A randomized, double-blind, crossover comparison of iloprost with dextran in patients with peripheral arterial occlusive disease.

Iloprost, a stable carbaprostacyclin analog, was infused (up to 2-4 ng/kg/min) for 12 h daily on 5 consecutive days into the forearm vein of 13 patients with peripheral arterial occlusive disease (PAOD) of legs (stages IIb-III). All vasodilatory and antiplatelet drugs were stopped three weeks earlier. For comparison, dextran was infused in a randomized, crossover, double-blind manner with an average interval of 3 months. Iloprost increased significantly ankle systolic pressure and ankle/arm pressure ratio for the follow-up period of one month. Foot skin temperature increased insignificantly. Pain-free walking distance was prolonged up to 1.51 times by iloprost and 1.14 times by dextran (p less than 0.05). Venous occlusion plethysmography showed no improvement in the blood flow of legs. Eight patients experienced a subjective improvement in their clinical status with iloprost. Ten patients suffered from mild to severe headache, nausea, transient rest pain of legs, and hypotension. One patient with gastric ulcer history was withdrawn because of mild hematemesis, not definitely drug-related. No significant changes occurred in standard laboratory safety control or in hemostasis. The results suggest that a 5-day iloprost infusion exerts a mild favourable effect on patients with PAOD.