[Effectiveness of ciprofibrate. Open study in a Portuguese population].

STUDY OBJECTIVE

To determine the efficacy of ciprofibrate in portuguese patients with hypercholesterolaemia, hypertriglyceridaemia and mixed hyperlipidaemia.

DESIGN

Open-label study with 6-month therapy.

SETTING

Out-patient clinics of two Central Hospitals.

PARTICIPANTS

Sequential sample of 40 patients 20 from each hospital. 37 patients (92.5%) completed the study; 14 had dyslipidaemia type IIa, 12 type IIb and 11 type IV.

METHODS

After at least one month of diet or washout period, all participants were given 100 mg/day of ciprofibrate, taken after the evening meal. Analysis and clinical examinations were performed at weeks (-4), (0), (+8), (+16) and (+24). Total (TC) and HDL (HDL-C) cholesterol, triglycerides (TG), apoproteins A-I, B100, and (a), and fibrinogen were determined. LDL-cholesterol (LDL-C) was calculated by means of the Friedewald formula, whenever TG < or = 400 mg/dl.

MAIN RESULTS

With ciprofibrate, in the whole population, TC, TG, LDL-C, apoB100, and TC/HDL-C ratio diminished, respectively 16.6%, 46.2%, 20.7%, 12.6% and 24.6%. HDL-C and apoA-I increased 10.4% and 4.2%. LDL-C was reduced by 29.5% (p = 0.0001) in type IIa patients, and increased 23% (not statistically significant) in type IV patients. The reduction of TG attained 57.4% in type IIb patients. One type IIb patient received 200 mg/day of the drug from week (+16) on. BMI, waist/hip ratio, hypertension, alcohol consumption and sex didn't affect ciprofibrate activity.

CONCLUSIONS

These results confirm the high efficacy of ciprofibrate in patients with hypercholesterolaemia, hypertriglyceridaemia and mixed hyperlipidaemia. In type IIa dyslipidaemia, the reduction of LDL-C was roughly equivalent to that of the less potent statins. In type IV dyslipidaemia LDL-C may increase moderately. The influence on apoprotein (a) and fibrinogen was positive but modest.