PMID- 24944399 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140619 LR - 20211021 IS - 0011-393X (Print) IS - 0011-393X (Linking) VI - 64 IP - 7 DP - 2003 Jul TI - Comparison of beraprost and ticlopidine in Chinese patients with chronic peripheral arterial occlusion: a multicenter, single-blind, randomized, controlled study. PG - 488-503 LID - 10.1016/S0011-393X(03)00125-5 [doi] AB - 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-mug 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. FAU - Guan, Heng AU - Guan H AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Wang, Yuqi AU - Wang Y AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Zhang, Baigen AU - Zhang B AD - Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China. FAU - Ye, Wei AU - Ye W AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Fu, Weiguo AU - Fu W AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Liang, Wei AU - Liang W AD - Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China. FAU - Liu, Changwei AU - Liu C AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Yang, Jue AU - Yang J AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Zhang, Jiwei AU - Zhang J AD - Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China. FAU - Li, Yongjun AU - Li Y AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Guo, Daqiao AU - Guo D AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Zhang, Hao AU - Zhang H AD - Ren Ji Hospital, Shanghai Second Medical University, Shanghai, China. FAU - Zheng, Yuehong AU - Zheng Y AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Ye, Jianrong AU - Ye J AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Huang, Xiaozhong AU - Huang X AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Liu, Bao AU - Liu B AD - Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China. FAU - Chen, Bin AU - Chen B AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Jiang, Junhao AU - Jiang J AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Fan, Longhua AU - Fan L AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Shi, Zhenyu AU - Shi Z AD - Zhong Shan Hospital, Medical Center of Fudan University, Shanghai, China. FAU - Yamamoto, Minoru AU - Yamamoto M AD - Asian Business Department, Yamanouchi Pharmaceutical Co., Ltd., Tokyo, Japan. LA - eng PT - Journal Article PL - United States TA - Curr Ther Res Clin Exp JT - Current therapeutic research, clinical and experimental JID - 0372621 PMC - PMC4053019 OTO - NOTNLM OT - Beraprost OT - peripheral arterial occlusion OT - prostaglandin I2 analogue OT - ticlopidine EDAT- 2003/07/01 00:00 MHDA- 2003/07/01 00:01 PMCR- 2003/07/01 CRDT- 2014/06/20 06:00 PHST- 2003/05/20 00:00 [accepted] PHST- 2014/06/20 06:00 [entrez] PHST- 2003/07/01 00:00 [pubmed] PHST- 2003/07/01 00:01 [medline] PHST- 2003/07/01 00:00 [pmc-release] AID - S0011-393X(03)00125-5 [pii] AID - 10.1016/S0011-393X(03)00125-5 [doi] PST - ppublish SO - Curr Ther Res Clin Exp. 2003 Jul;64(7):488-503. doi: 10.1016/S0011-393X(03)00125-5.