A pilot study of ranolazine in patients with intermittent claudication.
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.
Ma
A
A
Stanford University School of Medicine, Stanford, CA, USA.
Garland
W T
WT
Smith
W B
WB
Skettino
S
S
Navarro
M T
MT
Chan
A Q
AQ
Anderson
B E
BE
Cooke
J P
JP
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
D000083:Acetanilides; D010879:Piperazines; D000069458:Ranolazine