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.
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 200 mg (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 exhibited myopathy or rhabdomyolysis.
The long-term combined therapy with statin-fibrate (pravastatin 20 mg + fenofirbrate 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.