Real World Evidence Study of Statin Use in Brazil

Completed

• Conditions: Stroke; Diabetes Mellitus; Hypertension; Myocardial Infarction; Cardiovascular Diseases; Dyslipidemias
• Interventions: Drug: Statin

• Registration Number: NCT05285085
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-11-19
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2022-03
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-17
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2133900

Inclusion Criteria

• All individuals aged 18 years or older registered on the epHealth database

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unknown diagnosis	Statin	Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia
Primary prevention	Statin	Individuals with hypertension, diabetes and/or dyslipidemia
Secondary prevention	Statin	Individuals with previous myocardial infarction and/or stroke

Primary Outcome Measures

Name	Time	Method
Statin use on primary prevention	Baseline	Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use
Statin use on secondary prevention	Baseline	Proportion of patients with previous myocardial infarction and/or stroke on statin use

Secondary Outcome Measures

Name	Time	Method
High dose statin use on patients with hypertension	Baseline	Proportion of patients with hypertension on high dose statin
Statin use on patients with hypertension	Baseline	Proportion of patients with hypertension on statin use
Statin use on patients with dyslipidemia	Baseline	Proportion of patients with dyslipidemia on statin use
High dose statin use on patients with dyslipidemia	Baseline	Proportion of patients with dyslipidemia on high dose statin
Statin use on patients with unknown diagnosis	Baseline	Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on statin use
Statin use on patients with previous myocardial infarction	Baseline	Proportion of patients with previous myocardial infarction on statin use
Statin use on patients with diabetes	Baseline	Proportion of patients with diabetes on statin use
High dose statin use on secondary prevention	Baseline	Proportion of patients with previous myocardial infarction and/or stroke on high dose statin use
High dose statin use on patients with previous myocardial infarction	Baseline	Proportion of patients with previous myocardial infarction on high dose statin
High dose statin use on patients with stroke	Baseline	Proportion of patients with previous stroke on high dose statin
High dose statin use on patients with diabetes	Baseline	Proportion of patients with diabetes on high dose statin
Statin use on patients with previous stroke	Baseline	Proportion of patients with previous stroke on statin use
High dose statin use on patients with unknown diagnosis	Baseline	Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on high dose statin use

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, SP, Brazil