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

Abstract

BackgroundThis study evaluated the effects of Beraprost sodium (Berasil) on subjective leg symptoms in patients with peripheral arterial disease caused by diabetes mellitus.MethodsNinety-four diabetic patients with peripheral arterial disease were treated with Beraprost in a fixed-dose, prospective, multicenter, cohort study. Beraprost (40 µg) was administered orally 3 times daily (120 µg/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.ResultsThere 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.ConclusionsBeraprost 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.

Beraprost Sodium for Chronic Diabetic Foot Ulcer: A Randomized Controlled Trial in Thammasat University Hospital

“…Aside from increasing blood flow with anti-platelet aggregation, vasodilatation and endothelial function improvement, 20) BPS improves serum glucose 7) which improves cell function in the healing process and ameliorates diabetic neuropathy. 5,6,21) This results in an increased healing rate as seen in our study.…”

“…8) In the 2013 uncontrolled study, BPS was the effective treatment for improving various subjective symptoms in the lower extremities, such as burning, coldness, edema, exertional pain, stabbing, and paresthesia, in diabetic patients with peripheral arterial disease. 6) In this study, the author designed a randomized controlled trial for studying the result of wound size healing and side-effects using the treatment dose of BPS in chronic diabetic foot ulcer patients that were not in an active ischemic leg. The recommended dose was 120 µg/day, but the study revealed that many patients in the study group had side-effects such as headache.…”

“…3) In diabetes, BPS improved blood circulation 4) and ameliorates diabetic neuropathy in lower extremities. 5,6) In an animal study, BPS improved serum glucose in rats. 7) For these reasons, may BPS ameliorate healing of lower extremities wounds in diabetes?…”

8^th Asian PAD Workshop

“…14) Use of the Endologix AFX unibody stent-graft appears to be a safe and effective endovascular treatment for complex AIOD. 15) EVT for chronic aortoiliac occlusion is associated with a lower perioperative mortality, morbidity and shorter hospital stay. Midlong term patency results are comparable to surgical treatment.…”

“…Beraprost improved various subjective symptoms in the lower extremities such as burning, coldness, edema, exertional pain, stabbing and paresthesias. 15) A meta-analysis of the effect of beraprost on incidence of vascular events in patients with PAD using two studies (BERCI-2 and US trial) demonstrated significant reduction in lower limb vascular disease and all vascular events but not for cardio/cerebrovascular events. 16) Endothelial dysfunction is considered a main pathobiology of atherosclerosis especially in T2DM.…”