Results of a phase IV study carried out with acipimox in type II diabetic patients with concomitant hyperlipoproteinaemia.

The aim of this phase IV study was to assess the tolerability and efficacy of acipimox, a lipid-lowering drug, in 3009 type II diabetic out-patients with types II and IV hyperlipoproteinaemia. The study was carried out by 150 Italian diabetes centres. Acipimox was given at the dosage of one capsule (250 mg), two or three times daily for at least 2 months. Acipimox produced a mean fall of 43% in serum triglycerides and of 18% in total serum cholesterol levels compared with baseline. The lipid-lowering effect was present throughout treatment, but was most pronounced at the end of treatment. An increase in the serum concentration of high density lipoprotein cholesterol (15%) was also observed at the end of the trial. Fasting blood glucose and glycosylated haemoglobin levels showed a slight reduction during the study. Adverse events were reported in 263 (8.8%) cases and 165 (5.4%) patients discontinued the treatment. The female trial population showed a nearly two-fold greater incidence of adverse events than the males. In the majority of cases the adverse events experienced by patients were transient episodes of flushing and mild gastro-intestinal disturbances (e.g. gastric pain and pyrexia).