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Efficacy and Safety of Long-Term Evolocumab Use Among Asian Subjects - A Subgroup Analysis of the Further
Anthony C Keech1, Kazuma Oyama2,3, Peter S Sever4
1National Health and Medical Research Council Clinical Trials Centre, Sydney Medical School, University of Sydney.
Insights
Evolocumab effectively lowers LDL-C and reduces cardiovascular risks in Asian patients, demonstrating similar efficacy and safety compared to other populations in the FOURIER trial. This finding addresses concerns about differential drug responses.
Area of Science:
- Cardiovascular Medicine
- Pharmacogenomics
- Clinical Trials
Background:
- Concerns exist regarding potential ethnic differences in medication response, particularly among Asian patients.
- The FOURIER trial investigated the efficacy and safety of evolocumab in patients with atherosclerosis.
Purpose of the Study:
- To evaluate the efficacy and safety of evolocumab in Asian versus non-Asian participants within the FOURIER trial.
- To determine if evolocumab's lipid-lowering and cardiovascular benefits differ between racial groups.
Main Methods:
- A post-hoc analysis of 27,564 stable atherosclerosis patients from the FOURIER trial (evolocumab vs. placebo).
- Participants were categorized by self-reported race: Asian (n=2,723) and Other (n=24,841).
- Primary endpoint: composite of cardiovascular death, myocardial infarction, stroke, unstable angina hospitalization, or coronary revascularization over a median of 2.2 years.
Main Results:
- Asians had lower baseline LDL-C and were less likely to receive high-intensity statins compared to others.
- Evolocumab achieved greater LDL-C reduction in Asians (66%) versus others (58%).
- The cardiovascular benefit of evolocumab was consistent across racial groups (P interaction=0.55), with no increased serious adverse events in Asians.
Conclusions:
- Evolocumab is effective in lowering LDL-C and reducing cardiovascular event risk in Asian patients.
- The drug demonstrates comparable efficacy and safety in Asian individuals as observed in other populations.
- Findings support the use of evolocumab across diverse ethnic groups for managing atherosclerotic disease.
Background:
There are concerns that Asian patients respond differently to some medications. This study evaluated the efficacy and safety of evolocumab among Asian vs. other subjects in the FOURIER trial, which randomized stable atherosclerosis patients to receive either evolocumab or placebo.
Methods And Results:
Effects of adding evolocumab vs. placebo to background statin therapy on low-density lipoprotein cholesterol (LDL-C) reductions, cardiovascular outcomes, and adverse events were compared among 27,564 participants with atherosclerotic disease, according to self-reported Asian (n=2,723) vs. other (n=24,841) races followed for a median of 2.2 years in the FOURIER trial. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. At randomization, Asians had slightly lower LDL-C (median 89 [IQR 78-104] mg/dL vs. 92 [80-109] mg/dL; P<0.001) and were much less likely to be on a high-intensity statin (33.3% vs. 73.3%; P<0.001). Evolocumab lowered LDL-C more in Asians than in others (66% vs. 58%; P<0.001). The effect of evolocumab on the primary endpoint was similar in Asians (HR, 0.79; 95% CI, 0.61-1.03) and others (HR, 0.86; 95% CI, 0.79-0.93; P interaction=0.55). There was no excess of serious adverse events with evolocumab among Asians over others.
Conclusions:
Use of evolocumab robustly lowers LDL-C and is equally efficacious in lowering the risk of cardiovascular events and safe in Asians as it is in others.
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