Beneficial Effect of a New Prostacyclin Derivative on the Walking Capacity in Patients with Peripheral Arterial Insufficiency

Abstract

The efficacy, tolerance and safety of iloprost, a stable analogue of car baprostacyclin, were evaluated in 7 patients with peripheral arterial in sufficiency at stage II of Fontaine's classification. After washout, placebo was infused intravenously for seven days, then iloprost was given by a six- hour intravenous infusion of 1 ng/kg/min over the next seven days. At the end of each period, the initial (ICD) and the absolute (ACD) claudi cation distance were measured by distance experienced by such pa tients, an increase in ACD≥50% was considered as clinically relevant. In 3 patients, who experienced such an improvement, iloprost continued to be infused at the same dosage as be fore, for an additional seven days. In the remaining 4 patients (nonrespon ders), the dose was increased to 2 ng/kg/min. At the end of the second week of treatment, all but 1 patient exhibited a > 50% increase in ACD, which was 308±132 meters, a value significantly higher (p < 0.05) than that recorded after the first treat ment period. In contrast, no statisti cal difference was found between the two treatment cycles in regard to ICD and WI. One month after discontinu ation of therapy, ICD was 121±78 meters and ACD 186±110 meters, both values being still significantly higher (p < 0.05) than those recorded on placebo. No significant side effects were observed throughout the study. In conclusion, this study demon strates that iloprost is an effective and well-tolerated means of treating patients suffering from peripheral arterial insufficiency.