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
First published:
01/02/2024
Institution

Contact details

Toussi Massoud

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
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)