Effects of beraprost sodium in the treatment of diabetic peripheral artery disease

Abstract

Objective To evaluate the efficacy of beraprost sodium in the treatment of diabetic peripheral artery disease. Methods Thirty diabetic patients with peripheral artery disease treated from November 2009 to August 2010 were randomized into two groups in the ratio of 2 to 1: the group A treated with beraprost sodium(40 μg tid, n=20) and the group B with aspirin (100 mg qd, n=10)for 12 weeks. The pain-free walking distance (PFWD), maximum walking distance (MWD) were measured at 0 week (before treatment), 12 week (after treatment) and 24 week (12 weeks follow-up after treatment). Ankle-brachial index (ABI) and metabolic data were evaluated at 0 and 12 week. The t, χ2 and rank test was used in the data analysis. Results No differences in age, gender and diabetic complications was found between two groups. Ischemic symptoms were significantly improved in group A than in group B (90.0% vs 50.0%, χ2=5.96, P 0.05)and 1075 meters(Z=-2.54, P 0.05) at 12 weeks, 24 weeks respectively in group B. No significant differences in the PFWD was found at baseline, 12 weeks and 24 weeks between two groups. But the absolute increased PFWD was 125 meters for group A and 30 meters for group B at 12 weeks(Z=-2.87, P<0.05); 82.5 and 0 meters at 24 weeks in group A and group B(Z=-3.31, P<0.05). The absolute increased MWD was 500, 50 meters (Z=-3.20, P<0.05) and 300, 10 meters (Z=-3.02, P<0.05) at 24 weeks in the group A and B, respectively. No significant side reaction of the beraprost treatment in these two groups. Conclusion Beraprost can be used effectively and safely in the treatment of diabetic artery disease. Key words: Diabetes mellitus, type 2; Peripheral vascular diseases; Beraprost sodium