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Published on: November 10, 2017
Low-density lipoprotein cholesterol lowering in real-world patients treated with evolocumab
Nihar R Desai1, Rolin L Wade2, Pin Xiang3,4
1Yale School of Medicine, New Haven, Connecticut, USA.
Insights
Evolocumab significantly reduced low-density lipoprotein cholesterol (LDL-C) by 60% in a real-world US study. These LDL-C lowering effects were durable for one year, comparable to clinical trial results.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Real-World Evidence
Background:
- Low-density lipoprotein cholesterol (LDL-C) is a key risk factor for atherosclerotic cardiovascular disease (ASCVD).
- Limited real-world data exist on the effectiveness of evolocumab in lowering LDL-C within the United States clinical practice.
- Understanding LDL-C reduction in routine care is crucial for managing ASCVD risk.
Purpose of the Study:
- To assess the efficacy of evolocumab in reducing LDL-C levels over a one-year period in a real-world US patient population.
- To evaluate the durability of LDL-C lowering effects of evolocumab.
- To compare real-world outcomes with findings from the FOURIER clinical trial.
Main Methods:
- Retrospective cohort study utilizing linked laboratory and medical claims data.
- Inclusion criteria: first fill of evolocumab between July 2015 and October 2019, with baseline LDL-C ≥ 70 mg/dL.
- Analysis included an overall cohort (N=5897) and a subgroup with recent myocardial infarction (N=152).
Main Results:
- Evolocumab treatment resulted in a 60% reduction in LDL-C in the overall cohort (median 146 to 58 mg/dL) and a 65% reduction in the recent MI subgroup (median 137 to 48 mg/dL).
- Over 62% of patients in the overall cohort and nearly 70% in the MI subgroup achieved LDL-C < 70 mg/dL.
- These LDL-C reductions were sustained throughout the one-year follow-up period.
Conclusions:
- Evolocumab demonstrated significant and durable LDL-C reductions in a real-world US setting.
- The observed LDL-C lowering was comparable to the efficacy reported in the FOURIER clinical trial.
- These findings support the use of evolocumab for managing LDL-C in patients at high cardiovascular risk in routine clinical practice.
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.
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