Evidence map›Paper›PMID 35316922›Full record

ArticleArchives of medical science : AMS2022

Treatment adherence and effect of concurrent statin intensity on the efficacy and safety of alirocumab in a real-life setting: results from ODYSSEY APPRISE.

Maciej Banach, José Luis López-Sendon, Maurizio Averna, Bertrand Cariou, Megan Loy, Garen Manvelian, Isabela Batsu, Yann Poulouin, Daniel Gaudet

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Archives of medical science : AMS, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02476006 (A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02476006 phase3completednot on this map

A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies

TypeinterventionalSponsorSanofiRan2015 to 2019Enrolled998ConditionsHypercholesterolemiaArmsALIROCUMAB SAR236553 (REGN727), placebo (for injection training only), ezetimibe, atorvastatin, rosuvastatin
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 24 citations in OpenAlex.

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  11. LDL lowering effect of PCSK9 inhibition is reduced in women.European heart journal. Cardiovascular pharmacotherapy · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 6 countries.

Maciej BanachDepartment of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland.
José Luis López-SendonHospital Universitario La Paz, IdiPaz, CIBER-CV, UAM, Madrid, Spain.
Maurizio AvernaDepartment of Health Promotion Sciences, Maternal and Infantile Care, Internal Medicine and Medical Specialties - PROMISE, School of Medicine, University of Palermo, Palermo, Italy.
Bertrand Carioul'institut du thorax, CHU Nantes, INSERM, CNRS, UNIV Nantes, Nantes, France.
Megan LoySanofi, Bridgewater, NJ, United States.
Garen ManvelianRegeneron Pharmaceuticals, Inc., Tarrytown, NY, United States.
Isabela BatsuSanofi, Bridgewater, NJ, United States.
Yann PoulouinIT&M Stats, Paris, France.
Daniel GaudetECOGENE-21 and Clinical Lipidology Unit, Community Gene Medicine Center, Department of Medicine, Université de Montréal, Chicoutimi, QC, Canada.
Sanofi (United States) · USCentre National de la Recherche Scientifique · FRHospital Universitario La Paz · ESMedical University of Lodz · PLRegeneron (United States) · USUniversité de Montréal · CAUniversity of Palermo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The phase IIIb open-label ODYSSEY APPRISE study prospectively assessed the safety and efficacy of alirocumab (a proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitor) in a real-life setting in high cardiovascular risk patients with heterozygous familial hypercholesterolemia or low-density lipoprotein cholesterol (LDL-C) not at goal despite maximally tolerated dose statins ± other lipid-lowering therapies (NCT02476006). This post-hoc analysis assessed patient adherence to statins and alirocumab, plus alirocumab efficacy and safety, according to concomitant statin intensity and prior ezetimibe usage. Material and methods: Patients received alirocumab 75 or 150 mg (dose adjustment based on physician's judgment) every 2 weeks (for ≥ 3 to ≤ 30 months). Results: Of 994 enrolled and treated patients, 58.4% received concomitant high-intensity statins, 18.2% received moderate/low-intensity statins, and 23.4% received no statin; 55.9% received prior ezetimibe. Mean alirocumab adherence (percent adherence defined as injections received/theoretical injections × 100) was 96.6% over 72.4 weeks' mean treatment duration. Mean LDL-C reduction from baseline at Week 12 was similar between statin intensity subgroups (53.6-55.7%). More patients achieved LDL-C < 1.8 mmol/l and/or ≥ 50% reduction from baseline in the ≥ 100% versus < 100% adherent to alirocumab subgroup; high-intensity and low/moderate-intensity subgroups versus no statin subgroup; and prior ezetimibe versus no prior ezetimibe subgroup. Treatment-emergent adverse events occurred in 65.2-75.1% and 68.0-76.3% of patients across statin and ezetimibe subgroups, respectively. Conclusions: In a real-life setting, patient adherence to alirocumab was high. Alirocumab provided clinically significant reductions in LDL-C, with most patients achieving LDL-C treatment targets across background statin therapy and prior ezetimibe therapy subgroups.

Indexed as

cholesterollow-density lipoproteinPCSK9treatment adherence

Identifiers

PMID35316922
PMCPMC8924821
OpenAlexW3211313464

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.