Abstract 5065: Outpatient Treatment of Severe Intermittent Claudication with Intravenous Pge1: The Oracle Study. Efficacy and Costs. Improvement in Cardiovascular Morbidity/Mortality
Efficacy and costs of prostaglandin E1 (PGE1) treatment in severe intermittent claudication (walking distance <50 m), in subjects with concomitant severe coronary disease, was studied using in a 30-week study. These end-stage patients had previously been treated with state-of-the-art treatments and were severely handicapped. Phase 1 was a two-week run-in phase (no treatment). In phase 2, treatment was performed in two days with 30 – 60min infusions (PGE1, at the dose of 1 microgram per Kg of weight, once daily, in 50 ml of saline). The cycle was repeated every week for 20 weeks. During the follow up (Phase 3,10 weeks), no PGE1 was used. A treadmill test was performed at inclusion, at 10. 20 and 30 weeks. A progressive training plan and reduction in risk factors was used in PGE1 patients and in comparable controls following the same management program without PGE1. Subjects received the ‘best treatment’ and a supervised, personalised exercise program. Out of the 255 patients in the two groups 236 completed the study (102: PGE1 group; 134: control group). The groups were comparable in age/sex distribution, total walking distance (TWD: 45;sd12m vs 43;8m) and risk factors. At 20 weeks, the increase in TWD was up to 155;13m in the PGE1 vs 78;18m in controls (p<0.021). At 30 weeks it was 198;21m in the PGE1 groups vs 72.3;12m (p<0.022). PGE1 treatment was well tolerated. Costs of PGE1 protocol were limited (13% of the program) producing an effects 2.75 times greater (p<0.05) than the control program. Cardiovascular morbidity and mortality - (comparison with historical, comparable groups) decreased in both groups. There were no cardiovascular events (deaths, strokes or myocardial infactions) in the PGE1 group; there were 5 events (including two deaths) in controls (p<0.0013).
CONCLUSIONS. The study (ORACLE), in progress, favours PGE1 treatment considering TWD and the effects on cardiovascular mortality/morbidity. PGE1 has positive effects both on peripheral vascular disease and on the myocardial and brain circulation.