Progress in the prostaglandin E1-therapy of the intermittent claudication by means of bolus injections of LIPO-prostaglandin E1 (LIPO-PGE1)

Abstract

Objective:

We compared the efficacy of a bolus injection (5 min) of LIPO-PGE₁ (Prostaglandin E₁ in lipid emulsion) with conventional PGE₁-cyclodextrin (PGE₁-cyclodextrin) infusions (2 h) in patients with intermittent claudication. The quantitative blood-flow in the common femoral artery was measured using a computerized ultrasound Doppler system (MAVIS^®). we also monitored the transcutaneous oxygen pressure, the skin temperature on the foot, and the reactive change in blood pressure and pulse as well as side effects.

Results

: Dose finding of LIPO-PGE₁: After bolus injection of 30, 50, and 80 μg LIPO-PGE₁ a significant dose-dependent increase of the blood flow in the leg (+ 96.9%, 80 μg) with a peak 3 h after injection was seen. After LIPO-PGE₁ we observed an enhanced microcirculation (significant rise in the transcutaneous oxygen pressure and the skin temperature on the foot). We noted longer lasting pharmacodynamic properties with LIPO-PGE₁ (50 μg) compared to PGE₁-cyclodextrin (60 μg). Comparison to PGE₁-cyclodextrin: In a cross-over, placebo-controlled study, 20 patients with intermittent claudication received 4 weeks therapy with a bolus of 50 μg LIPO-PGE₁ or a 2 h infusion of 60 μg PGE₁-cyclodextrin per day. A significant increase in the blood flow was measured at the end of 4 weeks therapy compared to the initial values before treatment. This rise correlates significantly with the increase in the patient’s maximal walking distance (+112%, LIPO-PGE₁). Compared to conventional PGE₁-cyclodextrin infusions given over 2 h, a clearly prolonged increase in perfusion of the affected limb after LIPO-PGE₁ was demonstrated. No serious adverse effects were observed.