Evidence map›Paper›PMID 26638010›Full record

Trial reportAtherosclerosis2016

Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial.

Michel Farnier, Peter Jones, Randall Severance, Maurizio Averna, Elisabeth Steinhagen-Thiessen, Helen M Colhoun, Yunling Du, Corinne Hanotin, Stephen Donahue

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Atherosclerosis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 84 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 24 pooled it
28.0field-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.

NCT06381947 phase4unknown statusstarted 2024, after this paper: background citation

Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients: a Randomized Crossover Trial

Ran2024Enrolled130Registered outcomes19Posted comparisons0ConditionsCardiovascular Diseases, Dyslipidemias, Lipid Metabolism Disorders, Statin Adverse ReactionArmsLipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe, Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe
PMID 26030325PMID 25825402PMID 30662020PMID 25687353PMID 26027630PMID 27892461PMID 16424354PMID 27668060PMID 3899825PMID 32827596PMID 31714973PMID 25606700other papers from this trial
Open the trial in the graph
NCT01730053 phase3completednot on this map

A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2012 to 2014Enrolled305ConditionsHypercholesterolemiaArmsAlirocumab, Rosuvastatin, Ezetimibe, Placebo
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 24 syntheses or guidelines pooled it, 186 citations in OpenAlex.

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  7. Biotechnology Approaches for the Treatment of Dyslipidemia.Cardiovascular drugs and therapy · 2021
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  9. 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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24 more citing papers are in PubMed but not listed here.

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 5 countries.

Michel FarnierPoint Médical, Dijon, France. Electronic address: michelfarnier@nerim.net.
Peter JonesBaylor College of Medicine, Houston, TX, USA.
Randall SeveranceRadiant Research - Phoenix SE, Chandler, AZ, USA.
Maurizio AvernaUniversità di Palermo - Policlinico "P. Giaccone", Palermo, Italy.
Elisabeth Steinhagen-ThiessenCharité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
Helen M ColhounUniversity of Dundee, Dundee, Scotland.
Yunling DuRegeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.
Corinne HanotinSanofi, Paris, France.
Stephen DonahueRegeneron Pharmaceuticals, Inc. Tarrytown, NY, USA.
Regeneron (United States) · USAzienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo · ITBaylor College of Medicine · USCharité - Universitätsmedizin Berlin · DERadiant Research (United States) · USSanofi (France) · FRUniversity of Dundee · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare lipid-lowering efficacy of adding alirocumab to rosuvastatin versus other treatment strategies (NCT01730053).

methodsPatients receiving baseline rosuvastatin regimens (10 or 20 mg) were randomized to: add-on alirocumab 75 mg every-2-weeks (Q2W) (1-mL subcutaneous injection via pre-filled pen); add-on ezetimibe 10 mg/day; or double-dose rosuvastatin. Patients had cardiovascular disease (CVD) and low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (1.8 mmol/L) or CVD risk factors and LDL-C ≥100 mg/dL (2.6 mmol/L). In the alirocumab group, dose was blindly increased at Week 12 to 150 mg Q2W (also 1-mL volume) in patients not achieving their LDL-C target. Primary endpoint was percent change in calculated LDL-C from baseline to 24 weeks (intent-to-treat).

results305 patients were randomized. In the baseline rosuvastatin 10 mg group, significantly greater LDL-C reductions were observed with add-on alirocumab (-50.6%) versus ezetimibe (-14.4%; p < 0.0001) and double-dose rosuvastatin (-16.3%; p < 0.0001). In the baseline rosuvastatin 20 mg group, LDL-C reduction with add-on alirocumab was -36.3% compared with -11.0% with ezetimibe and -15.9% with double-dose rosuvastatin (p = 0.0136 and 0.0453, respectively; pre-specified threshold for significance p < 0.0125). Overall, ∼80% alirocumab patients were maintained on 75 mg Q2W. Of alirocumab-treated patients, 84.9% and 66.7% in the baseline rosuvastatin 10 and 20 mg groups, respectively, achieved risk-based LDL-C targets. Treatment-emergent adverse events occurred in 56.3% of alirocumab patients versus 53.5% ezetimibe and 67.3% double-dose rosuvastatin (pooled data).

conclusionsThe addition of alirocumab to rosuvastatin provided incremental LDL-C lowering versus adding ezetimibe or doubling the rosuvastatin dose.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCardiovascular DiseasesCholesterol, LDLDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEzetimibeFollow-Up StudiesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaInjections, SubcutaneousRetrospective StudiesRosuvastatin CalciumalirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLEzetimibeHydroxymethylglutaryl-CoA Reductase InhibitorsRosuvastatin CalciumAlirocumabEzetimibeLow-density lipoprotein cholesterolMonoclonal antibodyPCSK9Rosuvastatin

Identifiers

PMID26638010
OpenAlexW2218353190

What Socratic holds

Texttitle and abstract
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.