title: 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.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Division of Cardiology, Department of Internal Medicine, College of Medicine, Pusan National University, Medical Research Institute, Pusan National University Hospital, Pusan, Republic of Korea.
authors: Han Cheol
authors: HC
authors: Lee
authors: Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors: Sang-Rok
authors: SR
authors: Lee
authors: Hallym University, Kangdong Sacred Heart Hospital, Seoul, Republic of Korea.
authors: Kyoo-Rok
authors: KR
authors: Han
authors: Cardiovascular Center (Interventional Cardiology), Anam Hospital, Seoul, Republic of Korea.
authors: Cheol-Woong
authors: CW
authors: Yu
authors: Korea University Guro Hospital, Seoul, Republic of Korea.
authors: Chang-Gyu
authors: CG
authors: Park
authors: Chonnam National University Hospital, GwangJu, Republic of Korea.
authors: Young-Keun
authors: YK
authors: Ahn
authors: Inje University, Busan Paik Hospital, Busan, Republic of Korea.
authors: Han-Young
authors: HY
authors: Jin
authors: Chungbuk National University, Cheongju, Republic of Korea.
authors: Dong-Woon
authors: DW
authors: Kim
authors: Myongji Hospital Cardiovascular Center, Goyang, Republic of Korea.
authors: Deok-Kyu
authors: DK
authors: Cho
authors: Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.
authors: SeungHyuk
authors: S
authors: Choi
authors: Seoul Boramae Hospital, Seoul, Republic of Korea.
authors: Sang-Hyun
authors: SH
authors: Kim
authors: The Catholic University of Korea Seoul St. Mary׳s Hospital, Seoul, Republic of Korea.
authors: Ki-yuk
authors: KY
authors: Chang
authors: Wonju Severance Christian Hospital, Wonju, Republic of Korea.
authors: Seunghwan
authors: S
authors: Lee
authors: Ewha Womans University School of Medicine, Seoul, Republic of Korea.
authors: Wookbum
authors: W
authors: Pyun
authors: Hallym University College of Medicine, Seoul, Republic of Korea.
authors: Nam-Ho
authors: NH
authors: Lee
authors: Gachon University Gil Medical Center, Incheon, Republic of Korea.
authors: Woongchol
authors: W
authors: Kang
authors: Gangnam Severance Hospital, Seoul, Republic of Korea.
authors: Bum-Kee
authors: BK
authors: Hong
authors: Kangwon National University Hospital, ChunCheon, Republic of Korea.
authors: Byung-Ryul
authors: BR
authors: Cho
authors: Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea.
authors: In-Ho
authors: IH
authors: Chae
authors: Ajou University Medical Center, Suwon, Republic of Korea.
authors: Joon-Han
authors: JH
authors: Shin
authors: Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
authors: Kookjin
authors: K
authors: Chun
authors: Inje University Haeundae Paik Hospital, Pusan, Republic of Korea.
authors: Doo-il
authors: DI
authors: Kim
authors: Research and Development division, Alvogen Korea Co., Ltd., Seoul, Republic of Korea.
authors: Jae-Won
authors: JW
authors: Lee
authors: Research and Development division, Alvogen Korea Co., Ltd., Seoul, Republic of Korea.
authors: Young-Jae
authors: YJ
authors: Kim
authors: Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, Republic of Korea. Electronic address: cdhlyj@yuhs.ac.
authors: Donghoon
authors: D
authors: Choi
mesh_terms: D000368:Aged; D001158:Arteries; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D058729:Peripheral Arterial Disease / Q000188:drug therapy*; D013386:Succinates / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D013386:Succinates; C064294:sarpogrelate
keywords: Anplag Tab; DP-R202; PAD; sarpogrelate