PMID- 26856926
OWN - NLM
STAT- MEDLINE
DCOM- 20161031
LR  - 20181202
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 38
IP  - 3
DP  - 2016 Mar
TI  - 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.
PG  - 557-73
LID - S0149-2918(16)00022-9 [pii]
LID - 10.1016/j.clinthera.2016.01.009 [doi]
AB  - 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.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Lee, Han Cheol
AU  - Lee HC
AD  - Division of Cardiology, Department of Internal Medicine, College of Medicine, 
      Pusan National University, Medical Research Institute, Pusan National University 
      Hospital, Pusan, Republic of Korea.
FAU - Lee, Sang-Rok
AU  - Lee SR
AD  - Chonbuk National University Hospital, Jeonju, Republic of Korea.
FAU - Han, Kyoo-Rok
AU  - Han KR
AD  - Hallym University, Kangdong Sacred Heart Hospital, Seoul, Republic of Korea.
FAU - Yu, Cheol-Woong
AU  - Yu CW
AD  - Cardiovascular Center (Interventional Cardiology), Anam Hospital, Seoul, Republic 
      of Korea.
FAU - Park, Chang-Gyu
AU  - Park CG
AD  - Korea University Guro Hospital, Seoul, Republic of Korea.
FAU - Ahn, Young-Keun
AU  - Ahn YK
AD  - Chonnam National University Hospital, GwangJu, Republic of Korea.
FAU - Jin, Han-Young
AU  - Jin HY
AD  - Inje University, Busan Paik Hospital, Busan, Republic of Korea.
FAU - Kim, Dong-Woon
AU  - Kim DW
AD  - Chungbuk National University, Cheongju, Republic of Korea.
FAU - Cho, Deok-Kyu
AU  - Cho DK
AD  - Myongji Hospital Cardiovascular Center, Goyang, Republic of Korea.
FAU - Choi, SeungHyuk
AU  - Choi S
AD  - Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.
FAU - Kim, Sang-Hyun
AU  - Kim SH
AD  - Seoul Boramae Hospital, Seoul, Republic of Korea.
FAU - Chang, Ki-yuk
AU  - Chang KY
AD  - The Catholic University of Korea Seoul St. Mary׳s Hospital, Seoul, Republic of 
      Korea.
FAU - Lee, Seunghwan
AU  - Lee S
AD  - Wonju Severance Christian Hospital, Wonju, Republic of Korea.
FAU - Pyun, Wookbum
AU  - Pyun W
AD  - Ewha Womans University School of Medicine, Seoul, Republic of Korea.
FAU - Lee, Nam-Ho
AU  - Lee NH
AD  - Hallym University College of Medicine, Seoul, Republic of Korea.
FAU - Kang, Woongchol
AU  - Kang W
AD  - Gachon University Gil Medical Center, Incheon, Republic of Korea.
FAU - Hong, Bum-Kee
AU  - Hong BK
AD  - Gangnam Severance Hospital, Seoul, Republic of Korea.
FAU - Cho, Byung-Ryul
AU  - Cho BR
AD  - Kangwon National University Hospital, ChunCheon, Republic of Korea.
FAU - Chae, In-Ho
AU  - Chae IH
AD  - Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea.
FAU - Shin, Joon-Han
AU  - Shin JH
AD  - Ajou University Medical Center, Suwon, Republic of Korea.
FAU - Chun, Kookjin
AU  - Chun K
AD  - Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
FAU - Kim, Doo-il
AU  - Kim DI
AD  - Inje University Haeundae Paik Hospital, Pusan, Republic of Korea.
FAU - Lee, Jae-Won
AU  - Lee JW
AD  - Research and Development division, Alvogen Korea Co., Ltd., Seoul, Republic of 
      Korea.
FAU - Kim, Young-Jae
AU  - Kim YJ
AD  - Research and Development division, Alvogen Korea Co., Ltd., Seoul, Republic of 
      Korea.
FAU - Choi, Donghoon
AU  - Choi D
AD  - Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, 
      Republic of Korea. Electronic address: cdhlyj@yuhs.ac.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160205
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Succinates)
RN  - 19P708E787 (sarpogrelate)
SB  - IM
MH  - Aged
MH  - Arteries
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/drug therapy
MH  - Pain Measurement
MH  - Peripheral Arterial Disease/*drug therapy
MH  - Succinates/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Anplag Tab
OT  - DP-R202
OT  - PAD
OT  - sarpogrelate
EDAT- 2016/02/10 06:00
MHDA- 2016/11/01 06:00
CRDT- 2016/02/10 06:00
PHST- 2015/03/19 00:00 [received]
PHST- 2016/01/08 00:00 [revised]
PHST- 2016/01/09 00:00 [accepted]
PHST- 2016/02/10 06:00 [entrez]
PHST- 2016/02/10 06:00 [pubmed]
PHST- 2016/11/01 06:00 [medline]
AID - S0149-2918(16)00022-9 [pii]
AID - 10.1016/j.clinthera.2016.01.009 [doi]
PST - ppublish
SO  - Clin Ther. 2016 Mar;38(3):557-73. doi: 10.1016/j.clinthera.2016.01.009. Epub 2016 
      Feb 5.