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J Clin Lipidol. 2019 Nov - Dec;13(6):901-909.e3. doi: 10.1016/j.jacl.2019.10.003. Epub 2019 Oct 11.

Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: Results of the randomized, controlled, open-label DE LAVAL study.

Author information

1
Preventive Cardiology, Boca Raton, FL, USA. Electronic address: sjbaum@fpim.org.
2
Lipoapheresis Unit, Fondazione CNR Toscana Gabriele Monasterio, Pisa, Italy.
3
Lipid Unit, University Hospital Llandough, Penarth, Cardiff, United Kingdom.
4
Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
5
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.
6
Nephrological Center Villingen-Schwenningen, Villingen-Schwenningen, Germany; Extracorporeal Treatment and Lipoprotein Apheresis Center, Department of Internal Medicine III, University Hospital Carl Gustav Carus, Technische Universitaet, Dresden, Germany.

Abstract

BACKGROUND:

Lipoprotein apheresis (LA) can effectively lower lipoproteins but is an invasive procedure.

OBJECTIVE:

The objective of this study was to evaluate whether evolocumab can reduce LA requirement in patients undergoing chronic LA.

METHODS:

Patients on regular weekly or every-2-week LA and moderate- to high-intensity statin (if tolerated) with pre-LA low-density lipoprotein cholesterol (LDL-C) levels ≥2.6 mmol/L (100 mg/dL) to ≤4.9 mmol/L (190 mg/dL) were randomized to continue the same LA frequency, or discontinue LA and receive evolocumab 140 mg every-2-weeks subcutaneously for 6 weeks. At week 6, all patients received only open-label evolocumab for 18 weeks. The primary endpoint was LA avoidance at the end of 6 weeks based on achieving pre-LA LDL-C <2.6 mmol/L at week 4.

RESULTS:

Thirty-nine patients (mean [SD] age 62 [10] years, 59% male, 82% with familial hypercholesterolemia) were randomized (evolocumab, n = 19; LA, n = 20). At the end of 6 weeks, more patients receiving evolocumab avoided LA than those receiving LA (84% vs 10%; treatment difference, 74% [95% CI: 45, 87]; P < .0001). Thirty patients (77%) did not require LA at 24 weeks. Evolocumab reduced pre-LA LDL-C by 50% from the baseline to week 4 compared with a 3% increase in the LA arm. Pre-LA LDL-C <1.8 mmol/L (70 mg/dL) was achieved by 10 patients (53%) receiving evolocumab and none receiving LA (week 4). Safety was comparable between arms.

CONCLUSION:

Evolocumab treatment significantly reduced LA requirement in patients undergoing chronic LA. In addition, >50% of patients achieved LDL-C <1.8 mmol/L on evolocumab alone, demonstrating that in patients with pre-LA LDL-C ≤4.9 mmol/L, evolocumab may replace LA.

KEYWORDS:

Cardiovascular disease; Heterozygous familial hypercholesterolemia; Hypercholesterolemia; Lipoprotein apheresis; Monoclonal antibody; PCSK9

PMID:
31759938
DOI:
10.1016/j.jacl.2019.10.003
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