Evidence map›Paper›PMID 26027630›Full record

Trial reportAmerican heart journal2015

Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study.

Dean J Kereiakes, Jennifer G Robinson, Christopher P Cannon, Christelle Lorenzato, Robert Pordy, Umesh Chaudhari, Helen M Colhoun

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

Trial report in American heart journal, 2015. 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 136 papers, 30 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 30 pooled it
53.4field-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 26638010PMID 25687353PMID 27892461PMID 16424354PMID 27668060PMID 3899825PMID 32827596PMID 31714973PMID 25606700other papers from this trial
Open the trial in the graph
NCT01644175 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

TypeinterventionalSponsorSanofiRan2012 to 2014Enrolled316ConditionsHypercholesterolemiaArmsPlacebo (for alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)
3 · Its place in the literature

Who cites it

136 citing papers in PubMed, 30 syntheses or guidelines pooled it, 343 citations in OpenAlex.

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  5. Benefits and Risks of Antihyperlipidemic Medication in Adults with Different Low-Density Lipoprotein Cholesterol Based on the Number Needed to Treat.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2024 · on this map
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  13. Biotechnology Approaches for the Treatment of Dyslipidemia.Cardiovascular drugs and therapy · 2021
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  15. 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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76 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

7 authors at 7 institutions in 3 countries.

Dean J KereiakesThe Christ Hospital, Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH. Electronic address: Lindner@thechristhospital.com.
Jennifer G RobinsonUniversity of Iowa, Iowa City, IA.
Christopher P CannonHarvard Clinical Research Institute, Boston, MA.
Christelle LorenzatoSanofi, Chilly-Mazarin, France.
Robert PordyRegeneron Pharmaceuticals, Inc, Tarrytown, NY.
Umesh ChaudhariSanofi, Bridgewater, NJ.
Helen M ColhounUniversity of Dundee, Dundee, Scotland, United Kingdom.
Baim Institute for Clinical Research · USChrist Hospital · USRegeneron (United States) · USSanofi (France) · FRSanofi (United States) · USUniversity of Dundee · GBUniversity of Iowa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ODYSSEY COMBO I study (http://clinicaltrials.gov/show/NCT01644175) evaluated efficacy and safety of alirocumab as add-on therapy to stable maximally tolerated daily statin with or without other lipid-lowering therapy in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia.

methodsThis multicenter, phase 3, randomized (2:1 alirocumab vs placebo), double-blind, 52-week trial enrolled 316 patients with established coronary heart disease or coronary heart disease risk equivalents and hypercholesterolemia. Alirocumab (75 mg every 2 weeks [Q2W]) or placebo Q2W was self-administered subcutaneously via 1 mL prefilled pen. The alirocumab dose was increased to 150 mg Q2W (also 1 mL) at week 12 if week 8 low-density lipoprotein cholesterol (LDL-C) was ≥70 mg/dL. The primary efficacy end point was percent change in LDL-C from baseline to week 24 (intention-to-treat analysis).

resultsAt week 24, estimated mean (95% CI) changes in LDL-C from baseline were -48.2% (-52.0% to -44.4%) and -2.3% (-7.6% to 3.1%) for alirocumab and placebo, respectively, an estimated mean (95% CI) difference of -45.9% (-52.5% to -39.3%) (P < .0001). Low-density lipoprotein cholesterol <70 mg/dL was achieved by 75% alirocumab versus 9% placebo patients at week 24. At week 12, 83.2% of evaluable alirocumab-treated patients remained on 75-mg Q2W. Treatment-emergent adverse events were comparable between groups.

conclusionsAlirocumab treatment achieved a significantly greater reduction in LDL-C and allowed a greater proportion of patients to achieve LDL-C goals, versus placebo after 24 weeks in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia at baseline despite receiving maximally tolerated statin with or without other lipid-lowering therapy. The frequency of treatment-emergent adverse events and study medication discontinuations were generally comparable between treatment groups.

Indexed as

AntibodiesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesCholesterol, LDLDouble-Blind MethodFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypercholesterolemiaMaleMiddle AgedProprotein Convertase 9Proprotein ConvertasesRisk FactorsSerine EndopeptidasesalirocumabAntibodiesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsPCSK9 protein, humanProprotein Convertase 9Proprotein ConvertasesSerine Endopeptidases

Identifiers

PMID26027630
OpenAlexW1985747185

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.