Oral Beraprost Sodium as a Prostaglandin I2 Analogue for Vascular Events in Patients with Peripheral Arterial Disease : Meta-Analysis of Two Placebo-Controlled Randomized Trials
10.3820/jjpe1996.9.45
- Author:
Hideki ORIGASA
;
Yasuo IKEDA
;
Kazuyuki SHIMADA
;
Hiroshi SHIGEMATSU
- Publication Type:Journal Article
- Keywords:
prostacyclin;
beraprost sodium;
meta-analysis;
intermittent claudication;
vascular event
- From:Japanese Journal of Pharmacoepidemiology
2004;9(2):45-51
- CountryJapan
- Language:English
-
Abstract:
Objective : To evaluate the effect of beraprost sodium (beraprost) on the vascular events occurring in patients with peripheral arterial disease (PAD) in a meta-analysis of placebo-controlled, randomized trials.
Design : Meta-analysis
Methods : Among the clinical trials of beraprost in patients with intermittent claudication associated with PAD, placebo-controlled, randomized trials with vascular events as outcome measures were selected. Two trials met the criteria, each of which was a comparative trial of beraprost (40 μg t.i.d.) and placebo (t.i.d.), with a six-month follow-up period.
Results : With both trials combined, the analysis included 594 patients in the beraprost group and 590 in the placebo group. The risk ratio was 0.608 (95%CI : 0.41 to 0.90, p =0.012), demonstrating the efficacy of beraprost on all vascular events. The risk ratio for lower limb deterioration was 0.598 (95% CI : 0.34 to 1.06, p =0.079), which was similar to that for all vascular events. A statistically insignificant but similar result was also obtained for cardio/cerebrovascular events with a risk ratio of 0.619 (95%CI : 0.36 to 1.07, p = 0.085). Heterogeneity between the two studies was not found for any of the events.
Conclusion : The results demonstrated the efficacy of beraprost on the vascular events in patients with PAD. The potential benefit of beraprost on vascular events will require evaluation in a larger prospective investigation.
