Clinical trial NCT05285085: Real World Evidence Study of Statin Use in Brazil
Official title: Real World Evidence Study for Assessing Statin Use for Primary and Secondary Prevention of Cardiovascular Disease in Primary Care in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Myocardial Infarction
Stroke
Hypertension
Diabetes Mellitus
Dyslipidemias
Keywords: cardiovascular diseases
primary prevention
secondary prevention
statins
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: epHealth
name: Novartis
First posted: 2022-03-17
Enrollment: 2133900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals aged 18 years or older registered on the epHealth database will be used in this study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Statin use on secondary prevention
timeFrame: Baseline
measure: Statin use on primary prevention
timeFrame: Baseline
Secondary outcomes:
measure: Statin use on patients with previous myocardial infarction
timeFrame: Baseline
measure: Statin use on patients with previous stroke
timeFrame: Baseline
measure: High dose statin use on secondary prevention
timeFrame: Baseline
measure: High dose statin use on patients with previous myocardial infarction
timeFrame: Baseline
measure: High dose statin use on patients with stroke
timeFrame: Baseline
measure: Statin use on patients with diabetes
timeFrame: Baseline
measure: Statin use on patients with hypertension
timeFrame: Baseline
measure: Statin use on patients with dyslipidemia
timeFrame: Baseline
measure: High dose statin use on patients with diabetes
timeFrame: Baseline
measure: High dose statin use on patients with hypertension
timeFrame: Baseline
measure: High dose statin use on patients with dyslipidemia
timeFrame: Baseline
measure: Statin use on patients with unknown diagnosis
timeFrame: Baseline
measure: High dose statin use on patients with unknown diagnosis
timeFrame: Baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
affiliation: epHealth
name: M. Julia Machline-Carrion, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machline-Carrion MJ, Girotto AN, Nieri J, Pereira PM, Monfardini F, Forestiero F, Raupp P, Roveda F, Santo K, Berwanger O, Santos RD. Assessing statins use in a real-world primary care digital strategy: a cross-sectional analysis of a population-wide digital health approach. Lancet Reg Health Am. 2023 Jun 22;23:100534. doi: 10.1016/j.lana.2023.100534. eCollection 2023 Jul.
citation: Santo K, Santos RD, Girotto AN, Nieri J, Monfardini F, Raupp P, Pereira PM, Berwanger O, Machline-Carrion MJ. Statins use for primary prevention of cardiovascular disease: A population-based digitally enabled real-world evidence cross-sectional study in primary care in Brazil. J Clin Lipidol. 2024 May-Jun;18(3):e384-e393. doi: 10.1016/j.jacl.2024.02.005. Epub 2024 Feb 20.