Clinical studyA comparison of cilostazol and pentoxifylline for treating intermittent claudication☆
Section snippets
Material and methods
Design of this trial followed the recommendations of the Society for Vascular Surgery for trials of medications treating intermittent claudication (7). The study was conducted under an Investigational New Drug Exemption with approval of each of the 54 participating institutions’ human subjects review committees and the written informed consent of each participant.
Patients with stable, moderate-to-severe symptoms of intermittent claudication were studied. Symptoms must have been present for at
Results
We screened 922 consenting patients, of whom 699 (76%) met the inclusion criteria and were randomly assigned to one of the three treatments (Figure 1). One patient withdrew before taking the first drug dose, leaving 698 patients who could be evaluated. There were no statistically significant differences in the baseline characteristics of the three groups (Table 1). Of the 698 patients who started treatment, 159 (23%) withdrew from the study before the last visit (week 24). Withdrawal rates
Discussion
Standard medical management of patients with intermittent claudication from atherosclerotic peripheral artery disease includes a walking exercise program, smoking cessation, antiplatelet therapy, treatment of atherosclerosis risk factors, evaluation for associated cardiovascular disease (such as coronary artery disease), and, in some patients, drug treatment for symptomatic relief. Surgical or endovascular intervention is usually reserved for patients with severe, lifestyle-limiting symptoms
Acknowledgements
The following institutions and persons contributed to the Claudication Treatment Study. Wilford Hall Medical Center: DL Dawson; University of Massachusetts Medical Center: BS Cutler; Jobst Vascular Center: HG Beebe; Baylor College of Medicine: JA Herd; Chicago Center for Clinical Research: M Davidson; Jacksonville Cardiovascular Clinic: DA Chinoy; Ochsner Clinic: SR Money; University of Colorado Health Sciences Center: JG Regensteiner; Definitive Health: T Bajwa; University of Virginia: DW
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Supported by Otsuka America Pharmaceuticals, Inc., a US affiliate of the manufacturer of cilostazol. The views expressed herein are those of the authors and do not reflect the official policy of the Department of Defense, the Department of Veterans Affairs, or other departments of the United States government.