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[Efficacy and safety of combined statin-fenofibrates therapy compared with monotherapy in patients with mixed hyperlipidemia and high risk of coronary heart disease].

UNLABELLED
In most patients with mixed hyperlipidemia and coronary heart disease (CHD) the treatment targeted both at triglyceride and LDL cholesterol levels is very difficult, when one lipid-lowering drug is used. We performed a prospective study evaluating the efficacy and safety of statins (simvastatin 20 mg, fluvastatin 40 mg, lovastatin 20 mg, atorvastatin 10 mg) and fibrates (fenofibrate 200 mg, ciprofibrate 100 mg) used alone, and then compared with statin-fibrate combinations in 180 patients. Each of three periods of therapy lasted 8-12 weeks. All regimens of statins and fibrates normalised the lipid profile more effectively than monotherapy. Monotherapy with statins lowered total cholesterol by 23.8% in relation to the baseline; compared with 13% for fibrates monotherapy and 34.3% for statins plus fibrates combinations. Triglyceride concentration decreased by 25.5% with statins alone, 34.0% with fibrates alone and 44.5% with combined therapy. LDL cholesterol was reduced by 28.1%, 12.7%, 40.3%, respectively. Statins increased HDL cholesterol by 4%, fibrates by 18% and combined therapy by 15.2%. The target levels for LDL cholesterol were achieved in 3.7% patients on statins therapy, in 1.1% on fibrates and 21.7% on the combined therapy. For total cholesterol the changes were 8.3%, 2.2% and 41.7%, respectively and for triglycerides the were 27.7%, 45% and 66.7%, respectively. The safety of the treatment was assessed by recording adverse events and measuring clinical laboratory parameters. No significant increase in CPK or ALT levels was observed. Only 7 patients had a history of moderate ALT increase (< 3 times) and 27 of CPK increase (< 3 times) when receiving combined statins plus fibrates.


CONCLUSIONS
We conclude that combined therapy with statins and fibrates can improve lipid abnormalities in mixed hyperlipidaemia more effective then statins or fibrates monotherapy. The combined therapy was well tolerated and safe.