A Stable Prostacyclin Analogue (Iloprost) in the Treatment of Buerger's Disease: A Prospective Analysis of 150 Patients

Purpose: To assess the efficacy and of iloprost in the treatment of Buerger's disease. Methods: In this prospective study, 158 patients with rest pain and/or ischemic ulcers from 17 clinics were administered 1 ng/kg/min intravenous iloprost for 28-days. The primary endpoint was complete healing without pain or major amputation at 24 weeks. The secondary endpoints were pain assessment, reduction in ulcer area, 50% reduction of the ulcer size, shift in the modified SVS/ISCVS clinical status grading scale, global assessment by the investigator and an independent observer at 4 and 24 weeks. The comparisons were carried out with the initial values. The final evaluation was carried out in 150 patients. Results: Complete healing rate was significantly better with iloprost treatment in comparison to the initial values at 24 weeks (