J Korean Diabetes Assoc.
2000 Oct;24(5):587-602.
Efficacy and Safety of beraprost sodium in Type 2 Diabetic Subjects Complicated with
Arteriosclerosis Obliterans (ASO): A Prospective, Multicenter, Open Clinical Study
- Affiliations
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- 1Department of Internal Medicine, College of Medicine, Chung-Ang University.
- 2Department of Internal Medicine, College of Medicine,Yonsei University.
- 3Department of Internal Medicine, College of Medicine,Sungkyunkwan University.
- 4Department of Internal Medicine, College of Medicine,Kyung Hee University.
- 5Department of Internal Medicine, College of Medicine,Catholic University.
Abstract
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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.