Diabetes & Metabolism Journal

Original Article

Efficacy and Safety of beraprost sodium in Type 2 Diabetic Subjects Complicated with Arteriosclerosis Obliterans (ASO): A Prospective, Multicenter, Open Clinical Study.: Yeon Sahng Oh, Young Deuk Song, Moon Kyu Lee, Young Seol Kim, Ho Young Son; Korean Diabetes J. 2000;24(5):587-602. Published online January 1, 2001

Abstract: BACKGROUND
Beraprost sodium (BPS) is a new stable, orally active prostaglandin I2 analogue with antiplatelet and vasodilating properties. We performed an prospective, multicenter, open clinical trial to assess the efficacy and safety of BPS in type 2 diabetic patients complicated with arteriosclerosis obliterans (ASO). METHOD: We recruited 34 type 2 diabetic patients complicated with ASO at 5 different university hospitals. Patients received BPS 40 g tid for 6-week. Patients performed a subjective and objective assessment of treatment usefulness at 2- and 6-week. Safety was assessed by obtaining clinical data and history. RESULTS: There was a significant difference between before and after treatment for changes regarding the items "chillness", "numbness" and "rest pain". An improve ment in intermittent claudication distance at the 2-or 4-week interval was achieved. Ankle Pressure Index (API) was not statistically different. The side effects including fever, myalgia, indigestion were subtle and the patients' compliance is good. CONCLUSION: These results show that BSP is an effective and safe symptomatic treatment of Type 2 diabetic patients with ASO.

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