A PRELIMINARY DOUBLE-BLIND CROSS-OVER TRIAL OF LIPO-PGI2, A PROSTACYCLIN DERIVATIVE INCORPORATED IN LIPID MICROSPHERES, IN CEREBRAL INFARCTION

Lipo-PGI2 is a drug preparation of a PGI2 analogue (isocarbacyclin methylester) which is incorporated into lipid microspheres with a diameter of 0.2μ. lipo-PGI2 has been shown to accumulate at the vascular wall, particularly those of arteriosclerotic lesions, and it has a much stronger inhibitory activity on platelet aggregation than free isocarbacyclin. In this study, a preliminary double-blind cross over trial of lipo-PGI2 in cerebral infarction was carried out. Seventeen patients with chronic cerebral infraction received 2μg of lipo-PGI2 and placebo daily for one week each in a cross-over double blind test. A significant improvement was noted for lipo-PGI2 compared with placebo in the overall improvement in neurological and mental symptoms (p<0.01). The patient's preference also indicated the effectiveness of lipo-PGI2 (p<0.05). Adverse reactions were noted in 3 patients receiving placebo, but not in any receiving lipo-PGI2. These results show that lipo-PGI2 at a very low dose would be beneficial as a treatment for relieving the clinical symptoms of chronic cerebral infarction and that lipid microspheres are a useful drug carrier for PGI2 analogue therapy. © 1990.