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.
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