Evidence map›Paper›PMID 28206704›Full record

Trial reportDiabetes, obesity & metabolism2017

Lipid-lowering efficacy and safety of alirocumab in patients with or without diabetes: A sub-analysis of ODYSSEY COMBO II.

Lawrence A Leiter, José Luis Zamorano, Maja Bujas-Bobanovic, Michael J Louie, Guillaume Lecorps, Christopher P Cannon, Yehuda Handelsman

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

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

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Review
  10. Article
  11. Review
  12. Diabetes Mellitus and Cardiovascular Disease.Arteriosclerosis, thrombosis, and vascular biology · 2019
    Review
  13. Article
  14. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials.Diabetic medicine : a journal of the British Diabetic Association · 2018
    Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
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.

Lawrence A LeiterLi Ka Shing Knowledge Institute and Keenan Research Center for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto, Canada.ORCID 0000-0002-1040-6229
José Luis ZamoranoHospital Universitario Ramon y Cajal, University Alcala de Henares, Madrid, Spain.
Maja Bujas-BobanovicSanofi, Paris, France.
Michael J LouieRegeneron Pharmaceuticals, Tarrytown, New York.
Guillaume LecorpsSanofi, Paris, France.
Christopher P CannonBrigham and Women's Hospital, Boston, Massachusetts.
Yehuda HandelsmanMetabolic Institute of America, Tarzana, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThis sub-analysis of the ODYSSEY COMBO II study compared the effects of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in high cardiovascular risk patients with or without diabetes mellitus (DM) receiving maximally tolerated statin therapy.

methodsCOMBO II was a 104-week, double-blind study (n = 720) enrolling patients with documented atherosclerotic cardiovascular disease (ASCVD) and baseline LDL-C ≥70 mg/dL (1.8 mmol/L), and patients without documented ASCVD at high cardiovascular risk with LDL-C ≥100 mg/dL (2.6 mmol/L). Patients receiving maximally tolerated statin therapy were randomized (2:1) to alirocumab 75 mg every 2 weeks (Q2W; 1 mL subcutaneous injection) or oral ezetimibe 10 mg daily. Alirocumab dose was increased to 150 mg Q2W (also 1 mL) at Week 12 if Week 8 LDL-C was ≥70 mg/dL.

resultsHistory of DM was reported in 31% (n = 148) of patients on alirocumab and 32% (n = 77) of patients on ezetimibe. At Week 24, alirocumab consistently reduced LDL-C from baseline in patients with (-49.1%) or without DM (-51.2%) to a significantly greater extent than ezetimibe (-18.4% and -21.8%, respectively). Occurrence of treatment-emergent adverse events was similar between groups. Efficacy results at 104 weeks were similar to those at 24 weeks.

conclusionsOver a 104-week double-blind study period, alirocumab provided consistently greater LDL-C reductions than ezetimibe, with similar LDL-C results in patients with or without DM. Safety of alirocumab was similar regardless of baseline DM status.

Indexed as

PCSK9 InhibitorsAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesCholesterol, LDLCohort StudiesCombined Modality TherapyDiabetes ComplicationsDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesHealthy LifestyleHumansalirocumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCholesterol, LDLHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsPCSK9 InhibitorsSerine Proteinase Inhibitorscardiovascular diseaseclinical trialdyslipidaemiatype 1 diabetestype 2 diabetes

Identifiers

PMID28206704
PMCPMC5485164

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.