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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
Impact Factor 0,899
Online ISSN 1827-1839
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.