Asia-Pacific Real-World Evolocumab Use, LDL-C Reduction, Physician Goals, and Patient Perceptions: HALES Observational Study

Abstract

Introduction: Real-world data are needed to understand the effectiveness of new therapeutic options for low-density lipoprotein cholesterol (LDL-C) reduction in Asia-Pacific clinical practice. Description of evolocumab use among adults with establisHed Atherosclerotic cardiovascuLar diseasE or hypercholesterolemia in ASia-Pacific region (HALES) was performed to better understand characteristics of and clinical decision-making for adults with established atherosclerotic cardiovascular disease/hypercholesterolemia after local evolocumab approval.

Methods: The HALES observational study, conducted at 33 sites (Hong Kong, Thailand, South Korea, Singapore, Taiwan, and Australia) comprised (1) chart review of patients who received evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), and (2) physician/patient survey and one-time data collection of patients with high cardiovascular risk initiating evolocumab or initiating/continuing non-PCSK9i lipid-lowering therapy. Patients could only enroll in (1) or (2).

Results: Chart review included 724 very high-risk patients initiating evolocumab from regulatory approval to 2021. From median baseline LDL-C of 3.2 mmol/L (123.7 mg/dL), patients had a median percent change in LDL-C of - 60.8% at 1-6 months. Goal achievement increased from 7.9% to 69.8% for < 1.8 mmol/L (< 70 mg/dL) and 4.4% to 57.8% for < 1.4 mmol/L (< 55 mg/dL) from baseline to 12 months. In the one-time data collection, more patients had ≥ 1.8 mmol/L (≥ 70 mg/dL) baseline LDL-C in the evolocumab vs non-PCSK9i group (95.2% and 48.5%, respectively). Surveys found that physicians applied guideline-recommended treatment targets, and patients demonstrated gaps in understanding cardiovascular risk.

Conclusion: Real-world, Asia-Pacific data showed that LDL-C reduction after initiating evolocumab was consistent with that observed in other clinical trials and patient populations. Graphical abstract available for this article.·.

Keywords: Asia; Australia; Cardiovascular event reduction; Chart review; Evolocumab; LDL-C reduction; Observational research; Patient-reported outcome; Physician feedback; Real-world evidence.

Fig. 1

Study design schema. ^aGrundy et al. Circulation 2019;139:e1082–e1143. ^bMach et al. Eur Heart J 2020;41:111–188. ACC American College of Cardiology, AHA American Heart Association, ASCVD atherosclerotic cardiovascular disease, CV cardiovascular, EAS European Atherosclerosis Society, ESC European Society of Cardiology, LDL-C low-density lipoprotein cholesterol, LLT lipid-lowering therapy, PCSK9i proprotein convertase subtilisin/kexin type 9 inhibitor

Fig. 2

Lipid-lowering therapy use in chart review assessment of evolocumab. High- and moderate-intensity statin and ezetimibe use before and after evolocumab initiation

Fig. 3

LDL-C change among patients in chart review assessment of evolocumab. a LDL-C median percent change from baseline to months 1–6 and months 7–12 after evolocumab initiation. b Proportion of patients at/below LDL-C thresholds (< 1.8 mmol/L [< 70 mg/dL], < 1.4 mmol/L [< 55 mg/dL], < 1.0 mmol/L [< 40 mg/dL) from baseline to 12 months. The baseline period was up to 12 months before the date of first administration of evolocumab for each patient (the index date). LDL-C low-density lipoprotein cholesterol