title: A study on the efficacy and safety assessment of propionyl-L-carnitine tablets in treatment of intermittent claudication.
abstract: OBJECTIVE
  This study investigated the efficacy, safety and tolerability of propionyl-L-carnitine (PLC) in patients with intermittent claudication in the Chinese population.
  
  
  METHODS
  In this randomized, multicentre, phase III, double-blind, parallel-group study, 239 patients were randomized to receive PLC 2g ⁄ day orally or placebo for 4 months (120 vs.119). The primary efficacy endpoint was the improvement of peak walking time (PWT) after treatment over baseline, and the secondary endpoints were the improvement of claudication onset time (CT) and ankle/brachial index (ABI).
  
  
  RESULTS
  In the Per Protocol Set (PPS), PWT of the intervention group increased 1.6±1.6 minutes after treatment (p<0.05). With PLC treatment, CT was significantly decreased in the treatment group. ABI was increased in both treatment and control groups. However, no statistical significance was found. In the Safety Analysis Set (SS), there were 110 adverse events during the course of the study (67 in PLC group vs. 43 in control group). There were two serious adverse events in the PLC group and four in the placebo group. All of the SAEs were assessed as unrelated to the study drug which indicated that PLC was well-tolerated in PAD patients.
  
  
  CONCLUSIONS
  The study showed PLC significantly prolonged the maximum walking time and walking distance of Chinese patients with peripheral arterial disease with well-tolerated performance.
authors.affiliation: Xuanwu Hospital Capital Medical University, No. 45, Changchun Street, Xuanwu District, Beijing, China, 100053. Electronic address: doctorluo@yahoo.cn.
authors.forename: Tao
authors.initials: T
authors.lastname: Luo
authors.forename: Jianxin
authors.initials: J
authors.lastname: Li
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Baozhong
authors.initials: B
authors.lastname: Yang
authors.forename: Changjian
authors.initials: C
authors.lastname: Liu
authors.forename: Qi
authors.initials: Q
authors.lastname: Zheng
authors.forename: Bi
authors.initials: B
authors.lastname: Jin
authors.forename: Zhong
authors.initials: Z
authors.lastname: Chen
authors.forename: Ke
authors.initials: K
authors.lastname: Li
authors.forename: Xiwei
authors.initials: X
authors.lastname: Zhang
authors.forename: Jian
authors.initials: J
authors.lastname: Zhang
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002331:Carnitine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000503:physiopathology; D008875:Middle Aged; D010431:Pentoxifylline / Q000627:therapeutic use; D058729:Peripheral Arterial Disease / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D016138:Walking
chemical_list: C003223:propionylcarnitine; D002331:Carnitine; D010431:Pentoxifylline
keywords: Propionyl-L-carnitine; clinical trial; intermittent claudication; peripheral arterial disease; thrombosis