Author + information
- Received October 18, 2002
- Revision received December 16, 2002
- Accepted December 18, 2002
- Published online May 21, 2003.
- 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∥
- ↵*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.
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 I2analogue, 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.
☆ This study was financed by the United Therapeutics Corporation.
A list of the investigators and Critical Cardiovascular Events Committee is available on-line
- Received October 18, 2002.
- Revision received December 16, 2002.
- Accepted December 18, 2002.
- American College of Cardiology Foundation