Clinical Efficacy of Intra-Arterial PGE₁-Infusion in Intermittent Claudication: A Double-Blind Study

Summary

As part of a double-blind study we investigated 50 patients (26 male and 24 female patients between 44 and 86 years of age). These patients were given one 100 ml intra-arterial infusion of 10–20 µg PGE₁ over a period of 90 min (3–5 ng/kg · min) or a placebo infusion daily (except for Saturdays and Sundays) for 3 weeks.

All the patients were in stable stage IIb of peripheral occlusive arterial disease and presented with vascular occlusion in the thigh and/or lower leg confirmed by angiography.

The main criterion of efficacy in this clinical study was the exercise tolerance of the patients; there was a significant improvement in their pain-free (P = 0.0029) and maximum (P = 0.00029) walking distance under PGE₁ treatment (their pain-free walking distance increased by 109%) as opposed to a minimal increase in walking distance of 35% in the placebo group.

Two weeks after the end of treatment the walking distance had increased by a further 50% (P = 0.00034) in the PGE₁ group, whereas in the control group the walking distance was 10% shorter 2 weeks after the end of treatment. Despite the advanced arteriosclerosis, apart from plasma viscosity, which was minimally pathological, the haemorheological parameters (haematocrit, erythrocyte aggregation, erythrocyte deformability) were on average normal even at the start of the study. There were no significant changes during the treatment, either in the PGE₁ group or in the placebo group.

Doppler ultrasonography, venous occlusion plethysmography and laboratory tests were done before the start of treatment, 1 week later and after the end of treatment. None of these tests revealed any significant changes during or after the treatment.