beraprost and Peripheral-Arterial-Disease

The effect of the prostaglandin I2 analog, beraprost sodium (BPS), on hemodialysis (HD) patients with peripheral arterial disease (PAD) has not been fully elucidated. The effect of BPS was compared to that of PAD drugs in HD patients with PAD in a multicenter randomized prospective interventional pilot study (J-PADD). Seventy-two PAD patients on HD were entered and randomly divided into two groups; that is, BPS group (Group A: n = 35) and PAD drug (cilostazol or sarpogrelate) group (Group B: n = 37). Primary endpoint was changes in skin perfusion pressure (SPP). Kidney Disease Quality of Life (KDQOL) score, cardiovascular events, PAD events, and adverse events were also evaluated. SPP increased significantly in both groups at 24 weeks from their basal levels. The absolute increase of SPP in Group A and Group B were 15.4 ± 30.0 mm Hg (P < 0.0001) and 20.2 ± 22.1 mm Hg (P = 0.025) (instep), and 13.8 ± 19.3 mm Hg (P < 0.0001) and 9.2 ± 16.3 mm Hg (P = 0.041) (sole), respectively. Changes of KDQOL score showed significantly better result in the role of physical score in Group A compared with Group B. Although heart rate was unchanged in Group A, 9.3/min increase was seen in Group B patients who received cilostazol. There was no intergroup difference in cardiovascular events and/or PAD events between the two groups during the study period. This exploratory pilot study suggested BPS was as effective as anti-platelet drugs in improving microcirculation in HD patients.

Topics: Aged; Aged, 80 and over; Cilostazol; Epoprostenol; Female; Heart Rate; Humans; Male; Microcirculation; Middle Aged; Peripheral Arterial Disease; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Quality of Life; Renal Dialysis; Succinates; Tetrazoles; Treatment Outcome

This study evaluated the effects of Beraprost sodium (Berasil) on subjective leg symptoms in patients with peripheral arterial disease caused by diabetes mellitus.. Ninety-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.. 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.. 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.

Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Diabetes Complications; Epoprostenol; Female; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Prospective Studies; Statistics, Nonparametric

Beraprost sodium (BPS) is a stable, orally active prostaglandin I(2) (PGI(2) ) analog with antiplatelet and vasodilating properties. It has been reported that PGI(2) has pleiotropic effects that are anti-inflammatory and anti-atherogenic. In this study, we aim to determine the relationship between PGI(2) and renal anemia. We conducted a prospective randomized trial including 20 hemodialysis patients. Ten patients were assigned to be treated with 120 µg/day of BPS and the other patients were assigned to a control group. After six months, the titer of hemoglobin had significantly increased in the BPS group compared to the baseline (11.1 ± 0.3 g/dL vs. 10.3 ± 1.4 g/dL, respectively), and there was a significant difference between the BPS group and the control group. The level of ferritin was lower in the BPS group compared to the control group, but the average dose of erythropoietin did not significantly change. These findings suggest that BPS may improve renal anemia in hemodialysis patients.

Topics: Administration, Oral; Aged; Aged, 80 and over; Anemia; Epoprostenol; Erythropoietin; Female; Ferritins; Hemoglobins; Humans; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Renal Dialysis; Vasodilator Agents