Evidence map›Paper›PMID 24255061›Full record

Trial reportCirculation2014

Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial.

Michael J Koren, Robert P Giugliano, Frederick J Raal, David Sullivan, Michael Bolognese, Gisle Langslet, Fernando Civeira, Ransi Somaratne, Patric Nelson, Thomas Liu and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01439880 (A Multicenter, Controlled, Open-label Extension), which is not on this map. Cited by 78 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 9 pooled it
37.2field-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.

NCT01439880 phase2completednot on this map

A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)

TypeinterventionalSponsorAmgenRan2011 to 2018Enrolled1,324ConditionsHypercholesterolemiaArmsEvolocumab, Standard of care
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 9 syntheses or guidelines pooled it, 216 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Biotechnology Approaches for the Treatment of Dyslipidemia.Cardiovascular drugs and therapy · 2021
    Pooled it
  5. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2020 · on this map
    Pooled it
  6. Pooled it
  7. Pooled it
  8. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2017 · on this map
    Pooled it
  9. Pooled it
  10. Trial
  11. Calorically restricted diets decrease PCSK9 in overweight adolescents.Nutrition, metabolism, and cardiovascular diseases : NMCD · 2017 · on this map
    Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Article
  17. Administration of Evolocumab in Patients with STEMI After Emergency PCI: A Real-World Cohort Study.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Article
  18. Review
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 4 countries.

Michael J KorenJacksonville Center for Clinical Research, Jacksonville, FL (M.J.K.); TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (R.P.G., M.S.S.); Carbohydrate and Lipid Metabolism Research Unit, Division of Endocrinology and Metabolism, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa (F.J.R.); Department of Clinical Biochemistry, Royal Prince Alfred Hospital, Camperdown, Australia (D.S.); Bethesda Health Research Center, Bethesda, MD (M.B.); Lipid Clinic, Oslo University Hospital, Oslo, Norway (G.L.); Hospital Universitario Miguel Servet, Zaragoza, Spain (F.C.); and Amgen Inc, Thousand Oaks, CA (R.S., P.N., T.L., R.S., S.M.W.).
Robert P Giugliano
Frederick J Raal
David Sullivan
Michael Bolognese
Gisle Langslet
Fernando Civeira
Ransi Somaratne
Patric Nelson
Thomas Liu
Rob Scott
Scott M Wasserman
Marc S Sabatine
OSLER Investigators
Oslo University Hospital · NOBrigham and Women's Hospital · USJacksonville Center for Clinical Research · USThrombolysis in Myocardial Infarction Study Group · USRoyal Prince Alfred Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvolocumab (AMG 145), a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein cholesterol (LDL-C) in phase 2 studies of 12 weeks' duration. The longer-term efficacy and safety of PCSK9 inhibition remain undefined. METHODS AND

resultsOf 1359 randomized and dosed patients in the 4 evolocumab phase 2 parent studies, 1104 (81%) elected to enroll into the Open-Label Study of Long-term Evaluation Against LDL-C (OSLER) study. Regardless of their treatment assignment in the parent study, patients were randomized 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care (SOC) (evolocumab+SOC, n=736) or SOC alone (n=368). Ninety-two percent of patients in the evolocumab+SOC group and 89% of patients in the SOC group completed 52 weeks of follow-up. Patients who first received evolocumab in OSLER experienced a mean 52.3% [SE, 1.8%] reduction in LDL-C at week 52 (P<0.0001). Patients who received 1 of 6 dosing regimens of evolocumab in the parent studies and received evolocumab+SOC in OSLER had persistent LDL-C reductions (mean reduction, 50.4% [SE, 0.8%] at the end of the parent study versus 52.1% [SE, 1.0%] at 52 weeks; P=0.31). In patients who discontinued evolocumab on entry into OSLER, LDL-C levels returned to near baseline levels. Adverse events and serious adverse events occurred in 81.4% and 7.1% of the evolocumab+SOC group patients and 73.1% and 6.3% of the SOC group patients, respectively.

conclusionEvolocumab dosed every 4 weeks demonstrated continued efficacy and encouraging safety and tolerability over 1 year of treatment in the largest and longest evaluation of a PCSK9 inhibitor in hypercholesterolemic patients to date. CLINICAL TRIAL REGISTRATION URL: http://clinicaltrials.gov. Unique identifier: NCT01439880.

Indexed as

AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLDose-Response Relationship, DrugFemaleHumansHypercholesterolemiaLongitudinal StudiesMaleMiddle AgedProprotein Convertase 9Proprotein ConvertasesSerine EndopeptidasesStandard of CareTime FactorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLevolocumabPCSK9 protein, humanProprotein Convertase 9Proprotein ConvertasesSerine Endopeptidasescholesterol, LDLhypercholesterolemiarandomized controlled trialserine proteases

Identifiers

PMID24255061
OpenAlexW2119475560

What OpenQuestion holds

Textmetadata
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.