OBJECTIVES: In the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of @entity63 events in @entity1 with @entity613 . BACKGROUND: Previous trials with beraprost @entity1372 , an orally active @entity4770 analogue, in the treatment of @entity613 in @entity1 with @entity3657 ( @entity3657 ) have been inconsistent. METHODS: @entity1 with @entity613 (n = 897) were randomized to receive either 40 microg 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 @entity158 -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 @entity158 -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 @entity65 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 @entity65 and @entity583 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 @entity613 in @entity1 with @entity3657 . The potential benefit of beraprost on critical @entity65 would require confirmation in a larger prospective investigation.

Treatment of @entity613 with beraprost @entity1372 , an orally active XXXX analogue: a double-blinded, randomized, controlled trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity3657 :: ('MESH:D058729', 'Disease') :: ['PAD', 'peripheral arterial disease'] @entity63 :: ('MESH:D007511', 'Disease') :: ['ischemic'] @entity1372 :: ('MESH:D012964', 'Chemical') :: ['sodium'] @entity4770 :: ('MESH:D011464', 'Chemical') :: ['prostaglandin I(2)'] @entity613 :: ('MESH:D007383', 'Disease') :: ['claudication', 'intermittent claudication'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity583 :: ('MESH:D009203', 'Disease') :: ['myocardial infarction'] @entity65 :: ('MESH:D002318', 'Disease') :: ['cardiovascular events', 'cardiovascular death']
@entity4770 :: (MESH:D011464,Chemical) :: ['prostaglandin I2']
