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Efficacy and Safety of DP-R202 in Patients with Chronic Artery Occlusive Disease: Multicenter Randomized Double-blind Active-controlled Parallel Group Phase III Clinical Study.

Authors
 Han Cheol Lee  ;  Sang-Rok Lee  ;  Kyoo-Rok Han  ;  Cheol-Woong Yu  ;  Chang-Gyu Park  ;  Young-Keun Ahn  ;  Han-Young Jin  ;  Dong-Woon Kim  ;  Deok-Kyu Cho  ;  Seung Hyuk Choi  ;  Sang-Hyun Kim  ;  Ki-yuk Chang  ;  Seunghwan Lee  ;  Wookbum Pyun  ;  Nam-ho Lee  ;  Woongchol Kang  ;  Bum-Kee Hong  ;  Byung-Ryul Cho  ;  In-Ho Chae  ;  Joon-Han Shin  ;  Kookjin Chun  ;  Doo-il Kim  ;  Jae-Won Lee  ;  Young-Jae Kim  ;  Donghoon Choi 
Citation
 CLINICAL THERAPEUTICS, Vol.38(3) : 557-573, 2016 
Journal Title
 CLINICAL THERAPEUTICS 
ISSN
 0149-2918 
Issue Date
2016
MeSH
Aged ; Arteries ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Pain/drug therapy ; Pain Measurement ; Peripheral Arterial Disease/drug therapy* ; Succinates/adverse effects ; Succinates/therapeutic use*
Keywords
Anplag Tab ; DP-R202 ; PAD ; sarpogrelate
Abstract
PURPOSE: Sarpogrelate hydrochloride, a selective 5-hydroxytryptamine 2A antagonist, is a widely used antiplatelet agent for the treatment of peripheral arterial disease (PAD). DP-R202 is a new sarpogrelate hydrochloride product with an improved dosage regimen compared with the agent in current use. The aim of this study was to compare the efficacy and safety profile of DP-R202 and Anplag(⁎) Tab in patients with PAD. METHODS: This study was a 12-week, multicenter, randomized, double-blinded, active-controlled, parallel group comparative Phase III clinical trial. One hundred fifty-one volunteer patients with PAD were randomized to receive DP-R202 300 mg once daily or Anplag Table 100 mg TID for 12 weeks. The primary end point was a change in patient assessment of lower leg pain intensity with the use of a visual analog scale (VAS) after 12 weeks of treatment. Results after 4, 8, and 12 weeks of treatment were compared with baseline and between treatment groups, and all patients were assessed for adverse events (AEs), clinical laboratory data, and vital signs. FINDINGS: Two hundred thirty-one patients from 25 medical centers were assessed, and 151 were enrolled and randomly assigned to 1 of 2 treatment groups. Seventy-five patients received DP-R202 300 mg once daily and 76 patients received Anplag Table 100 mg TID for 12 weeks. Analysis of the change in lower leg pain intensity as determined by VAS score between baseline and week 12 (mean [SD], 20.72 [20.06] mm vs 15.55 [21.44] mm) suggested that DP-R202 was not inferior to Anplag Tab, and no significant differences were found in the secondary end points. No significant between-group differences were observed in the prevalence of drug-related clinical- or laboratory-determined AEs. For tolerability, no specific issue was found during the treatment period. IMPLICATION: The results of this study suggest that DP-R202 was not inferior to Anplag Tab for efficacy in patients with PAD and indicated a good safety profile.
Files in This Item:
T201600870.pdf Download
DOI
10.1016/j.clinthera.2016.01.009
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/146550
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