Evidence map›Paper›PMID 29263194›Full record

ArticleDiabetes care2018

Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a

William T Cefalu, Sanjay Kaul, Hertzel C Gerstein, Rury R Holman, Bernard Zinman, Jay S Skyler, Jennifer B Green, John B Buse, Silvio E Inzucchi, Lawrence A Leiter and 3 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes care, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02692716. Cited by 152 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
152citing papers in PubMed, 11 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.

NCT02692716 phase3completed

A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Ran2017Enrolled3,183Registered outcomes18Posted comparisons13ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsPlacebo, semaglutide
PMID 30284349PMID 31185157PMID 34277983PMID 35484580PMID 35373893other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

152 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Pooled it
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  10. Guideline
  11. Pooled it
  12. Trial
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  14. Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease.Clinical journal of the American Society of Nephrology : CJASN · 2020
    Trial
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  18. Review
  19. Article
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92 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

13 authors.

William T CefaluAmerican Diabetes Association, Arlington, VA wcefalu@diabetes.org.
Sanjay KaulCedars-Sinai Medical Center, Los Angeles, CA.ORCID 0000-0001-9640-4146
Hertzel C GersteinMcMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
Rury R HolmanDiabetes Trial Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K.
Bernard ZinmanLunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
Jay S SkylerDiabetes Research Institute, University of Miami Leonard M. Miller School of Medicine, Miami, FL.
Jennifer B GreenDuke University Medical Center, Durham, NC.
John B BuseUniversity of North Carolina School of Medicine, Chapel Hill, NC.ORCID 0000-0002-9723-3876
Silvio E InzucchiYale School of Medicine and Yale New Haven Hospital, New Haven, CT.ORCID 0000-0003-1254-6636
Lawrence A LeiterKeenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Departments of Medicine and Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.
Itamar RazDiabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.
Julio RosenstockDallas Diabetes Research Center at Medical City and The University of Texas Southwestern Medical Center, Dallas, TX.ORCID 0000-0001-8324-3275
Matthew C RiddleOregon Health & Science University, Portland, OR.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In December 2008, the U.S. Food and Drug Administration issued guidance to the pharmaceutical industry setting new expectations for the development of antidiabetes drugs for type 2 diabetes. This guidance expanded the scope and cost of research necessary for approval of such drugs by mandating long-term cardiovascular outcomes trials (CVOTs) for safety. Since 2008, 9 CVOTs have been reported, 13 are under way, and 4 have been terminated. Reassuringly, each of the completed trials demonstrated the noninferiority of their respective drugs to placebo for their primary cardiovascular (CV) composite end point. Notably, four additionally provided evidence of CV benefit in the form of significant decreases in the primary CV composite end point, two suggested reductions in CV death, and three suggested reductions in all-cause mortality. Although these trials have yielded much valuable information, whether that information justifies the investment of time and resources is controversial. In June 2016, a

Indexed as

AgedCardiovascular DiseasesCardiovascular SystemClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsEndpoint DeterminationFemaleFollow-Up StudiesGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlycoside Hydrolase InhibitorsHumansHypoglycemic AgentsInsulinDipeptidyl-Peptidase IV InhibitorsGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlycoside Hydrolase InhibitorsHypoglycemic AgentsInsulinSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID29263194
PMCPMC5741160

What Socratic 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 Socratic graph.