Measurement of the effectiveness of statins in vascular morbidity and mortality reduction in the population without history of vascular disease but with intermediate risk and ankle-brachial Index < 0.9 in primary care setting (MARIA study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/4089
• EU PAS number:
  EUPAS4088
• Study ID:
  4089
• Official title and acronym:
  Measurement of the effectiveness of statins in vascular morbidity and mortality reduction in the population without history of vascular disease but with intermediate risk and ankle-brachial Index < 0.9 in primary care setting (MARIA study)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Objective: To evaluate the effectiveness of statin therapy to reduce the incidence of vascular disease in patients with unknown history of vascular disease with intermediate cardiovascular risk (5-15% at 10 years) and abnormal ankle-brachial index (<0.9). Design: Population matched cohort on the basis of propensity score. Data were obtained from the Information System for the Development of Primary Care Research whose primary source of data is the the electronic health records (e-CAP) of the Institut Català de la Salut. Subjects: Population from 35 to 74 years without known vascular disease and with intermediate cardiovascular risk and ankle-brachial index <0.9 (3684 subjects in exposed cohort and 7368 in unexposed cohort). The recruitment period will be guarantee at least 3 years of follow-up. Variables: New statin users are defined according to the criteria of compliance (> 80%) and persistence (> 6 months) and with no invoicing data in the six months before the entry of the cohort. Outcomes: incidence of major cardiovascular events defined as cerebrovascular disease (fatal or not), myocardial infarction (fatal or not), unstable angina, revascularization, intermittent claudication, peripheral arterial disease diagnosis or gangrene and amputation. Moreover, death from any cause will be registered. Independent variables: demographic variables, presence of risk factors, other comorbidities, complementary tests and other drug treatments. Statistical analysis: Time varying Cox regression models will be performed to estimate the incidence of outcomes of interest adjusted for the variable start of treatment and dose (time-dependent variables) and other variables associated with the occurrence of vascular events. We will also calculate estimates of risk reduction and the number needed to treat.
• Study status:
  Finalised

Research institutions and networks

Institutions

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

Spain

Study timelines

Date when funding contract was signed

Planned: 01/01/2010

Actual: 01/01/2010

Study start date

Planned: 01/04/2010

Actual: 01/12/2010

Date of final study report

Planned: 31/12/2013

Actual: 05/05/2013

Sources of funding

Other

More details on funding

Health Ministry

Regulatory

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