Clin Orthop Surg.  2013 Jun;5(2):145-151. 10.4055/cios.2013.5.2.145.

Effects of Beraprost Sodium on Subjective Symptoms in Diabetic Patients with Peripheral Arterial Disease

• Yoon HS
• Choi WJ
• Sung IH
• Lee HS
• Chung HJ
• Lee JW

• KMID: 1705537
• DOI: http://doi.org/10.4055/cios.2013.5.2.145

Abstract

BACKGROUND
This study evaluated the effects of Beraprost sodium (Berasil) on subjective leg symptoms in patients with peripheral arterial disease caused by diabetes mellitus.
METHODS
Ninety-four diabetic patients with peripheral arterial disease were treated with Beraprost in a fixed-dose, prospective, multicenter, cohort study. Beraprost (40 microg) was administered orally 3 times daily (120 microg/day) for 12 weeks. We developed a new disease-specific symptom questionnaire, which evaluated the effect of peripheral arterial disease on leg discomfort in daily life and assessed therapeutic responses to treatment. Patients were asked for their subjective assessment of symptoms on a written questionnaire before treatment and after 12 weeks of therapy.
RESULTS
There was significant improvement in all estimated subjective symptoms (burning, coldness, edema, exertional pain, stabbing, and paresthesias) in the lower extremities at 12 weeks (p < 0.001). There were 18 patients with neuropathy in whom significant improvement was noted for 6 subjective symptoms at 12 weeks (p < 0.05). Adverse events considered to be drug-related were observed in 4 patients (4.3%), all of which were mild and resolved with discontinuation of the medication.
CONCLUSIONS
Beraprost is effective as a treatment for improving various subjective symptoms in the lower extremities, such as burning, coldness, edema, exertional pain, stabbing, and paresthesias, in diabetic patients with peripheral arterial disease.

Keyword

Peripheral arterial disease; Intermittent claudication; Diabetes mellitus; Beraprost sodium; Prostaglandin I2

MeSH Terms

Adult
Aged
Aged, 80 and over
Cohort Studies
Diabetes Complications/*drug therapy/physiopathology
Epoprostenol/*analogs & derivatives/therapeutic use
Female
Humans
Male
Middle Aged
Peripheral Arterial Disease/complications/*drug therapy
Platelet Aggregation Inhibitors/*therapeutic use
Prospective Studies
Statistics, Nonparametric
Epoprostenol
Platelet Aggregation Inhibitors