Evidence map›PCSK9 inhibitors × cardiovascular events›PMID 28927706›Full record

Trial reportThe lancet. Diabetes & endocrinology2017

Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial.

Marc S Sabatine, Lawrence A Leiter, Stephen D Wiviott, Robert P Giugliano, Prakash Deedwania, Gaetano M De Ferrari, Sabina A Murphy, Julia F Kuder, Ioanna Gouni-Berthold, Basil S Lewis and 6 more

Open access · greenAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2017. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. Cited by 250 papers, 9 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
250citing papers in PubMed, 9 pooled it
76.1field-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.

← favours the treatmentfavours the comparator →
1 · no effect
Cardiovascular eventsfavours the treatment · against placebo · ascvd, t2dfeeds one cell of the map
HR 0.830.75 to 0.93p=0.0008
For the primary composite endpoint, the hazard ratios (HRs) were 0.83 (95% CI 0.75-0.93; p=0.0008) for patients with diabetes and 0.87 (0.79-0.96; p=0.0052) for patients without diabetes (p INTERPRETATION: PCSK9 inhibition with evolocumab significantly reduced cardiovascular risk in patients with and without diabetes.
FeedsPCSK9 inhibitors×cardiovascular events

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

PCSK9 inhibitors×cardiovascular events

SupportsOpen on the map →What to test next →

10 readable studies in this cell: 7 favour the treatment, 3 find no difference, 0 favour the comparator.

Belief with this paper
1.00established · 6 families support, 0 contradict · against placebo
Without it
1.00This paper does not move the number.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2017
HR 0.830.75 to 0.93
NCT0176463327,564 enrolled · 2013
HR 0.850.79 to 0.92
NCT0166340218,924 enrolled · 2012
HR 0.850.78 to 0.93
NCT0387240112,301 enrolled · 2019
HR 0.750.65 to 0.86
Cardiovascular event reduction with PCSK9 inhibition among 1578 patien…PMID 29685591
HR 0.830.44 to 1.54
Efficacy and safety of alirocumab in reducing lipids and cardiovascula…PMID 25773378 · 2015
HR 0.520.31 to 0.90
Alirocumab after acute coronary syndrome in patients with a history of…PMID 34922353 · 2022
HR 0.850.78 to 0.93
Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Po…PMID 27777279 · 2016
HR 0.710.57 to 0.89
Cardiovascular Outcomes and Efficacy of the PCSK9 Inhibitor Evolocumab…PMID 40544474 · 2025
HR 0.660.32 to 1.38
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patient…PMID 28304242 · 2017
HR 0.880.76 to 1.02
4 · 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

250 citing papers in PubMed, 9 syntheses or guidelines pooled it, 587 citations in OpenAlex.

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190 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

16 authors at 13 institutions in 8 countries.

Marc S SabatineTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: msabatine@bwh.harvard.edu.
Lawrence A LeiterLi Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Stephen D WiviottTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Robert P GiuglianoTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Prakash DeedwaniaUCSF Fresno, Fresno, CA, USA.
Gaetano M De FerrariDepartment of Molecular Medicine, University of Pavia, and Cardiac Intensive Care Unit and Laboratories for Experimental Cardiology, IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.
Sabina A MurphyTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Julia F KuderTIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Ioanna Gouni-BertholdPolyclinic for Endocrinology, Diabetes, and Preventive Medicine, University of Cologne, Cologne, Germany.
Basil S LewisLady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-IIT, Haifa, Israel.
Yehuda HandelsmanMetabolic Institute of America, Tarzana, CA, USA.
Armando Lira PinedaAmgen, Thousand Oaks, CA, USA.
Narimon HonarpourAmgen, Thousand Oaks, CA, USA.
Anthony C KeechSydney Medical School, NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Peter S SeverInternational Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, UK.
Terje R PedersenOslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.
Amgen (United States) · USBrigham and Women's Hospital · USHarvard University · USCalifornia State University, Fresno · USCarmel Medical Center · ILImperial College London · GBTarzana Treatment Centers · USThrombolysis in Myocardial Infarction Study Group · USUniversity of Cologne · DEUniversity of Oslo · NOUniversity of Pavia · ITUniversity of Sydney · AUUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundThe proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes.

methodsFOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2·2 years. In this prespecified analysis, we investigated the effect of evolocumab on cardiovascular events by diabetes status at baseline, defined on the basis of patient history, clinical events committee review of medical records, or baseline HbA

findingsAt study baseline, 11 031 patients (40%) had diabetes and 16 533 (60%) did not have diabetes (of whom 10 344 had prediabetes and 6189 had normoglycaemia). Evolocumab significantly reduced cardiovascular outcomes consistently in patients with and without diabetes at baseline. For the primary composite endpoint, the hazard ratios (HRs) were 0·83 (95% CI 0·75-0·93; p=0·0008) for patients with diabetes and 0·87 (0·79-0·96; p=0·0052) for patients without diabetes (p

interpretationPCSK9 inhibition with evolocumab significantly reduced cardiovascular risk in patients with and without diabetes. Evolocumab did not increase the risk of new-onset diabetes, nor did it worsen glycaemia. These data suggest evolocumab use in patients with atherosclerotic disease is efficacious and safe in patients with and without diabetes.

fundingAmgen.

Indexed as

PCSK9 InhibitorsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBlood GlucoseCardiovascular DiseasesDiabetes MellitusDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsBlood GlucoseevolocumabPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9

Identifiers

PMID28927706
OpenAlexW2754562397

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

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.