title: A pilot study of ranolazine in patients with intermittent claudication.
abstract: OBJECTIVE
  This pilot study provides preliminary information regarding safety and changes in exercise performance during treatment with ranolazine extended-release in patients with reproducible claudication during exercise treadmill testing (ETT).
  
  
  METHODS
  We enrolled 45 patients with documented peripheral arterial disease, reproducible claudication on ETT, and ankle-brachial indices <0.85 at rest that decreased by at least 0.15% or 20% immediately postexercise. Randomized patients received double-blind treatment with either ranolazine 1 000 mg b.i.d. (n=22) or placebo (n=23) for 4 weeks.
  
  
  RESULTS
  Compared with baseline, peak walking time (PWT) increased (mean+/-SEM) by 53+/-34 s with ranolazine (P=0.13) and by 41+/-33 s with placebo (P=0.22). Pain-free walking time during ETT increased by 62+/-18 s with ranolazine (P=0.002) and 36+/-18 s with placebo (P=0.045). Supplemental analyses, excluding patients with baseline exercise duration (16 min and (12 min, showed additional improvement with ranolazine on PWT.
  
  
  CONCLUSIONS
  Ranolazine was well tolerated and these data provide a rationale for proceeding with a definitive trial.
authors.affiliation: Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: A
authors.initials: A
authors.lastname: Ma
authors.forename: W T
authors.initials: WT
authors.lastname: Garland
authors.forename: W B
authors.initials: WB
authors.lastname: Smith
authors.forename: S
authors.initials: S
authors.lastname: Skettino
authors.forename: M T
authors.initials: MT
authors.lastname: Navarro
authors.forename: A Q
authors.initials: AQ
authors.lastname: Chan
authors.forename: B E
authors.initials: BE
authors.lastname: Anderson
authors.forename: J P
authors.initials: JP
authors.lastname: Cooke
mesh_terms: D000083:Acetanilides / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010879:Piperazines / Q000627:therapeutic use*; D000069458:Ranolazine
chemical_list: D000083:Acetanilides; D010879:Piperazines; D000069458:Ranolazine