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CLINICAL RESEARCH

Treatment of intermittent claudication with beraprost sodium, an orally active prostaglandin I₂ analogue

A double-blinded, randomized, controlled trial

Emile R. Mohler, III, MD, FACC^*,*, William R. Hiatt, MD, Jeffrey W. Olin, DO, FACC, Michael Wade, PhD, Roger Jeffs, PhD and Alan T. Hirsch, MD, FACC^||

^* University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
University of Colorado Health Sciences Center and Colorado Prevention Center, Denver, Colorado, USA
Mount Sinai School of Medicine, New York, New York, USA
United Therapeutics, Research Triangle Park, North Carolina, USA
^|| University of Minnesota Medical School, Minneapolis, Minnesota, USA

Manuscript received October 18, 2002; revised manuscript received December 16, 2002, accepted December 18, 2002.

^* Reprint requests and correspondence: Dr. Emile R. Mohler III, University of Pennsylvania School of Medicine, Room 432, Philadelphia Heart Institute, 51 North 39th Street, Philadelphia, Pennsylvania 19104, USA.
mohlere{at}uphs.upenn.edu

OBJECTIVES: In the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of ischemic events in patients with intermittent claudication.

BACKGROUND: Previous trials with beraprost sodium, an orally active prostaglandin I₂ analogue, in the treatment of claudication in patients with peripheral arterial disease (PAD) have been inconsistent.

METHODS: Patients with intermittent claudication (n = 897) were randomized to receive either 40 µg three times a day of beraprost with meals (n = 385) or placebo (n = 377) in a double-blinded manner for one year. The primary efficacy parameter was treadmill-measured maximum walking distance, as assessed at three and six months after randomization. Secondary efficacy parameters included treadmill-measured pain-free walking distance and change in quality of life.

RESULTS: There was no significant improvement in maximum walking distance in the beraprost group (16.7%) as compared with the placebo group (14.6%, p = NS). Administration of beraprost did not improve the pain-free walking distance (p = NS between treatment groups), and there was no improvement in the quality-of-life measures between the treatment groups. The incidence of critical cardiovascular events was 7.3% in the beraprost group and 11.4% in the placebo group (p = NS). There was a significant reduction in the combination of cardiovascular death and myocardial infarction in the beraprost group (p = 0.01).

CONCLUSIONS: Despite previous investigations suggesting efficacy, these results indicate that beraprost is not an effective treatment to improve symptoms of intermittent claudication in patients with PAD. The potential benefit of beraprost on critical cardiovascular events would require confirmation in a larger prospective investigation.

Abbreviations and Acronyms   ABI   ankle-brachial index   BERCI-2   Beraprost et Claudication Intermittente study   MWD   maximum walking distance   PAD   peripheral arterial disease   PFWD   pain-free walking distance   PGI2   prostaglandin I2   QOL   quality of life   SF-36   short-form 36   TID   three times a day   WIQ   walking impairment questionnaire

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