title: Comparison of beraprost and ticlopidine in Chinese patients with chronic peripheral arterial occlusion: a multicenter, single-blind, randomized, controlled study.
abstract: BACKGROUND
  Chronic peripheral arterial occlusion (CPAO) is a progressive disease that is associated with a variety of symptoms, the 4 most common being a sensation of coolness in the limbs, intermittent claudication (in which pain occurs on walking), limb pain (which occurs spontaneously at rest), and ischemic leg ulcers. Beraprost sodium is an oral prostaglandin I2 analogue that may ameliorate these symptoms.
  
  
  OBJECTIVE
  The aim of this study was to compare the efficacy and tolerability of beraprost sodium and ticlopidine hydrochloride in the treatment of patients with CPAO in China.
  
  
  METHODS
  In this multicenter, single-blind, controlled study, patients with CPAO were randomly assigned to receive beraprost 120-μg tablet TID or ticlopidine 500-mg tablet BID, both administered orally. The clinical efficacy of the drugs was assessed using the 4 main symptoms of CPAO. Ankle-brachial index (ABI) also was measured as a clinical pharmacologic procedure. Adverse events were assessed throughout the study.
  
  
  RESULTS
  A total of 124 patients (96 men, 28 women; mean [SD] age, 65 [12] years) were enrolled in 3 hospitals. Data from 119 patients (93 men, 26 women; mean [SD] age, 65 [12] years) were included in the efficacy analysis (64 and 55 patients in the beraprost and ticlopidine groups, respectively). Although all 4 symptoms of CPAO were ameliorated after 3 and 6 weeks of treatment with both drugs, only the cool sensation was significantly improved with beraprost compared with ticlopidine at 6 weeks (P<0.05). ABI was significantly increased with both beraprost and ticlopidine at 6 weeks versus baseline (P<0.001 and P<0.01, respectively), suggesting that this pharmacologic action may have led to their beneficial effect on various symptoms. The tolerability analysis included 123 patients (65 and 58 patients in the beraprost and ticlopidine groups, respectively). The numbers of patients who (1) experienced adverse events (AEs), (2) experienced adverse drug reactions, and (3) withdrew due to AEs were significantly smaller in the beraprost group than in the ticlopidine group (P<0.001, P<0.05, and P<0.05, respectively).
  
  
  CONCLUSIONS
  In this study population of patients with CPAO, beraprost ameliorated cool sensation in the limbs, intermittent claudication, limb pain, and ischemic/leg ulcers. Beraprost was more efficacious in relieving CPAO symptoms and was better tolerated than ticlopidine. Beraprost may be useful for the treatment of patients with CPAO, but more studies are needed.
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Heng
authors.initials: H
authors.lastname: Guan
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Yuqi
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China.
authors.forename: Baigen
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Ye
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Weiguo
authors.initials: W
authors.lastname: Fu
authors.affiliation: Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Liang
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Changwei
authors.initials: C
authors.lastname: Liu
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Jue
authors.initials: J
authors.lastname: Yang
authors.affiliation: Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China.
authors.forename: Jiwei
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Yongjun
authors.initials: Y
authors.lastname: Li
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Daqiao
authors.initials: D
authors.lastname: Guo
authors.affiliation: Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Yuehong
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Jianrong
authors.initials: J
authors.lastname: Ye
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Xiaozhong
authors.initials: X
authors.lastname: Huang
authors.affiliation: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Bao
authors.initials: B
authors.lastname: Liu
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Chen
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Junhao
authors.initials: J
authors.lastname: Jiang
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Longhua
authors.initials: L
authors.lastname: Fan
authors.affiliation: Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China.
authors.forename: Zhenyu
authors.initials: Z
authors.lastname: Shi
authors.affiliation: Asian Business Department, Yamanouchi Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Yamamoto
keywords: Beraprost; peripheral arterial occlusion; prostaglandin I2 analogue; ticlopidine