Koing Bo Kwun

Open-label, uncontrolled, 6-week clinical trial of beraprost in patients with chronic occlusive arterial disease

Abstract The efficacy and tolerability of beraprost sodium, sodium (±)-(1 R ,2 R ,3a S ,8b S )-2,3,3a,8b-tetrahydro-2-hydroxy-1-[(E)-(3 S ,4 RS )-3-hydroxy-4-methyl-1-octen-6-ynyl]-1H cyclopenta[ b ]benzofuran-5 butyrate, a prostacyclin analogue, were investigated in 23 patients (21 men and 2 women; mean age, 49.6 ± 15.4 years; mean body weight, 59.9 ± 8.0 kg) with chronic occlusive arterial disease and its complications, arteriosclerosis obliterans, and thromboangiitis obliterans with ischemic limb ulceration. In this open-label, uncontrolled study, beraprost was administered orally at a daily dosage of 40 μg (two 20-μg tablets) TID for 6 weeks. The subjective symptoms of rest pain and coldness of limbs improved in 14 patients (60.9%), and ischemic ulcer size and the appearance of granulation improved in 16 (69.6%) and 19 patients (82.6%), respectively. Ulcer size (calculated as the square root of the longest diameter × shortest diameter) at baseline (8.8 mm) had decreased significantly after 6 weeks of treatment (5.0 mm). One drug-related adverse event and several abnormal laboratory values were noted; however, all were mild and transient. These observations suggest that beraprost may be useful in treating chronic occlusive arterial diseases, and they support the need for controlled clinical studies of efficacy and tolerability in men and women.