MP43-20 ENDOTHELIAL DYSFUNCTION IN PATIENTS OF ERECTILE DYSFUNCTION USING SHORT-TERM LOW DOSE TADALAFIL : A DOUBLE BLIND RANDOMIZED CONTROL TRIAL

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Evaluation I1 Apr 2015MP43-20 ENDOTHELIAL DYSFUNCTION IN PATIENTS OF ERECTILE DYSFUNCTION USING SHORT-TERM LOW DOSE TADALAFIL : A DOUBLE BLIND RANDOMIZED CONTROL TRIAL Ravimohan Mavuduru, Pawan Kundal, Smita Pattanaik, Shrawan Singh, and Arup Mandal Ravimohan MavuduruRavimohan Mavuduru More articles by this author , Pawan KundalPawan Kundal More articles by this author , Smita PattanaikSmita Pattanaik More articles by this author , Shrawan SinghShrawan Singh More articles by this author , and Arup MandalArup Mandal More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1627AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Flow mediated dilatation (FMD) of brachial artery is a noninvasive measurement of Endothelial dysfunction EnD. Studies have shown low dose Tadalafil improves (EnD), however placebo controlled RCTs are lacking. METHODS This DB-RCT was conducted in accordance with the principles of Declaration of Helsinki and was approved by Institutional Ethics Committee. ED and EnD were assessed by self-administered IIEF-5 questionnaire and FMD respectively at baseline and 4 weeks by the same observer. Patients with FMD of < 15% were included. patients with history of PDEI intake in the past were excluded. Patients were randomized in 1:1 ratio to receive either placebo or tadalafil by a computer generated randomization list. Both placebo and tadalafil in tablet form were dispensed in bottles with dosage for 4weeks by a co-investigator who was not involved in the process of selection or evaluation of the end points to ensure complete blinding. Compliance was assessed by checking the empty drug bottles. Any drug related events during the study were recorded. The randomization codes were decoded at study completion. Appropriate statistical tests were applied. RESULTS Of 96 patients, 89 were randomized, and 82 completed the study, 41 in each group. Demographic profile, baseline IIEF-5 score and FMD % were comparable. Post-treatment there were significant improvements in IIEF-5 score (Pre vs Post treatment; Tadalafil: - 11.4±3.2vs 15.9±3.7, p <0.001 and placebo: 11.2±3.2 vs 14.9±3.5, p <0.001, respectively ) and FMD % (Pre vs Post treatment; Tadalafil: 11.2±2.2 vs 13.8±2.7, p <0.001 and placebo: 11.6±1.7vs 14.0±2.7, p <0.001, respectively) and this change was significant in all the sub-groups (based on IIEF-5 severity categorization). Inter-group comparison did not show any significant difference in IIEF scores (Mean change in IIEF-5 scores, Tadalafil vs Placebo: 3.7±1.9 vs 4.4 ± 3.3, p=0.223) and FMD % (Mean change in FMD%, Tadalafil vs Placebo: 2.4 ± 2.6 and 2.8 ± 2.9, p=0.528) This was true across all the subgroups except in patients with severe ED, where tadalafil group showed a significant improvement in FMD %.( Mean change in FMD%, Tadalafil vs Placebo: 4.6 ± 1.9 vs 1.6 ± 1.4, p=0.020 ). The adverse events were significantly more in Tadalafil group (Tadalafil vs placebo 14 ADR vs 5 ADR, p<0.001) CONCLUSIONS The response of low dose tadalafil (10mg per day) on IIEF and FMD is largely similar to placebo especially in young patients, however to draw meaningful conclusions, utility of FMD % in young patients and placebo effect a longer study need to be seen. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e525-e526 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ravimohan Mavuduru More articles by this author Pawan Kundal More articles by this author Smita Pattanaik More articles by this author Shrawan Singh More articles by this author Arup Mandal More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...