RWE-Statins: Real World Evidence Study of Statin Use in Brazil

• Sponsor: Hospital Israelita Albert Einstein (Other)
• Overall Status: Completed
• CT.gov ID: NCT05285085
• Collaborator: epHealth (Other), Novartis (Industry)
• Enrollment: 2,133,900
• Location: 1
• Actual Duration (Days): 26
• Patients Per Site Per Month: 2498099.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Myocardial Infarction; Stroke; Hypertension; Diabetes Mellitus; Dyslipidemias	Drug: Statin

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 Design

• Study Type: Observational
• Actual Enrollment: 2133900 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Real World Evidence Study for Assessing Statin Use for Primary and Secondary Prevention of Cardiovascular Disease in Primary Care in Brazil
• Actual Study Start Date: Nov 19, 2021
• Actual Primary Completion Date: Dec 15, 2021
• Actual Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Secondary prevention Individuals with previous myocardial infarction and/or stroke	Drug: Statin; Statin use; Other Names: simvastatin calcium rosuvastatin atorvastatin pitavastatin pravastatin lovastatin rosuvastatin
Primary prevention Individuals with hypertension, diabetes and/or dyslipidemia	Drug: Statin; Statin use; Other Names: simvastatin calcium rosuvastatin atorvastatin pitavastatin pravastatin lovastatin rosuvastatin
Unknown diagnosis Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia	Drug: Statin; Statin use; Other Names: simvastatin calcium rosuvastatin atorvastatin pitavastatin pravastatin lovastatin rosuvastatin

Outcome Measures

Primary Outcome Measures

1. Statin use on secondary prevention [Baseline]

   Proportion of patients with previous myocardial infarction and/or stroke on statin use

2. Statin use on primary prevention [Baseline]

   Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use

Secondary Outcome Measures

1. Statin use on patients with previous myocardial infarction [Baseline]

   Proportion of patients with previous myocardial infarction on statin use

2. Statin use on patients with previous stroke [Baseline]

   Proportion of patients with previous stroke on statin use

3. High dose statin use on secondary prevention [Baseline]

   Proportion of patients with previous myocardial infarction and/or stroke on high dose statin use

4. High dose statin use on patients with previous myocardial infarction [Baseline]

   Proportion of patients with previous myocardial infarction on high dose statin

5. High dose statin use on patients with stroke [Baseline]

   Proportion of patients with previous stroke on high dose statin

6. Statin use on patients with diabetes [Baseline]

   Proportion of patients with diabetes on statin use

7. Statin use on patients with hypertension [Baseline]

   Proportion of patients with hypertension on statin use

8. Statin use on patients with dyslipidemia [Baseline]

   Proportion of patients with dyslipidemia on statin use

9. High dose statin use on patients with diabetes [Baseline]

   Proportion of patients with diabetes on high dose statin

10. High dose statin use on patients with hypertension [Baseline]

    Proportion of patients with hypertension on high dose statin

11. High dose statin use on patients with dyslipidemia [Baseline]

    Proportion of patients with dyslipidemia on high dose statin

12. 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

13. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Israelita Albert Einstein	São Paulo	SP	Brazil	04561-000

Sponsors and Collaborators

• Hospital Israelita Albert Einstein
• epHealth
• Novartis

Investigators

• Principal Investigator: M. Julia Machline-Carrion, PhD, epHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Israelita Albert Einstein
• ClinicalTrials.gov Identifier: NCT05285085
• Other Study ID Numbers: 53194121.0.0000.0071
• First Posted: Mar 17, 2022
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital Israelita Albert Einstein: cardiovascular diseases; primary prevention; secondary prevention; statins
• Additional relevant MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Dyslipidemias; Infarction; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin; Pitavastatin; Lovastatin

Study Results

No Results Posted as of Mar 17, 2022