Cost-Effectiveness Analysis of Treatment with Statins in Primary Prevention of Vascular Events (EPREV project)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/4086
• EU PAS number:
  EUPAS4085
• Study ID:
  4086
• Official title and acronym:
  Cost-Effectiveness Analysis of Treatment with Statins in Primary Prevention of Vascular Events (EPREV project)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Objectives: 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).
• Study status:
  Finalised

Research institution and networks

Institutions

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Contact details

Maria Garcia

Study contact

[e-mail]

Maria Garcia

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 01/01/2010

Actual: 01/01/2010

Data collection

Planned: 01/04/2010

Actual: 01/12/2010

Date of final study report

Planned: 31/12/2013

Actual: 03/04/2013

Sources of funding

Other

More details on funding

Health Ministry

Regulatory

• Was the study required by a regulatory body?:
  No