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.