Assessment of Health Care Professionals’ Knowledge and Behaviour Regarding Prescribing Conditions of Cholib® (fenofibrate and simvastatin fixed combination): A European PASS conducted in Austria, Portugal, Slovenia, Croatia, Greece and Bulgaria

Study identification

• EU PAS number:
  EUPAS15741
• Study ID:
  34166
• Official title and acronym:
  Assessment of Health Care Professionals’ Knowledge and Behaviour Regarding Prescribing Conditions of Cholib® (fenofibrate and simvastatin fixed combination): A European PASS conducted in Austria, Portugal, Slovenia, Croatia, Greece and Bulgaria
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Croatia

  Portugal

  Slovenia
• Study description:
  Cholib® is a fixed combination tablet, composed of fenofibrate (145 mg) and simvastatin (20 mg or 40 mg) and 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. As a part of the Risk Management Plan (RMP), a drug utilization study (DUS) using available data was planned to estimate the proportion of Cholib® initiators without prior simvastatin monotherapy was not feasible due to inadequate number of patients treated. An alternative approach in the form of a prescriber survey questionnaire in countries where found feasible (Austria, Portugal, Slovenia, Croatia, and Bulgaria) was proposed as per discussion with EMA. The primary objective is to estimate the proportion of first Cholib® prescriptions without prior prescription of simvastatin of the corresponding daily dose (off-label use). The Secondary objectives are to estimate the proportion of first prescriptions of fenofibrate/simvastatin free combination (FSFC) without prior prescription of simvastatin monotherapy of the corresponding daily dose in patients with mixed dyslipidaemia, to describe and categorize the indications for the fenofibrate/simvastatin initiation, differentiating between Cholib® and FSFC to describe demographic and clinical characteristics of patients receiving these drugs.This multi-national, cross-sectional and anonymous web-based survey will be conducted in both public and private settings about physician´s practice and a maximum of 4 recent consecutive anonymous prescriptions of Cholib® and/or FSFC made during the preceding year. Results will be presented, overall and at country level per specialty.
• Study status:
  Planned

Research institutions and networks

Institutions

IMS Health

Study timelines

Date when funding contract was signed

Planned: 31/10/2016

Study start date

Planned: 01/01/2017

Data analysis start date

Planned: 01/03/2017

Date of final study report

Planned: 30/06/2017

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)