Status: Finalised First registered on: 06/06/2013
Last updated on: 06/06/2013
1. Study identification
EU PAS Register NumberEUPAS4085
Official titleCost-Effectiveness Analysis of Treatment with Statins in Primary Prevention of Vascular Events.
Study title acronymEPREV project
Study typeObservational study
Brief description of the studyObjectives: 1. To Analyze the cost-effectiveness of statins treatment by different baseline cardiovascular risk strata. 2. To analyze the cost-effectiveness of statins therapy according to baseline cholesterol and total cholesterol reduction. 3. Set breakpoints based on the baseline cardiovascular risk, cholesterol and basal absolute reduction of cholesterol on the basis of the cost-effectiveness. Subjects: People without a history of vascular events receiving treatment in any public Primary Care Centre (Institut Català de la Salut). Data will be obtained from the Information System for the Development of Primary Care Research (SIDIAP) whose primary source of data are electronic medical records (e-CAP) and other data sources, such as CATSALUT's invoice offices pharmacy and the Minimum Basic Data Set (CMBD). Methodology: The design consists of two parts: firstly, from a matched cohort on the basis of propensity score, we will estimate the following parameters : 1. incidence density of cardio and cerebrovascular events, 2. population risk factors prevalence for baseline cardiovascular risk calculations, 3. Markov model utilities. The study will include approximately 83,500 new users of statins in the period of the study and a ratio of at least 3 controls per case (250,000 persons in the unexposed group). The follow-up period will be four years. Subsequently, we will build a Markov model for cost-utility analysis from cohort data and data on costs from the perspective of the NHS. The analysis will be performed based on the ratio of incremental cost-effectiveness (ICER).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research group
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Ms
Last name Garcia
First name Maria
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201001/01/2010
Start date of data collection01/04/201001/12/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201303/04/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyHealth Ministry100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Garcia
First name Maria
Address line 1Maluquer Salvador 11
Address line 2 
Address line 3 
CityGirona 
Postcode 
CountrySpain
Phone number (incl. country code)34972487968 
Alternative phone number 
Fax number (incl. country code) 
Email address mgarcia@idiapjgol.info
Public Enquiries
Title Ms 
Last name Garcia 
First name Maria 
Address line 1Maluquer Salvador 11 
Address line 2 
Address line 3 
CityGirona 
Postcode 
CountrySpain 
Phone number (incl. country code)34972487968 
Alternative phone number 
Fax number (incl. country code) 
Email address mgarcia@idiapjgol.info 
Top