectile function (EF) domain score was compared between baseline and after twelve weeks of treatment and the patient's last visit in the open-label trial. Safety was evaluated in patients receiving at least one dose. RESULTS After twelve weeks, the mean change in IIEF EF domain score was greater for the treatment groups (ranging from 1.2-1.6 as compared to placebo (-0.9). This increase in the IIEF-EF was enhanced with longer treatment in the open-label trial. The dose most commonly chosen by the patients was 300 mcg. Although individual variability occurred, the IIEF-EF tended to increase with time, especially in those patients with IIEF-EF scores >10. The adverse events reported in this subset of patients were mild to moderate local reactions not markedly different from the overall trend in the remaining safety population. Additionally, the incidence of AE reports decreased with repeated exposure. CONCLUSIONS In general, Vitaros® 200 and 300 mcg doses showed improved erections in this population and adverse events were limited, decreasing with repeated exposure. Therefore, Vitaros® may be a viable treatment option for those patients previously unresponsive to PDE-5 inhibitors. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e622 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Mulhall New York, NY More articles by this author Jacques Buvat Lille, France More articles by this author Irwin Goldstein San Diego, CA More articles by this author Bassam Damaj San Diego, CA More articles by this author Daniel Frank San Diego, CA More articles by this author Ysabella Fernando San Diego, CA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...