Double-blind study on the activity of plafibride in the treatment of type IV hyperlipoproteinemia.

The effects of a new drug, N-2-(p-chlorophenoxy)-isobutyryl-N'-morpholinomethylurea (plafibride, ITA 104), were studied in a double blind study lasting four months on a group of 30 patients with a type IV hyperlipoproteinemia. In the patients treated with the active drug significant reductions in blood triglycerides were obtained, with a trend to normal. Reduction in blood cholesterol was inconsistent and not significant. As for the lipoproteinogram, a tendency towards a decrease in the pre-beta-lipoprotein fraction was observed and so was a non-significant tendency towards an increase in the alpha- and beta-lipoprotein fractions. Studies on the platelet functioning showed an obvious decrease in platelet aggregation in those patients treated with the active drug. This was very evident for the ADP and adrenaline inductors and rather less significant for collagen. Neither platelet adhesiveness nor aggregation rate changed. Tolerance of the drug was generally excellent. In one patient a decrease in some palpebral xanthelasmas was observed after two months of treatment with the active drug. In only one case there was heartburn and this was corrected with alkalines. In one other case an urticarial rash appeared, but disappeared spontaneously when the drug was temporarily stopped and did not reappear when it was administered again. During the trial no evidence of renal, hepatic or hematological malfunctions were observed. However, a slight tendency towards an increase in the GOT, GPT and LDH was observed, which was not statistically significant. The drug tested may be very useful in the treatment of type IV hyperlipoproteinemia, especially in those forms in which an increase in thromboembolic risk is suspected, either associated with, or secondary to, the actual atherosclerotic disease.