Abstract
Prostaglandin E1 (PGE1) and one of its prodrugs, AS-013, were formulated in lipid microspheres (lipo-PGE1 and lipo-AS, respectively), and their acute clinical efficacy and safety were compared in a randomized, placebo-controlled, single-blind test. Lipo-PGE1 (10 μg), lipo-AS (5 μg), or an inactive placebo was intravenously administered to human subjects once daily for 3 days. The acute efficacy of lipo-PGE1 and lipo-AS was each quantitatively assessed in male patients with chronic peripheral arterial occlusive diseases (PAOD) by measuring ankle brachial pressure, skin temperature, transcutaneous oxygen pressure (tcPO2), transcutaneous carbonic dioxide pressure, and cutaneous blood flow (BF) with a laser Doppler flowmeter during and after administration of each drug. Informed consent was obtained from all patients. Laboratory data did not suggest any adverse effect of lipo-AS administration, which significantly improved tcPO2 and BF, suggesting that the microhemorrheological effects of lipo-AS are of potential therapeutic value in the treatment of PAOD.
