Evidence map›Paper›PMID 27625344›Full record

Trial reportJournal of the American Heart Association2016

Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study.

Erik Stroes, John R Guyton, Norman Lepor, Fernando Civeira, Daniel Gaudet, Gerald F Watts, Marie T Baccara-Dinet, Guillaume Lecorps, Garen Manvelian, Michel Farnier and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02023879 (A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin), which is not on this map. Cited by 47 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 15 pooled it
14.8field-weighted citation impact, top 1% 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.

NCT02023879 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin

TypeinterventionalSponsorSanofiRan2013 to 2017Enrolled233ConditionsHypercholesterolemiaArmsAlirocumab, Placebo (for Alirocumab), Non-statin LMT, Diet Alone
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 15 syntheses or guidelines pooled it, 100 citations in OpenAlex.

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  10. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2020 · on this map
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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

11 authors at 9 institutions in 6 countries.

Erik StroesDepartment of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands e.s.stroes@amc.uva.nl.
John R GuytonDuke University Medical Center, Durham, NC.
Norman LeporWestside Medical Associates of Los Angeles Cedars-Sinai Heart Institute, Beverly Hills, CA.
Fernando CiveiraLipid Unit, Hospital Universitario Miguel Servet, IIS Aragon, Zaragoza, Spain.
Daniel GaudetECOGENE-21 Clinical and Translational Research Center and Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.
Gerald F WattsLipid Disorders Clinic, Cardiovascular Medicine, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.
Marie T Baccara-DinetSanofi, Clinical Development, R&D, Montpellier, France.
Guillaume LecorpsSanofi, Chilly-Mazarin, France.
Garen ManvelianRegeneron Pharmaceuticals Inc, Tarrytown, NY.
Michel FarnierLipid Clinic, Point Médical, Dijon, France.
ODYSSEY CHOICE II Investigators
Sanofi (France) · FRAcademic Medical Center · NLDuke Medical Center · USRegeneron (United States) · USUniversité du Québec à Chicoutimi · CADuke University Hospital · USHospital Universitario Miguel Servet · ESUniversity of Western Australia · AUWestside Medical Associates of Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe PCSK9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low-density lipoprotein-cholesterol (LDL-C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin-associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone. METHODS AND

resultsPatients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL-C target levels were not met. The primary efficacy endpoint was LDL-C percentage change from baseline to W24. Mean baseline LDL-C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least-squares mean LDL-C changes from baseline to W24 were -51.7% and -53.5%, respectively (placebo [+4.7%]; both groups P<0.0001 versus placebo). In total, 63.9% and 70.3% of alirocumab-treated patients achieved their LDL-C targets at W24. Treatment-emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection-site reactions among the most common treatment-emergent adverse events.

conclusionsAlirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL-C. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02023879.

Indexed as

Diet TherapyAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLCombined Modality TherapyDouble-Blind MethodDrug Therapy, CombinationEzetimibeFemaleFenofibrateHumansHypercholesterolemiaHypolipidemic AgentsInjection Site ReactionalirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLEzetimibeFenofibrateHypolipidemic AgentsPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9alirocumabcardiovascular risklow‐density lipoprotein cholesterolplacebo‐controlledproprotein convertase subtilisin/kexin type 9

Identifiers

PMID27625344
PMCPMC5079013
OpenAlexW2518726365

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.