What is the clinical evidence from this study?

Study design: Cohort. Population: Hyperlipidemia with Atherosclerotic Cardiovascular Disease (ASCVD) (n=5897). Intervention: Evolocumab. Primary outcome: Percent change from baseline to the lowest median LDL-C recorded during 12-month follow-up.

What does this research mean for the field?

In a real-world clinical setting, evolocumab treatment reduces median LDL-C by 60% from baseline over 1 year of therapy in patients with baseline LDL-C ≥ 70 mg/dL. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

March 24, 2021Open Access

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

Key Result

In a real-world cohort of patients with LDL-C ≥ 70 mg/dL, evolocumab treatment reduced median LDL-C by 60% from baseline over 1 year of therapy.

Study Design

Type

Cohort (n=5,897)

Multicenter

Yes

Structured PICO

Does evolocumab reduce LDL-C in real-world patients with baseline LDL-C ≥ 70 mg/dL?

Population

5,897 patients with a first fill for evolocumab and LDL-C ≥ 70 mg/dL, including a subgroup of 152 patients with recent MI within 12 months. Mean age 65, 61.9% with ASCVD diagnoses, 70.7% on lipid-lowering therapy. United States clinical practice.

Intervention

Evolocumab therapy for 1 year

Outcome

Reduction from baseline LDL-C based on the lowest LDL-C value recorded during a 12-month follow-up periodsurrogate

In real-world US clinical practice, evolocumab significantly reduced LDL-C by 60% over 1 year, consistent with clinical trial data.

Limitations

Medical history in the LRx database may have been under-captured due to the open nature of the data
Limited generalizability to patients without health insurance
Unclear if patients used the product on the expected schedule as therapy was ascertained from prescriptions
Unable to assess physician and patient factors influencing treatment choice, such as statin intolerance
The recent MI subgroup was relatively small
Study ended shortly after the 2018 ACC/AHA blood cholesterol guideline was published, limiting observation of treatment pattern changes

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: ) 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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