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Characteristics and Cardiovascular Disease Event Rates among African Americans and Whites Who Meet the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) Trial Inclusion Criteria

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Abstract

Purpose

Determine the risk for cardiovascular disease (CVD) events among adults with clinically evident CVD who meet the inclusion criteria for the FOURIER clinical trial on PCSK9 inhibition in a real-world database.

Methods

We analyzed data from 2072 African American and 2972 white REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants 45–85 years of age with clinically evident CVD. Study participants meeting the FOURIER inclusion criteria (one major or two minor cardiovascular risk factors, fasting LDL cholesterol ≥ 70 mg/dL or non-HDL cholesterol ≥ 100 mg/dL, triglycerides ≤ 400 mg/dL, and taking statin) were followed for CVD events (myocardial infarction, stroke, coronary revascularization, and CVD death) from baseline in 2003–2007 through 2014.

Results

Overall, 771 (37.2%) African Americans and 1200 (40.4%) whites met the FOURIER inclusion criteria. The CVD event rate per 1000 person years was 60.6 (95% CI 53.6–67.6) among African Americans and 63.5 (95% CI 57.7–69.3) among whites. The risk for CVD events among adults meeting the FOURIER inclusion criteria was higher for those with a history of multiple cardiovascular events (hazard ratios among African Americans and whites 1.34 [95% CI 1.05–1.71] and 1.34 [1.10–1.63], respectively), a prior coronary revascularization (1.44 [1.13–1.84] and 1.23 [1.00–1.52], respectively), diabetes (1.38 [1.08–1.76] and 1.41 [1.15–1.72], respectively), reduced glomerular filtration rate (1.63 [1.26–2.11] and 1.29 [1.03–1.62], respectively), and albuminuria (1.77 [1.37–2.27] and 1.33 [1.07–1.65], respectively).

Conclusions

The CVD event rate is high among African Americans and whites meeting the FOURIER inclusion criteria. Characteristics associated with a higher CVD risk may inform the decision to initiate PCSK9 inhibition.

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Acknowledgements

The authors thank the other investigators, the staff, and the participants of the REGARDS study for their valuable contributions. A full list of participating REGARDS investigators and institutions and further information about the study can be found at http://www.regardsstudy.org.

Funding

The design and conduct of the study, interpretation of the results, and preparation of the manuscript was supported through a research grant from Amgen, Inc. (Thousand Oaks, CA). The academic authors conducted all analyses and maintained the rights to publish this article. The REGARDS study is supported by a cooperative agreement U01 NS041588 from the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Department of Health and Human Service. Representatives of the funding agency have been involved in the review of the manuscript but not directly involved in the collection, management, analysis, or interpretation of the data. Additional support was provided by grants R01 HL080477 and K24 HL111154 from the National Heart, Lung, and Blood Institute.

Author information

Authors and Affiliations

  1. Department of Epidemiology, University of Alabama at Birmingham, 1720 2nd Ave. South, RPHB 527C, Birmingham, AL, 35294-0013, USA

    Lisandro D. Colantonio & Paul Muntner

  2. Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA

    Keri L. Monda & Katherine E. Mues

  3. Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Robert S. Rosenson

  4. Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA

    Todd M. Brown

  5. Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA

    George Howard

  6. Department of Medicine, Weill Cornell Medical College, New York, NY, USA

    Monika M. Safford

  7. Amgen Inc., Thousand Oaks, CA, USA

    Larisa Yedigarova

  8. Peter Munk Cardiac Centre, University of Toronto and Heart and Stroke Richard Lewar Centre of Excellence, Toronto, ON, Canada

    Michael E. Farkouh

Authors
  1. Lisandro D. Colantonio
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  2. Keri L. Monda
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  9. Michael E. Farkouh
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Corresponding author

Correspondence to Lisandro D. Colantonio.

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Conflict of Interest

KLM, KEM, and LY are employed by Amgen, Inc. KLM and LY also are stockholders of Amgen, Inc. RSR, TMB, MMS, MEF, and PM receive research support from Amgen, Inc. RSR also receives research support from Akcea, Astra Zeneca, Medicines Company, Regeneron and Sanofi, serves on Advisory Boards for Akcea, Amgen, Inc., CVS Caremark, Easy Vitals, Regeneron and Sanofi, receives consulting fees and honoraria from Amgen, Regeneron, C5, CVS Caremark, Kowa and Pfizer, and receives royalties from UpToDate. TMB also receives research support from Astra Zeneca. PM also has received an honorarium from Amgen, Inc. LDC and GH have no disclosures.

Ethical Approval

All procedures performed in the current student were conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The REGARDS study protocol was approved by the Institutional Review Boards governing research in human subjects at the participating centers.

Informed Consent

Informed consent was obtained from all individual participants included in the REGARDS study.

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Colantonio, L.D., Monda, K.L., Rosenson, R.S. et al. Characteristics and Cardiovascular Disease Event Rates among African Americans and Whites Who Meet the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) Trial Inclusion Criteria. Cardiovasc Drugs Ther 33, 189–199 (2019). https://doi.org/10.1007/s10557-019-06864-2

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