Long-term persistence with evolocumab treatment and sustained reductions in LDL-cholesterol levels over 30 months: Final results from the European observational HEYMANS study

Abstract

Background and aims: Variability in low-density lipoprotein-cholesterol (LDL-C) level control at a population level is associated with poor cardiovascular outcomes. Limited data exist on LDL-C level variability or long-term persistence with the monoclonal antibody evolocumab in routine clinical practice. Using data from the HEYMANS registry, this analysis aimed to assess evolocumab persistence and discontinuation over 30 months of evolocumab treatment and to evaluate at a population level the variability in LDL-C level reductions during the study period.

Methods: HEYMANS was a prospective registry of adults initiating evolocumab in routine clinical practice in 12 European countries. Data were collected for up to and including 6 months before evolocumab initiation and up to 30 months after. Evolocumab discontinuation was analysed for two time periods: 0-12 months and 12-30 months.

Results: In total, 1951 patients were included in the study. The median reduction in LDL-C levels was 58% within 3 months after evolocumab initiation; this reduction was maintained over 30 months. More than 90% of patients continued receiving evolocumab at 12 months and 30 months of follow-up. Of patients with an LDL-C level measurement during follow-up, approximately 85% achieved a ≥30% reduction from baseline at each follow-up visit and approximately 60% achieved a ≥50% reduction.

Conclusions: Evolocumab therapy was associated with sustained LDL-C level reductions up to 30 months, and persistence with evolocumab remained high, both at 12 and 30 months. Expanding the use of monoclonal antibodies such as evolocumab could provide improvements in LDL-C level control at a population level in European clinical practice.

Keywords: Cardiovascular; Dyslipidaemia; Evolocumab; Persistence; Registry.

Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: K.K.R. reports grants/personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cargene, Daiichi Sankyo, Esperion, Kowa, Lilly, New Amsterdam Pharma, Novartis, Pfizer, Sanofi-Regeneron, Silence Therapeutics and Scribe Therapeutics. E.B. reports consulting fees from Aegerion, AKCEA, Amarin, Amgen, Genfit, Ionis-pharmaceuticals, Lilly, MSD, Mylan, Novartis, Regeneron, Sanofi and Servier. P.P.F. reports consulting and speakers fees from Amgen. C.E. reports grants and personal fees from Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, Novo Nordisk and Sanofi. A.V. reports grants from Amgen, Novartis and Sanofi-Regeneron; and personal fees from Aegerion, Akcea, Amgen, Amryt, Daiichi Sankyo, Novartis and Sanofi-Regeneron. I.B. is an employee of Amgen Ltd and a stockholder of Amgen. N.D. is an employee of Amgen Inc and a stockholder of Amgen. M.S. is an employee of Amgen (Europe) GmbH and a stockholder of Amgen.

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