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Cited by 30Lipoproteins and Cardiovascular HealthMedication Adherence and ComplianceHeart Failure Treatment and Management

Long-term treatment adherence to the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in 6 ODYSSEY Phase III clinical studies with treatment duration of 1 to 2 years

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Farnier, Michel, Colhoun, Helen M., Sasiela, William J., Edelberg, Jay M., Asset, Gaëlle, Robinson, Jennifer G.·2017·Journal of Clinical Lipidology
DOI 10.1016/j.jacl.2017.05.016
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Abstract

BACKGROUND: Nonadherence to cardiovascular medications, including daily, oral statin therapy, negatively impacts outcomes in patients requiring low-density lipoprotein cholesterol (LDL-C)-lowering therapy. The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab also reduces LDL-C, but has a different mode of administration (subcutaneous injection). OBJECTIVE: The objective of the study was to assess long-term adherence to alirocumab 75 or 150 mg, given every 2 weeks, in phase III trials of patients with sub-optimally controlled hypercholesterolemia. METHODS: Data were pooled from 6 ODYSSEY trials (n = 4212) with double-blind treatment durations of 52 to 104 weeks. Adherence was reported as percentage of days receiving injections according to dosing schedule and categorized into 100% adherence, below-planned dosing, above-planned dosing, and both below- and above-planned dosing. Overall adherence was calculated as 100 - (percentage of days with below-planned dosing + percentage of days with above-planned dosing). Safety of alirocumab and effect on LDL-C levels were also evaluated. RESULTS: Adherence was analyzed for 4197 patients (n = 2786 alirocumab; n = 1411 control). Mean overall adherence was high (alirocumab 98.0%; control 97.8%). Among patients receiving alirocumab, 45.7% were 100% adherent, 20.4% had below-planned dosing, 2.9% had above-planned dosing, and 31.1% had both below- and above-planned dosing. Mean percentage reduction in LDL-C (baseline to Week 52) was 45.8% to 61.9%, depending on alirocumab dose, and was comparable across adherence categories. Treatment-emergent adverse events leading to alirocumab discontinuation were infrequent and included myalgia and injection-site reactions (<1% each). CONCLUSIONS: Alirocumab injections were associated with a high level of adherence over ≥1 year. Infrequent below- or above-planned dosing had minimal impact on LDL-C reductions.

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  • A pooled analysis of 6 randomized, double-blind, controlled ODYSSEY trials demonstrated high implementation to alirocumab, with mean overall treatment adherence 98.0% (SD 4.4) over 1 to 2 years.

    “A pooled analysis of 6 randomized, double-blind, controlled ODYSSEY trials, demonstrated high levels of implementation to alirocumab, with a mean (SD) overall treatment adherence of 98.0% (4.4) over 1 to 2 years.114”

    From Adherence to PCSK9 Inhibitors in Clinical Practice (2026) · cites this paper as [114]

    The Adherence section reports high mean overall adherence of 98.0% in the alirocumab arm, and the paper describes a pooled analysis of six randomized, double-blind, controlled ODYSSEY trials over 1 to 2 years. The passages available from our copy do not state the claimed SD of 4.4, so that numerical detail is not verified. (LLM, conf=0.83)

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Authors
Farnier, M., Colhoun, H. M., Sasiela, W. J., Edelberg, J. M., Asset, G., & Robinson, J. G.
Affiliations
  • CHU Dijon Bourgogne (FR)
  • University of Edinburgh (GB)
  • Regeneron (United States) (US)
  • Sanofi (United States) (US)
  • Sanofi (France) (FR)
  • University of Iowa (US)
Corresponding author
Farnier, Michel
ORCID
Venue
Journal of Clinical Lipidology
Publisher
Elsevier BV
Published
2017-07
Volume
11
Issue
4
Pages
986-997
ISSN
  • 1876-4789 (ISSN-L)
  • 1933-2874
DOI
10.1016/j.jacl.2017.05.016
OpenAlex
W2622520030
Cited by
30
References
4
Citations by year
2026: 2 · 2025: 1 · 2024: 1 · 2023: 5 · 2022: 2 · 2021: 6 · 2020: 2 · 2019: 5 · 2018: 3 · 2017: 3
FWCI
3.65
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of clinical lipidology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by-nc-nd)
Funders
  • Amgen
  • Eli Lilly and Company
  • Pfizer
  • AstraZeneca
  • GlaxoSmithKline
  • Sanofi
  • Regeneron Pharmaceuticals
  • Amarin Corporation
  • Kowa Company
  • Mylan
  • Eisai
  • Servier
  • Esperion Therapeutics
  • Genentech
  • Daiichi Sankyo Europe
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Keywords
alirocumab, PCSK9 inhibitors, medication adherence, subcutaneous injection, LDL cholesterol lowering, hypercholesterolemia, long-term treatment, ODYSSEY trial, treatment-emergent adverse events, injection site reactions, myalgia
MeSH terms
Treatment Adherence and Compliance, PCSK9 Inhibitors, Antibodies, Monoclonal, Double-Blind Method, Female, Humans, Hypercholesterolemia, Cholesterol, LDL, Male, Middle Aged, Protease Inhibitors, Safety, Time Factors, Antibodies, Monoclonal, Humanized

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