58 Cilostazol or Pentoxifylline for Claudication?
David L. Dawson, Wilford Hall Med Ctr, Lackland AFB, AK; Hugh G. Beebe, Jobst Vascular Ctr, Toledo, OH; Michael H. Davidson, Chicago Ctr for Clin Res, Chicago, IL; David A. Chinoy, Jacksonville CV Ctr, Jacksonville, FL; J Alan Herd, Baylor Coll of Medicine, Houston, TX; William R. Hiatt, Univ of Colorado, Denver, CO; Jeffrey D. Heckman, Enoch B. Bortey, William P. Forbes, Otsuka America Pharm, Inc., Rockville, MD
Background: Pentoxifylline (PTX) is the only FDA approved drug for treating claudication symptoms in patients with peripheral arterial disease (PAD), but a series of US trials has demonstrated efficacy of a new drug, cilostazol (CLZ). The present study compared these two drugs. Methods: A 24 week, multicenter, randomized, double-blind, placebo and active-controlled parallel group study was conducted to assess the relative efficacy and safety of CLZ 100 mg bid, PTX 400 mg tid, and placebo (PLC) for the treatment of claudication secondary to PAD. Results: Fifty-four centers enrolled 698 patients with stable claudication. Efficacy was evaluated using a constant speed, variable-grade treadmill protocol at baseline and every 4 weeks. Compared to PLC, CLZ significantly increased Maximum Walking Distance (MWD) and Pain Free Walking Distance (PFD), but PTX did not. There were 6 deaths in the study (CLZ=2, PTX=3, PLC=1). Serious adverse events were equal in each treatment group (CLZ 11.9%, PTX 13.4%, PLC 13.0%). The most common non-serious adverse events were headache (CLZ 27.8%, PTX 11.2%, PLC 11.7%), abnormal stools (CLZ 14.5%, PTX 5.2%, PLC 2.9%), and palpitations (CLZ 17.2%, PTX 2.2%, PLC 1.3%). Conclusion: CLZ is an effective and well-tolerated alternative for treating symptoms of claudication. PTX did not significantly improve treadmill-measured walking distance, compared to PLC.
[Corrections for Circulation. 1998;98[suppl I]:I–112. Abstract 58.]
- Copyright © 1999 by American Heart Association