Real World Evidence Study of Statin Use in Brazil

NCT ID: NCT05285085

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2133900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-19

Study Completion Date

2021-12-15

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.

Conditions

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Cardiovascular Diseases Myocardial Infarction Stroke Hypertension Diabetes Mellitus Dyslipidemias

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Secondary prevention

Individuals with previous myocardial infarction and/or stroke

Statin

Intervention Type DRUG

Statin use

Primary prevention

Individuals with hypertension, diabetes and/or dyslipidemia

Statin

Intervention Type DRUG

Statin use

Unknown diagnosis

Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia

Statin

Intervention Type DRUG

Statin use

Interventions

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Statin

Statin use

Intervention Type DRUG

Other Intervention Names

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simvastatin calcium rosuvastatin atorvastatin pitavastatin pravastatin lovastatin rosuvastatin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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epHealth

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M. Julia Machline-Carrion, PhD

Role: PRINCIPAL_INVESTIGATOR

epHealth

Locations

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Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 37497398 (View on PubMed)

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.

Reference Type RESULT
PMID: 38431498 (View on PubMed)

Other Identifiers

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53194121.0.0000.0071

Identifier Type: -

Identifier Source: org_study_id

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