P6192Effects of evolocumab on LDL-C by race and ethnicity: an analysis of double-blind and open-label extension studies
Authors: Rodriguez C J , Daviglus M L , Lopez J A G , Wu Y , Monsalvo M L , Ferdinand K C 
Published: October 2019

Background/Introduction

Cardiovascular risk factors and clinical outcomes of atherosclerotic cardiovascular disease (ASCVD) vary amongst racial and ethnic groups.

Purpose

To examine the effects of evolocumab on low-density lipoprotein cholesterol (LDL-C) levels and achievement of LDL-C target goals by race or ethnicity.

Methods

Data from global phase 2 and 3 studies with at least 12 weeks of treatment with approved evolocumab doses vs. placebo or ezetimibe were included in this analysis (n=4375). Results were analysed by patient characteristics (statin intolerance, type 2 diabetes, heterozygous familial hypercholesterolaemia, and hypercholesterolaemia/mixed dyslipidaemia), self-identified race (White, Black/African American, and Asian), and self-identified ethnicity (Hispanic/Latino). Key outcomes included percent change in LDL-C, achievement of LDL-C <1.8 mmol/L (<70 mg/dL), and LDL-C achievement of at least 50% reduction.

Results

After 12-week evolocumab treatment, mean percent change in LDL-C from baseline ranged from approximately −52% to −59% for white patients to −49% to −67% for non-white patients, across all groups with adequate sample size (n>20) (Table). LDL-C <1.8 mmol/L was achieved in 43–84% of white patients and 62–94% of non-white patients receiving evolocumab (n>20). Similarly, 63–78% of white patients and 58–86% of non-white patients achieved at least a 50% reduction in LDL-C. The magnitude of treatment effect on mean percent change in LDL-C differed significantly only between white and non-white patients with diabetes (interaction p-values of treatment by race for evolocumab every 2 weeks p<0.001; once monthly p=0.007). This was driven by a greater reduction in Asian patients.

Mean (standard deviation) percent change in LDL-C levels from baseline, % Achievement of LDL-C <1.8 mmol/L (70 mg/dL)/LDL-C achievement of at least 50% reduction, % Population White Non-White Non-Hispanic Black or African American Asian Hispanic/Latino* White Non-White Non-Hispanic Black or African American Asian Hispanic/Latino* Statin-Intolerant† −55.4 (14.8) −46.3 (20.9) −46.0 (13.4) −49.0 (29.3) −54.6 (12.3) 42.9 / 68.6 26.7 / 60.0 14.3 / 42.9 50.0 / 83.3 0 / 66.7 n=210 n=15 n=7 n=6 n=3 Diabetes‡ −51.5 (25.6) −66.5 (21.2) −50.4 (22.2) −69.6 (20.2) −59.7 (20.5) 82.3 / 63.0 93.9 / 82.0 90.0 / 62.5 95.1 / 86.6 89.2 / 75.3 n=440 n=395 n=40 n=305 n=158 HeFH§ −57.3 (19.7) −64.1 (12.0) −73.8 (4.1) −60.5 (12.8) −35.8§§ 66.1 / 73.7 61.5 / 84.6 100 / 100 53.3 / 80.0 0 / 0 n=236 n=26 n=3 n=15 n=1 Hyper-cholesterolaemia/ −58.8 (19.2) −65.5 (17.0) −51.2 (19.4) −69.4 (13.9) −54.6 (20.3) 83.3 / 77.6 89.7 / 86.0 74.4 / 60.5 94.7 / 93.5 79.1 / 69.2   Mixed Dyslipidaemia¶ n=1399 n=437 n=86 n=339 n=91 Hyper-cholesterolaemia/ −59.4 (17.1) −58.4 (16.9) −52.8 (19.4) −65.8 (10.3) −56.7 (22.1) 80.2 / 78.5 85.7 / 75.7 82.4 / 67.6 96.7 / 93.3 77.3 / 68.2   Mixed Dyslipidaemia†† n=605 n=70 n=34 n=30 n=44 1-Year Study‡‡ −52.1 (27.7) −48.6 (29.2) −50.8 (22.0) −49.5 (29.4) −43.0 (43.1) 84.4 / 67.4 73.6 / 57.5 74.5 / 59.6 76.5 / 58.8 82.1 / 60.7 n=436 n=106 n=47 n=34 n=28 †GAUSS-1, -2 studies; ‡BANTING and BERSON studies; §RUTHERFORD-1, -2 studies; ¶Placebo comparator: MENDEL-1, -2, LAPLACE-TIMI-57, LAPLACE-2 and YUKAWA-1, -2 studies; ††Ezetimibe comparator: MENDEL-2 and LAPLACE-2 atorvastatin cohorts; ‡‡DESCARTES; §§Standard deviation could not be calculated due to insufficient sample size. *A total of 22 patients receiving evolocumab self-identified as Hispanic Black.

Conclusion

Reduction in LDL-C levels with evolocumab treatment was similar across race and ethnicity, apart from the diabetes population where Asian patients had a greater reduction in LDL-C.

Acknowledgement/Funding

Amgen Inc.