EFFECT OF CIPROFIBRATE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA - A 6-YEAR PILOT-STUDY

The efficacy and tolerability of a single daily dose of ciprofibrate, a fibrate derivative with a prolonged half-life, were evaluated in an open-label study with 6 years of follow-up. The study included 26 pati ents (12 men, 14 women; mean age, 56 years) with primary type IIa (n = 19) or type IIb (n = 7) hypercholesterolemia. Patients received 100 m g/d ciprofibrate for up to 6 years (mean, 36 months). Comparing baseli ne and final values (means of the last three assessments) in each pati ent, independent from length of treatment, total and low-density lipop rotein and cholesterol decreased from 312 +/- 40 mg/dL to 250 +/- 42 m g/dL (-20%) (P less than or equal to 0.001) and from 210 +/- 37 mg/dL to 172 +/- 40 mg/dL (-18%) (P less than or equal to 0.001), respective ly. Ciprofibrate reduced serum triglyceride levels from 202 +/- 152 mg /dL to 116 +/- 52 mg/dL (-43%) (P less than or equal to 0.0001) and in creased high-density lipoprotein cholesterol levels from 49 +/- 10 mg/ dL to 53 +/- 11 mg/dL (+8%) (P less than or equal to 0.01). Hematochem ical safety parameters were monitored during the whole study. Alkaline phosphatase significantly (P less than or equal to 0.01) decreased af ter 3 months (from 77 +/- 22 U/L to 55 +/- 15 U/L) and remained consta nt thereafter. No significant changes were noted in serum transaminase s and creatine kinase levels. The frequency of clinical adverse events was negligible, and compliance with therapy was good, In conclusion, 100 mg/d of ciprofibrate, administered for 6 years to patients with pr imary isolated or mixed hypercholesterolemia, was effective and well t olerated. Further controlled studies in larger groups of patients are needed to fully confirm these promising results.