PCSK9 inhibition in clinical practice: Treatment patterns and attainment of lipid goals in a large health maintenance organization.

Cholesterol Drug adherence Low-density lipoprotein Monoclonal antibodies PCSK9

Journal

Journal of clinical lipidology
ISSN: 1933-2874
Titre abrégé: J Clin Lipidol
Pays: United States
ID NLM: 101300157

Informations de publication

Date de publication:
Historique:
received: 23 07 2020
revised: 30 10 2020
accepted: 09 11 2020
pubmed: 28 11 2020
medline: 26 11 2021
entrez: 27 11 2020
Statut: ppublish

Résumé

Proprotein convertase subtilisin/kexin type-9 inhibitors (PCSK9i) effectively reduce low-density lipoprotein cholesterol (LDL-C), improving cardiovascular outcomes in clinical trials when added to statin therapy. As real-world evidence is lacking, we aimed to evaluate treatment and adherence patterns using PCSK9i in clinical practice. We investigated 1600 patients initiating PCSK9i between January 2016 and December 2019 in a large health maintenance organization. Treatment discontinuation was defined as a gap ≥60 days between last days' supply of one prescription and the start of the next. Re-initiation rates as well as proportion of days covered (PDC) over 1-year period and attainment of lipid goals under PCSK9i, were analyzed. Evolocumab 140 mg was initiated by 50.7%, alirocumab 75 mg by 29.5% and 150 mg by 19.8%. Cumulative discontinuation rates were 28.1% after 6-months and 49.9% after 3-years. Overall, 58% of the patients that discontinued therapy have re-initiated PCSK9i (31% after 3-months from discontinuation). Mean PDC over 1-year of therapy was 56% ± 29, with PDC ≥80% evident in 29%. Of those with established cardiovascular disease (n = 991), 55% achieved LDL-C<70 mg/dL and 38% LDL-C<55 mg/dL. Attainment rates were lower in patients with PDC<80%, baseline LDL-C>190 mg/dL and in those not treated with concurrent statin therapy. In real-world practice of patients treated by PCSK9i, high proportion of early treatment discontinuation was evident, with non-negligible re-initiation rates but overall low medication coverage over time. This have contributed to sub-optimal attainment of LDL-C treatment goals, particularly observed in patients with severe hypercholesterolemia, inadequate drug adherence, and those using PCSK9i as monotherapy.

Sections du résumé

BACKGROUND
Proprotein convertase subtilisin/kexin type-9 inhibitors (PCSK9i) effectively reduce low-density lipoprotein cholesterol (LDL-C), improving cardiovascular outcomes in clinical trials when added to statin therapy.
OBJECTIVES
As real-world evidence is lacking, we aimed to evaluate treatment and adherence patterns using PCSK9i in clinical practice.
METHODS
We investigated 1600 patients initiating PCSK9i between January 2016 and December 2019 in a large health maintenance organization. Treatment discontinuation was defined as a gap ≥60 days between last days' supply of one prescription and the start of the next. Re-initiation rates as well as proportion of days covered (PDC) over 1-year period and attainment of lipid goals under PCSK9i, were analyzed.
RESULTS
Evolocumab 140 mg was initiated by 50.7%, alirocumab 75 mg by 29.5% and 150 mg by 19.8%. Cumulative discontinuation rates were 28.1% after 6-months and 49.9% after 3-years. Overall, 58% of the patients that discontinued therapy have re-initiated PCSK9i (31% after 3-months from discontinuation). Mean PDC over 1-year of therapy was 56% ± 29, with PDC ≥80% evident in 29%. Of those with established cardiovascular disease (n = 991), 55% achieved LDL-C<70 mg/dL and 38% LDL-C<55 mg/dL. Attainment rates were lower in patients with PDC<80%, baseline LDL-C>190 mg/dL and in those not treated with concurrent statin therapy.
CONCLUSIONS
In real-world practice of patients treated by PCSK9i, high proportion of early treatment discontinuation was evident, with non-negligible re-initiation rates but overall low medication coverage over time. This have contributed to sub-optimal attainment of LDL-C treatment goals, particularly observed in patients with severe hypercholesterolemia, inadequate drug adherence, and those using PCSK9i as monotherapy.

Identifiants

pubmed: 33243717
pii: S1933-2874(20)30330-5
doi: 10.1016/j.jacl.2020.11.004
pii:
doi:

Substances chimiques

Cholesterol, LDL 0
Hypolipidemic Agents 0
Proprotein Convertase 9 EC 3.4.21.-

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

202-211.e2

Informations de copyright

Copyright © 2020 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Auteurs

Barak Zafrir (B)

The Department of Cardiology, Lady Davis Carmel Medical Center, Haifa, Israel; The Faculty of Medicine, Technion, Israel Institute of Medicine, Haifa, Israel. Electronic address: barakzmd@gmail.com.

Aya Egbaria (A)

The Faculty of Medicine, Technion, Israel Institute of Medicine, Haifa, Israel.

Nili Stein (N)

The Statistical Unit, Lady Davis Carmel Medical Center, Haifa, Israel.

Avishay Elis (A)

The Department of Medicine, Beilinson Hospital, Rabin Medical Center, PetachTikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Walid Saliba (W)

The Faculty of Medicine, Technion, Israel Institute of Medicine, Haifa, Israel; The Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Haifa, Israel.

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