Plafibride tolerance trial in healthy volunteers.
Tolerance of N-2-(p-chlorophenoxy)-isobutyryl-N'-morpholinomethylurea (plafibride, ITA 104) administered over a 3-month period was studied in a group of healthy volunteers. Acetylsalicylic acid (ASA) was used as a reference drug. Both drugs were administered p.o. at the dose of 1600 mg/d. Plafibride showed a platelet antiaggregant effect similar in intensity to that shown by ASA, but its gastrointestinal tolerance was better. In the same way, plafibride showed a hypolipemic effect which was characterized by a decrease in the plasma level of total lipids and triglycerides and also by a drop in the percentage of the pre-beta-fraction of the lipoproteinogram at the expense of an increase in the alpha-fraction. No rebound effect was noticed when administration of the drug was stopped. The tolerance of plafibride was very good, both from the clinical and analytical point of view.
D000328:Adult; D001241:Aspirin / Q000494:pharmacology*; D002994:Clofibrate / Q000031:analogs & derivatives*; D002995:Clofibric Acid / Q000031:analogs & derivatives* / Q000633:toxicity; D004311:Double-Blind Method; D004906:Erythrocyte Count; D006801:Humans; D000960:Hypolipidemic Agents / Q000633:toxicity; D007958:Leukocyte Count; D008055:Lipids / Q000097:blood; D010974:Platelet Aggregation / Q000187:drug effects
D000960:Hypolipidemic Agents; D008055:Lipids; D002995:Clofibric Acid; C016894:plafibride; D002994:Clofibrate; D001241:Aspirin