Drug utilisation study (DUS) on the use of Cholib® (fenofibrate and simvastatin fixed combination): a European multinational study using secondary health records databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15808
• EU PAS number:
  EUPAS9827
• Study ID:
  15808
• Official title and acronym:
  Drug utilisation study (DUS) on the use of Cholib® (fenofibrate and simvastatin fixed combination): a European multinational study using secondary health records databases
• DARWIN EU® study:
  No
• Study countries:
  France

  Hungary
• Study description:
  Statins have been shown to reduce total cholesterol and LDL-C levels. They are commonly used and recommended in patients with dyslipidaemia (Catapano et al. 2011).3 Fibrates are also used to lower total cholesterol and triglycerides (TG) levels. They are prescribed to patients intolerant to statins alone, or as second line of treatment in combination with statins.Combination of simvastatin and fenofibrate leads to additional improvement of lipid parameters compared with simvastatin monotherapy in patients with mixed dyslipidaemia who required a treatment targeting a broader lipoprotein spectrum (Grundy et al. 2005).11Cholib® is a fixed combination tablet, composed of fenofibrate (145 mg) and simvastatin (20mg or 40mg). It will be the first available registered drug combining both substances in one tablet.Cholib® is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL- C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.Initiation of Cholib® treatment requires an adequate pre-treatement with simvastatin (at 20 or 40 mg) otherwise it is considered off-label use. This potential risk is part of the Risk Management Plan (RMP) and will be further investigated in this study conducted to estimate the proportion of patients who initiated Cholib® without prior simvastatin therapy.
• Study status:
  Planned

Research institutions and networks

Institutions

IMS Health

Study timelines

Date when funding contract was signed

Planned: 06/01/2015

Actual: 06/01/2015

Study start date

Planned: 01/06/2015

Date of final study report

Planned: 31/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mylan

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)