Real World Evidence Study of Statin Use in Brazil

Study Overview
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Brief Summary
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A cross-sectional real-world data study designed to assess the use of statins in individuals assisted within the primary care system in Brazil.

Detailed Description
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Considering the high cardiovascular risk associated to high cholesterol levels, assessing the use of statins in secondary prevention as well as primary prevention individuals in real world settings is key to enable public health policy improvements. The aim of the present study is to assess statins use in primary and secondary prevention individuals assisted by community care workers in the primary care system in Brazil, using a free real world data collection tool (epHealth database). Evaluating factors associated with statins use as well as high dose statins use are also objectives of the study.

Official Title
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Real World Evidence Study for Assessing Statin Use for Primary and Secondary Prevention of Cardiovascular Disease in Primary Care in Brazil

Conditions
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Stroke, Cardiovascular Diseases, Myocardial Infarction, Hypertension, Diabetes Mellitus, Dyslipidemias

Intervention / Treatment
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* Drug: Statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All individuals aged 18 years or older registered on the epHealth database Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Secondary prevention<br>Individuals with previous myocardial infarction and/or stroke | Drug: Statin<br>* Statin use<br>* Other names: rosuvastatin;|
| Primary prevention<br>Individuals with hypertension, diabetes and/or dyslipidemia | Drug: Statin<br>* Statin use<br>* Other names: rosuvastatin;|
| Unknown diagnosis<br>Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia | Drug: Statin<br>* Statin use<br>* Other names: rosuvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin use on secondary prevention | Proportion of patients with previous myocardial infarction and/or stroke on statin use | Baseline | 
| Statin use on primary prevention | Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin use on patients with previous myocardial infarction | Proportion of patients with previous myocardial infarction on statin use | Baseline | 
| Statin use on patients with previous stroke | Proportion of patients with previous stroke on statin use | Baseline | 
| High dose statin use on secondary prevention | Proportion of patients with previous myocardial infarction and/or stroke on high dose statin use | Baseline | 
| High dose statin use on patients with previous myocardial infarction | Proportion of patients with previous myocardial infarction on high dose statin | Baseline | 
| High dose statin use on patients with stroke | Proportion of patients with previous stroke on high dose statin | Baseline | 
| Statin use on patients with diabetes | Proportion of patients with diabetes on statin use | Baseline | 
| Statin use on patients with hypertension | Proportion of patients with hypertension on statin use | Baseline | 
| Statin use on patients with dyslipidemia | Proportion of patients with dyslipidemia on statin use | Baseline | 
| High dose statin use on patients with diabetes | Proportion of patients with diabetes on high dose statin | Baseline | 
| High dose statin use on patients with hypertension | Proportion of patients with hypertension on high dose statin | Baseline | 
| High dose statin use on patients with dyslipidemia | Proportion of patients with dyslipidemia on high dose statin | Baseline | 
| Statin use on patients with unknown diagnosis | Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on statin use | Baseline | 
| High dose statin use on patients with unknown diagnosis | Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on high dose statin use | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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statins, cardiovascular diseases, primary prevention, secondary prevention