Among both African Americans and whites meeting the FOURIER clinical trial inclusion criteria, the cardiovascular disease (CVD) event rate was extremely high, and characteristics associated with a higher CVD risk may inform the decision to initiate proprotein convertase subtilisin/kexin (PCSK9) inhibition. This according to a recent study in which researchers analyzed data from 2,072 African American and 2,972 white REasons for Geographic and Racial Differences in Stroke (REGARDS) study participants aged 45-85 years with clinically evident CVD. Participants meeting the FOURIER inclusion criteria were followed for CVD events from baseline in 2003-2007 through 2014. Researchers found:
- Overall, 771 (37.2%) African Americans and 1,200 (40.4%) whites met the FOURIER inclusion criteria.
- The CVD event rate per 1,000 person-years was 60.6 among African Americans and 63.5 among whites.
- The risk for CVD events among adults meeting the FOURIER criteria was higher for those with a history of multiple CV events, a prior coronary revascularization, diabetes, reduced glomerular filtration rate, and albuminuria.
Colantonio LD, Monda KL, Rosenson RS, et al. Characteristics and cardiovascular disease event rates among African Americans and whites who meet further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial inclusion criteria. [Published online ahead of print February 11, 2019]. Cardiovasc Drugs Ther. doi:10.1007/s10557-019-06864-2.
PCSK9 inhibitors are very effective agents in lowering LDL cholesterol. Recent studies are defining patients most likely to achieve cardiovascular (CVD) event reduction from this therapy. The FOURIER clinical trial evaluated the efficacy of the PCSK9 inhibitor evolocumab on LDL cholesterol lowering and showed a significant reduction in cardiovascular events. Applying the inclusion criteria from the FOURIER trial to the REGARDS study population concluded that 37-40% of the participants met FOURIER inclusion criteria. The CVD event rate for this cohort in REGARDS was greater than 60 per 1,000 person-years. These databases are able to define high risk populations likely to benefit from a PCSK9 inhibitor, including individuals with multiple previous CVD events or revascularization, diabetes, or renal insufficiency. —Matthew Sorrentino, MD