Evidence map›Paper›PMID 26330422›Full record

Trial reportEuropean heart journal2015

ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia.

John J P Kastelein, Henry N Ginsberg, Gisle Langslet, G Kees Hovingh, Richard Ceska, Robert Dufour, Dirk Blom, Fernando Civeira, Michel Krempf, Christelle Lorenzato and 6 more

6 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European 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 6 registered trials, which are not on this map. Cited by 218 papers, 31 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
218citing papers in PubMed, 31 pooled it
73.8field-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.

NCT03067844 phase3completedstarted 2017, after this paper: background citation

Effects of the PCSK9 Antibody AliroCuMab on Coronary Atherosclerosis in PatieNts With Acute Myocardial Infarction: A Serial, Multivessel, Intravascular Ultrasound, Near-Infrared Spectroscopy And Optical Coherence Tomography Imaging Study

Ran2017Enrolled294Registered outcomes16Posted comparisons0ConditionsAtheroma; Myocardial, Coronary Circulation, Coronary VesselArmsAlirocumab
PMID 25687353PMID 25773378PMID 25182248PMID 22019821PMID 22421222PMID 22421299PMID 23871513PMID 24239923PMID 24631113PMID 26655874PMID 27846344PMID 30336824other papers from this trial
Open the trial in the graph
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 26027630PMID 27892461PMID 16424354PMID 19768174PMID 26687696PMID 27039291PMID 27668060other papers from this trial
Open the trial in the graph
NCT01623115 phase3completednot on this map

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

TypeinterventionalSponsorSanofiRan2012 to 2014Enrolled486ConditionsHypercholesterolemiaArmsAlirocumab, Placebo (for alirocumab), Lipid Modifying Therapy (LMT)
NCT01709500 phase3completednot on this map

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

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2012 to 2015Enrolled249ConditionsHeterozygous Familial HypercholesterolemiaArmsLMT (atorvastatin, simvastatin, or rosuvastatin), alirocumab, Placebo
NCT06439654 narecruitingnot on this mapstarted 2024, after this paper: background citation

Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias

TypeinterventionalSponsorAtlantic Health SystemRan2024 to 2027Enrolled250ConditionsFamilial Hypercholesterolemia, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, Apolipoprotein B 100, Familial Defective, High Density Lipoprotein DeficiencyArmsSupportive care
NCT06592209 nacompletednot on this mapstarted 2023, after this paper: background citation

Body Electric: a Pragmatic Trial Evaluating Movement Breaks As a Public Health Strategy to Mitigate the Harms of Prolonged Sedentary Behavior

TypeinterventionalSponsorColumbia UniversityRan2023 to 2023Enrolled20,217ConditionsSedentary BehaviorArmsSedentary Breaks
3 · Its place in the literature

Who cites it

218 citing papers in PubMed, 31 syntheses or guidelines pooled it, 532 citations in OpenAlex.

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  7. 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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  14. Guideline
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  16. Biotechnology Approaches for the Treatment of Dyslipidemia.Cardiovascular drugs and therapy · 2021
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  17. 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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  19. Guideline
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158 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 8 countries.

John J P KasteleinDepartment of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room F4-159.2, 1105 AZ Amsterdam, The Netherlands j.j.kastelein@amc.uva.nl.
Henry N GinsbergColumbia University, New York, NY, USA.
Gisle LangsletLipid Clinic, Oslo University Hospital, Oslo, Norway.
G Kees HovinghDepartment of Vascular Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Room F4-159.2, 1105 AZ Amsterdam, The Netherlands.
Richard CeskaCenter of Preventive Cardiology, 1st School of Medicine and University Hospital, Charles University, Prague, Czech Republic.
Robert DufourInstitut de Recherches Cliniques de Montréal, Montréal, Canada.
Dirk BlomDivision of Lipidology, Department of Medicine, University of Cape Town and MRC Cape Heart Group, Cape Town, South Africa.
Fernando CiveiraLipid Unit, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Michel KrempfCHU de Nantes-Hôpital Nord Laennec, Saint-Herblain, France.
Christelle LorenzatoSanofi, Paris, France.
Jian ZhaoRegeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA.
Robert PordyRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Marie T Baccara-DinetSanofi, Montpellier, France.
Daniel A GipeRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Mary Jane GeigerRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Michel FarnierPoint Médical, Dijon, France.
Regeneron (United States) · USSanofi (France) · FRAcademic Medical Center · NLCharles University · CZColumbia University · USHospital Universitario Miguel Servet · ESMontreal Clinical Research Institute · CAOslo University Hospital · NOUniversity of Amsterdam · NLUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess long-term (78 weeks) alirocumab treatment in patients with heterozygous familial hypercholesterolaemia (HeFH) and inadequate LDL-C control on maximally tolerated lipid-lowering therapy (LLT). METHODS AND

resultsIn two randomized, double-blind studies (ODYSSEY FH I, n = 486; FH II, n = 249), patients were randomized 2 : 1 to alirocumab 75 mg or placebo every 2 weeks (Q2W). Alirocumab dose was increased at Week 12 to 150 mg Q2W if Week 8 LDL-C was ≥1.8 mmol/L (70 mg/dL). Primary endpoint (both studies) was percentage change in calculated LDL-C from baseline to Week 24. Mean LDL-C levels decreased from 3.7 mmol/L (144.7 mg/dL) at baseline to 1.8 mmol/L (71.3 mg/dL; -57.9% vs. placebo) at Week 24 in patients randomized to alirocumab in FH I and from 3.5 mmol/L (134.6 mg/dL) to 1.8 mmol/L (67.7 mg/dL; -51.4% vs. placebo) in FH II (P < 0.0001). These reductions were maintained through Week 78. LDL-C <1.8 mmol/L (regardless of cardiovascular risk) was achieved at Week 24 by 59.8 and 68.2% of alirocumab-treated patients in FH I and FH II, respectively. Adverse events resulted in discontinuation in 3.4% of alirocumab-treated patients in FH I (vs. 6.1% placebo) and 3.6% (vs. 1.2%) in FH II. Rate of injection site reactions in alirocumab-treated patients was 12.4% in FH I and 11.4% in FH II (vs. 11.0 and 7.4% with placebo).

conclusionIn patients with HeFH and inadequate LDL-C control at baseline despite maximally tolerated statin ± other LLT, alirocumab treatment resulted in significant LDL-C lowering and greater achievement of LDL-C target levels and was well tolerated. CLINICAL

trial registrationCinicaltrials.gov (identifiers: NCT01623115; NCT01709500).

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHeterozygoteHumansHyperlipoproteinemia Type IIMaleMiddle AgedRisk FactorsTreatment OutcomealirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCholesterol, LDLAlirocumabCardiovascular riskHeterozygous familial hypercholesterolaemiaLDL-CPCSK9

Identifiers

PMID26330422
PMCPMC4644253
OpenAlexW1962272706

What OpenQuestion 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 OpenQuestion graph.