Abstract
ObjectiveThe purpose of this study was to assess the efficacy of administering iloprost therapy via a flow-regulator system compared with the traditional peristaltic pump infusion system. BackgroundIloprost is a potent prostacyclin (PGI2) analogue that is effective in the treatment of thromboangiitis obliterans, peripheral arterial occlusive disease, scleroderma, Raynaud's phenomenon, and primary pulmonary hypertension. Due to its rapid clearance from the central compartment, iloprost is usually administered intravenously with a peristaltic pump infusion system, which limits its use to hospitalized patients. MethodsIn this open-label, randomized clinical trial, we used a simple plastic tube with a flow regulator (calibrated in milliliters per minute), instead of a peristaltic pump, to administer iloprost 0.5 to 2.0 ng/kg per minute. ResultsBetween January 1995 and December 1999, 82 patients were enrolled in the study. They received iloprost by infusion for a combined total of 4056 days. Iloprost was well tolerated; no patient withdrew from the study as a result of adverse events. Preliminary results showed that the flow-regulator system had clinical effects comparable to those obtained with the peristaltic pump infusion system. ConclusionsUse of a flow regulator could provide advantages in administering PGI2 analogue therapy for various ischemic diseases.
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