Therapeutic Management of Dyslipidemia Patients at Very High Cardiovascular Risk (CARDIO TRACK): Protocol for the
Poobalan Naidoo1, Rashem Mothilal1, Dirk Jacobus Blom2
1Department of Medical Affairs, Sanofi South Africa, Johannesburg, South Africa.
Insights
This study assessed low-density lipoprotein cholesterol (LDL-C) goal achievement in high-risk South African patients on maximal statin therapy. Findings will inform future lipid-lowering therapy strategies in this population.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Dyslipidemia is a key modifiable risk factor for atherosclerotic cardiovascular disease.
- South African guidelines target low-density lipoprotein cholesterol (LDL-C) levels based on cardiovascular risk.
- A <1.8 mmol/L LDL-C goal is set for very high-risk patients, but achievement rates are poorly documented in South Africa.
Purpose of the Study:
- To evaluate LDL-C goal attainment in very high cardiovascular risk dyslipidemic patients receiving maximal statin therapy.
- To identify clinical characteristics of these patients.
- To assess the role of ezetimibe in combination with statins.
Main Methods:
- An observational, cross-sectional study conducted across up to 30 South African sites.
- Inclusion criteria: adult patients with very high cardiovascular risk on stable, maximally tolerated statin doses (with or without ezetimibe).
- Study enrolled 507 participants between November 2017 and April 2018.
Main Results:
- Enrollment and database lock completed in 2018.
- Statistical analysis commenced with final report expected by October 2018.
- Specific LDL-C goal achievement data and patient characteristics are pending final analysis.
Conclusions:
- The study addresses a critical data gap regarding lipid-lowering therapy (LLT) adequacy in high-risk South African patients.
- Results may guide the implementation of novel therapies, such as proprotein convertase subtilisin/kexin 9 inhibitors.
- Findings will aid in optimizing cardiovascular disease prevention strategies in South Africa.
Background:
Dyslipidemia is a major modifiable risk factor for atherosclerotic cardiovascular disease. Current South African guidelines recommend titrating lipid-lowering therapy (LLT) to low-density lipoprotein cholesterol (LDL-C) targets stratified by cardiovascular risk. The LDL-C goal for very high-risk patients is <1.8 mmol/L. In international studies, approximately 30% of patients do not achieve this goal despite receiving maximally tolerated statin doses. There is, however, a paucity of data on LDL-C goal achievement in very high-risk South African patients receiving maximal statin doses.
Objective:
The goal of the research it to assess LDL-C goal achievement in, and clinical characteristics of, very high cardiovascular risk dyslipidemic patients receiving maximal tolerated statin doses with or without ezetimibe.
Methods:
This is an observational, cross-sectional South African registry study that plans to include up to 30 sites and 500 study participants. Adult patients with very high cardiovascular risk status receiving stable, maximally tolerated statin doses (with or without ezetimibe) will be eligible for inclusion.
Results:
Funding has been awarded and enrollment began on November 15, 2017, and was completed on April 13, 2018, with 507 participants. Database lock was done on June 21, 2018. The statistical analysis has commenced and we expect the final clinical study report to be completed by October 2018.
Conclusions:
This study will document the adequacy of LLT in those at highest risk and will thus fill an important data gap in South Africa. This data may be useful in assessing the need for novel LLTs like proprotein convertase subtilisin/kexin 9 inhibitors that substantially lower cholesterol levels in addition to optimal statin therapy.
Registered Report Identifier:
RR1-10.2196/9248.
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