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

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 ShinKookjin Chun, Doo Il Kim, Jae Won Lee, Young Jae Kim, Donghoon Choi

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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.

Original languageEnglish
Pages (from-to)557-573
Number of pages17
JournalClinical Therapeutics
Volume38
Issue number3
DOIs
Publication statusPublished - 2016 Mar 1

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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    Lee, H. C., Lee, S. R., Han, K. R., Yu, C. W., Park, C. G., Ahn, Y. K., Jin, H. Y., Kim, D. W., Cho, D. K., Choi, S. H., Kim, S. H., Chang, K. Y., Lee, S., Pyun, W., Lee, N. H., Kang, W., Hong, B. K., Cho, B. R., Chae, I. H., ... Choi, D. (2016). 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. Clinical Therapeutics, 38(3), 557-573. https://doi.org/10.1016/j.clinthera.2016.01.009