Effectiveness and Tolerability of 12-Week Treatment with Micronised Fenofibrate 200mg in a Drug-Monitoring Programme Involving 9884 Patients with Dyslipidaemia
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Following the introduction of micronised fenofibrate (Laboratoires Fournier, Dijon), a new formulation of fenofibrate with an improved pharmacokinetic profile allowing convenient once-daily administration, we performed a drug-monitoring programme in Germany to evaluate the effectiveness and tolerability of 12-week treatment with micronised fenofibrate 200mg in a large sample of patients with various types of dyslipidaemia. In total, 9884 patients were included, and 9503 patients were available for evaluation of effectiveness. In this unselected patient population, micronised fenofibrate 200mg lowered total cholesterol by 20%, low density lipoprotein (LDL) cholesterol by 25%, triglycerides by 28%, and increased high density lipoprotein (HDL) cholesterol by 23%. The LDL/HDL ratio was lowered from a mean of 5.3 to 3.2 after 12 weeks. Effectiveness was further analysed retrospectively in a series of patient populations including different types of dyslipidaemia, type 2 diabetics, and patients with previous myocardial infarction. These analyses were consistent with the results found in the overall population. Treatment with micronised fenofibrate was generally very well tolerated, with 3.8% of patients experiencing adverse events. No adverse reactions were observed that were previously unknown for fenofibrate. The results from this large drug-monitoring programme confirmed the therapeutic interest in micronised fenofibrate in different types of dyslipidaemias and patient populations under the conditions of everyday medical practice.
KeywordsCholesterol Adis International Limited High Density Lipoprotein High Density Lipoprotein Cholesterol Fenofibrate
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- 7.International Task Force for Prevention of Coronary Heart Disease. Prevention of coronary heart disease: scientific background and new clinical guidelines. Nutr Metab Cardiovasc Dis 1992; 2: 113–56Google Scholar
- 8.Food and Drug Administration, Center for Drug Evaluation and research. ‘COSTART’. Coding symbols for thesauraus of adverse reaction terms. 4th ed. Rockvillel993Google Scholar
- 9.Assmann G. Lipid metabolism disorders and coronary heart disease: primary prevention, diagnosis and therapy guidelines for general practice. 2nd rev. ed. Munich: MMV Medizin Verlag, 1993; 33Google Scholar