Clinical Drug Investigation

, Volume 15, Issue 3, pp 197–204 | Cite as

Effectiveness and Tolerability of 12-Week Treatment with Micronised Fenofibrate 200mg in a Drug-Monitoring Programme Involving 9884 Patients with Dyslipidaemia

  • Klaus U. Kirchgässler
  • Helga Schmitz
  • Günther Bach
Clinical Use

Summary

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.

Keywords

Cholesterol Adis International Limited High Density Lipoprotein High Density Lipoprotein Cholesterol Fenofibrate 

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Copyright information

© Adis International Limited 1998

Authors and Affiliations

  • Klaus U. Kirchgässler
    • 1
  • Helga Schmitz
    • 2
  • Günther Bach
    • 2
  1. 1.Laboratoires Fournier SADaixFrance
  2. 2.Fournier Pharma GmbHSulzbachGermany

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