Lisandro D Colantonio1, Keri L Monda2, Robert S Rosenson3, Todd M Brown4, Katherine E Mues2, George Howard5, Monika M Safford6, Larisa Yedigarova7, Michael E Farkouh8, Paul Muntner9. 1. Department of Epidemiology, University of Alabama at Birmingham, 1720 2nd Ave. South, RPHB 527C, Birmingham, AL, 35294-0013, USA. lcolantonio@uab.edu. 2. Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA. 3. Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 4. Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. 5. Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA. 6. Department of Medicine, Weill Cornell Medical College, New York, NY, USA. 7. Amgen Inc., Thousand Oaks, CA, USA. 8. Peter Munk Cardiac Centre, University of Toronto and Heart and Stroke Richard Lewar Centre of Excellence, Toronto, ON, Canada. 9. Department of Epidemiology, University of Alabama at Birmingham, 1720 2nd Ave. South, RPHB 527C, Birmingham, AL, 35294-0013, USA.
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.
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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