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Rivista di Angiologia
Official Journal of the , the International Union of Phlebology and the
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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International Angiology 2006 December;25(4):361-9
A pilot study of ranolazine in patients with intermittent claudication
Ma A. 1, Garland W. T. 2, Smith W. B. 3, Skettino S. 4, Navarro M. T. 4, Chan A. Q. 1, Anderson B. E. 5, Cooke J. P. 1
1 Stanford University School of Medicine, Stanford, CA, USA
2 Radiant Research, San Diego, CA, USA
3 New Orleans Center for Clinical Research, New Orleans, LA, USA
4 Roche Palo Alto, Palo Alto, CA, USA
5 Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA
Aim. 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.