title: Propionyl-L-carnitine improves exercise performance and functional status in patients with claudication.
abstract: OBJECTIVE
  We tested the hypothesis that propionyl-L-carnitine would improve peak walking time in patients with claudication. Secondary aims of the study were to evaluate the effects of propionyl-L-carnitine on claudication onset time, functional status, and safety.
  
  
  METHODS
  In this double-blind, randomized, placebo-controlled trial, 155 patients with disabling claudication from the United States (n = 72) or Russia (n = 83) received either placebo or propionyl-L-carnitine (2g/day orally) for 6 months. Subjects were evaluated at baseline and 3 and 6 months after randomization with a graded treadmill protocol at a constant speed of 2 miles per hour, beginning at 0% grade, with increments in the grade of 2% every 2 minutes until maximal symptoms of claudication forced cessation of exercise. Questionnaires were used to determine changes in functional status.
  
  
  RESULTS
  At baseline, peak walking time was 331 +/- 171 seconds in the placebo group and 331 +/- 187 seconds in the propionyl-L-carnitine group. After 6 months of treatment, subjects randomly assigned to propionyl-L-carnitine increased their peak walking time by 162 +/- 222 seconds (a 54% increase) as compared with an improvement of 75 +/- 191 seconds (a 25% increase) for those on placebo (P <0.001). Similar improvements were observed for claudication onset time. Propionyl-L-carnitine treatment significantly improved walking distance and walking speed (by the Walking Impairment Questionnaire), and enhanced physical role functioning, reduced bodily pain, and resulted in a better health transition score (by the Medical Outcome Study SF-36 Questionnaire). The incidence of adverse events and study discontinuations were similar in the two treatment groups.
  
  
  CONCLUSIONS
  Propionyl-L-carnitine safely improved treadmill exercise performance and enhanced functional status in patients with claudication.
authors.affiliation: Department of Medicine, Section of Vascular Medicine, Divisions of Geriatrics and Cardiology, University of Colorado Health Sciences Center, Denver 80203, USA.
authors.forename: W R
authors.initials: WR
authors.lastname: Hiatt
authors.forename: J G
authors.initials: JG
authors.lastname: Regensteiner
authors.forename: M A
authors.initials: MA
authors.lastname: Creager
authors.forename: A T
authors.initials: AT
authors.lastname: Hirsch
authors.forename: J P
authors.initials: JP
authors.lastname: Cooke
authors.forename: J W
authors.initials: JW
authors.lastname: Olin
authors.forename: G N
authors.initials: GN
authors.lastname: Gorbunov
authors.forename: J
authors.initials: J
authors.lastname: Isner
authors.forename: Y V
authors.initials: YV
authors.lastname: Lukjanov
authors.forename: M S
authors.initials: MS
authors.lastname: Tsitsiashvili
authors.forename: T F
authors.initials: TF
authors.lastname: Zabelskaya
authors.forename: A
authors.initials: A
authors.lastname: Amato
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology*; D002331:Carnitine / Q000031:analogs & derivatives* / Q000494:pharmacology*; D004311:Double-Blind Method; D017079:Exercise Tolerance / Q000187:drug effects*; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C003223:propionylcarnitine; D002331:Carnitine