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. 2021 May;44(5):715-722.
doi: 10.1002/clc.23600. Epub 2021 Mar 24.

Low-density lipoprotein cholesterol lowering in real-world patients treated with evolocumab

Nihar R Desai  1 , Rolin L Wade  2 , Pin Xiang  3   4 , Lionel Pinto  3 , Sasikiran Nunna  2   5 , Xin Wang  2 , Jason Exter  3 , Katherine E Mues  3 , Mohdhar Habib  3 , Chi-Chang Chen  2
Affiliations

Low-density lipoprotein cholesterol lowering in real-world patients treated with evolocumab

Nihar R Desai et al. Clin Cardiol. 2021 May.

Abstract

Background: Low-density lipoprotein cholesterol (LDL-C) is a risk factor for atherosclerotic cardiovascular disease (ASCVD). There are limited real-world data on LDL-C lowering with evolocumab in United States clinical practice.

Hypothesis: We assessed LDL-C lowering during 1 year of evolocumab therapy.

Methods: This retrospective cohort study used linked laboratory (Prognos) and medical claims (IQVIA Dx/LRx and PharMetrics Plus® ) data. Patients with a first fill for evolocumab between 7/1/2015 and 10/31/2019 (index event) and LDL-C ≥ 70 mg/dL were included (overall cohort; N = 5897). Additionally, a patient subgroup with a recent myocardial infarction (MI) within 12 months (median 130 days) before the first evolocumab fill was identified (N = 152). Reduction from baseline LDL-C was calculated based on the lowest LDL-C value recorded during a 12-month follow-up period.

Results: The mean (SD) age was 65 (10) years; 61.9% of patients had ASCVD diagnoses and 70.7% of patients were in receipt of lipid-lowering therapy. Following evolocumab treatment, changes in LDL-C from baseline were -60% in the overall cohort (median [interquartile range (IQR)] 146 [115-180] mg/dL to 58 [36-84] mg/dL) and -65% in the recent MI subgroup (median [IQR] 137 [109-165] mg/dL to 48 [30-78] mg/dL). In the overall cohort and recent MI subgroup, 62.1% and 69.7% of patients achieved LDL-C < 70 mg/dL, respectively.

Conclusions: In this real-world analysis, evolocumab was associated with significant reductions in LDL-C comparable to that seen in the FOURIER clinical trial, which were durable over 1 year of treatment.

Keywords: LDL-C; atherosclerotic cardiovascular disease; real-world evidence.

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Conflict of interest statement

Nihar R. Desai reports research grants from Medtronic, Johnson & Johnson; consulting fees from Amgen Inc., Relypsa, OPKO, scPharmaceuticals, and Cytokinetics. Rolin L. Wade, Xin Wang, Chi‐Chang Chen are employees of IQVIA, which was hired by Amgen to conduct this study. Pin Xiang was an employee of Amgen Inc. when the study was conducted and is an employee of Boehringer Ingelheim. Sasikiran Nunna was an employee of IQVIA when the study was conducted and is an employee of Bristol Myers Squibb. Lionel Pinto, Jason Exter, Katherine E. Mues, Mohdhar Habib are employees of Amgen Inc. and own Amgen stock.

Figures

FIGURE 1
FIGURE 1
Reduction in median LDL‐C from baseline over 1 year of treatment with evolocumab in the overall cohort and recent MI subgroup. Vertical bars represent interquartile ranges. LDL‐C, low‐density lipoprotein cholesterol; MI, myocardial infarction
FIGURE 2
FIGURE 2
Post‐index LDL‐C thresholds after initiating evolocumab in the overall cohort and recent MI subgroup. Based on the lowest LDL‐C value measured within 12 months after evolocumab initiation. LDL‐C, low‐density lipoprotein cholesterol; MI, myocardial infarction
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