Background. It is difficult to achieve satisfactory decreases of both plasma LDL-cholesterol (LDL-C) and
triglycerides (TG) and increase of HDL-C with only single statin or fibrate treatment of patients with mixed
hyperlipoproteinaemias (HLP). Combination treatment with both statin and fibrate has been shown to enhance
achieving of recommended targets in these patients with high-risk of coronary heart disease. On the other hand
unpleasant side effects including myopathy and rhabdomyolysis were described in some cases after statin-fibrate
combination therapy. Aim of the study was to evaluate efficacy and safety of long-term treatment of pravastatin+fenofibrate
or simvastatin+ciprofibrate therapy in the high-risk group of patients with severe mixed hyperlipoproteinemia.
Methods and Results. A set of 86 patients (55 M/31 F) was followed for a period at least one year (median 3 years).
These patients were randomly assigned to combination of pravastatin 20 mg + fenofibrate 200mg (n=46) (group A),
or simvastatin 20 mg + ciprofibrate 100 mg (n=40) (group B). We have observed significant reduction in plasma TC
(22 % in group A, 20 % in group B), in LDL-C (36 %, resp. 33 %), reduction of TG (44 %, resp. 46 %), apo-B (35 %,
resp. 33 %) whilst HDL-C significantly increased (18 %, resp. 16 %). Concomitantly we have seen significant
decreases in uricaemia (14 %, resp. 18 %). No patient needed to stop treatment due to abnormalities in liver function
tests. Levels of creatinkinase became non-significantly elevated (by 16%, resp. 13%).No patient exhibitedmyopathy
Conclusions. The long-term combined therapy with statin-fibrate (pravastatin 20 mg + fenofibrate 200 mg, or
simvastatin 20 mg + ciprofibrate 100 mg) in severe mixed HLP was safe and effectively improved plasma lipid and
apolipoprotein levels. Both combinations seemed to be similarly efficient and safe.
combination hypolipidemic therapy, statins, fibrates, mixed hyperlipoproteinemia.