Journal article
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
Journal of clinical lipidology, Vol.11(4), pp.986-997
07/2017
DOI: 10.1016/j.jacl.2017.05.016
PMID: 28693998
Abstract
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).
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.
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.
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).
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.
•Alirocumab is an injectable drug for hypercholesterolemia management.•Alirocumab adherence was assessed in a pooled analysis of 6 Phase III trials.•Long-term adherence (≥1 year) to alirocumab injections was high.•Alirocumab significantly reduced low-density lipoprotein cholesterol levels and was generally well tolerated.
Details
- Title: Subtitle
- 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
- Creators
- Michel Farnier - Lipid Clinic, Point Médical, Dijon, FranceHelen M Colhoun - University of Edinburgh, Edinburgh, UKWilliam J Sasiela - Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USAJay M Edelberg - Sanofi, Bridgewater, NJ, USAGaëlle Asset - Sanofi, Chilly-Mazarin, FranceJennifer G Robinson - University of Iowa, Iowa City, IA, USA
- Resource Type
- Journal article
- Publication Details
- Journal of clinical lipidology, Vol.11(4), pp.986-997
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.jacl.2017.05.016
- PMID
- 28693998
- ISSN
- 1933-2874
- eISSN
- 1876-4789
- Grant note
- Regeneron Pharmaceuticals, Inc (http://dx.doi.org/10.13039/100009857) Sanofi (http://dx.doi.org/10.13039/100004339) Regeneron Pharmaceuticals, Inc. (http://dx.doi.org/10.13039/100009857)
- Language
- English
- Date published
- 07/2017
- Academic Unit
- Epidemiology; Internal Medicine
- Record Identifier
- 9983996063002771
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