Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Acute myocardial infarction
Ischaemic stroke
Coronary revascularisation
Peripheral revascularisation
Population studied

Short description of the study population

People without a history of vascular events receiving treatment in any public Primary Care Centre (Institut Català de la Salut)

Age groups

  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)

Estimated number of subjects

100000
Study design details

Main study objective

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

Outcomes

Acute myocardial infarction, ischemic stroke, coronary revacularization procedures, cardiovascular and global mortality, Statin adverse effects

Data analysis plan

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).