A retrospective nationwide analysis of evolocumab use in Sweden and its effect on low-density lipoprotein cholesterol levels.

Background: Treatment with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors reduces low-density lipoprotein cholesterol (LDL-C) levels and decreases the incidence of major ischaemic events in clinical trials. However, less is known about the efficacy of PCSK9 inhibition in clinical practice. This study aimed to describe the change in LDL-C levels over time and LDL-C goal achievement in patients with/without atherosclerotic cardiovascular disease (ASCVD), who were prescribed evolocumab in clinical practice, and to describe adherence to and persistence with treatment.
Methods: Patients in Sweden with at least one evolocumab prescription filled between July 2015 and May 2020 were included. Medical history and lipid-lowering therapy (LLT) were sourced from national registries. LDL-C levels before and after treatment initiation were assessed using medical records. Persistence with and adherence to evolocumab and oral LLT were assessed up to 12 months after treatment initiation using the refill-gap method and proportion of days covered, respectively.
Results: Of the 2,360 patients with at least one prescription for evolocumab, 2,341 were included; 1,858 had ASCVD. Persistence with (76%) and adherence to (86%) evolocumab were high throughout the 12 months following initiation. Mean LDL-C levels decreased by 53% (95% confidence interval [CI]: 51-55%) in patients adherent to evolocumab ( n = 567) and 59% (95% CI: 55-63%) in patients adherent to evolocumab and oral LLT ( n = 186). Similar reductions in LDL-C were observed in patients with/without ASCVD. Reduced LDL-C levels remained stable during follow-up. Amongst patients adherent to evolocumab and those adherent to evolocumab and oral LLT, 23 and 55% achieved the LDL-C goal of <1.4 mmol/L, respectively.
Conclusions: The evolocumab LDL-C-lowering effect observed in clinical trials was confirmed in clinical practice in Sweden, particularly in patients also treated with oral LLT. During follow-up, adherence to and persistence with evolocumab were high, with stable reduced levels of LDL-C during observation.
Competing Interests: MKS was an employee at Amgen when this study was conducted and declares payment for expert testimony from Amgen and support for attending meetings and/or travel from Amgen. SJ declares grants or contracts from any entity as a steering committee member without personal reimbursement; consulting fees to their institution from Amgen, AstraZeneca and Jansen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic; and participation on a data safety monitoring board or advisory board for MedPace. ARF has nothing to declare. GV and LS are Amgen employees and hold Amgen stock. TC is a co-owner of Sence Research (an independent company in epidemiology and biostatistics with both healthcare authorities and private companies as clients) and declares support from Amgen for statistical analyses within this research project; declares grants or contracts to Sence Research from different clients, but no payments directly to TC; declares consulting fees to Sence Research from different clients, but no payments directly to TC; and is a stock-owner of Sence Research. SG is an employee at Sence Research AB. EH declares grants or contracts from Pfizer and Amgen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Amgen, NovoNordisk, Bayer, AstraZeneca, Amarin and Novartis; participation on a data safety monitoring board or advisory board for Amarin AB, Amgen, Sanofi and Novartis; and leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid, as a co-chair of the Swedish secondary prevention registry, national coordinator DalCore: DAL301 DalGene, and R1500-CL-1643; Aegis II/Perfuse.
(© 2024 The Author(s). Published by Upsala Medical Society.)