Evidence map›Paper›PMID 28244644›Full record

Trial reportDiabetes, obesity & metabolism2017

Optimizing the analysis strategy for the CANVAS Program: A prespecified plan for the integrated analyses of the CANVAS and CANVAS-R trials.

Bruce Neal, Vlado Perkovic, Kenneth W Mahaffey, Greg Fulcher, Ngozi Erondu, Mehul Desai, Wayne Shaw, Gordon Law, Marc K Walton, Norm Rosenthal and 3 more

Abstract readComparative StudyMulticenter 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 50 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 2 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

50 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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.

Bruce NealThe George Institute for Global Health, Sydney, Australia.ORCID 0000-0002-0490-7465
Vlado PerkovicThe George Institute for Global Health, Sydney, Australia.
Kenneth W MahaffeyDepartment of Medicine, Stanford Center for Clinical Research (SCCR), Stanford University, Stanford, California.
Greg FulcherRoyal North Shore Hospital and University of Sydney, Sydney, Australia.
Ngozi EronduJanssen Research & Development, LLC, Raritan, New Jersey.
Mehul DesaiJanssen Research & Development, LLC, Raritan, New Jersey.ORCID 0000-0003-3489-1967
Wayne ShawJanssen Research & Development, LLC, Raritan, New Jersey.
Gordon LawJanssen Research & Development, LLC, Raritan, New Jersey.
Marc K WaltonJanssen Research & Development, LLC, Raritan, New Jersey.
Norm RosenthalJanssen Research & Development, LLC, Raritan, New Jersey.
Dick de ZeeuwUniversity Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
David R MatthewsUniversity of Oxford, Oxford, UK.
CANVAS Program collaborative group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two large cardiovascular outcome trials of canagliflozin, comprising the CANVAS Program, will complete in early 2017: the CANagliflozin cardioVascular Assessment Study (CANVAS) and the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R). Accruing data for the sodium glucose co-transporter 2 (SGLT2) inhibitor class has identified questions and opportunities that were not apparent when the trials were designed. Accordingly, a series of modifications have been made to the planned analyses. These updates will ensure that the data from the CANVAS Program will maximize advances in scientific knowledge and patient care. The specification of the analysis strategy prior to knowledge of the trial results, their design by the independent scientific trial Steering Committee, the detailed a priori definition of the analysis plans, and the external review provided by the US Food and Drug Administration all provide maximally efficient and robust utilization of the data. The CANVAS Program should significantly advance our understanding of the effects of canagliflozin, and the broader SGLT2 inhibitor class, on a range of important efficacy and safety outcomes.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAgedBiomarkersCanagliflozinCardiovascular DiseasesCohort StudiesDiabetes Mellitus, Type 2Diabetic AngiopathiesDiabetic CardiomyopathiesDose-Response Relationship, DrugDouble-Blind MethodDrug MonitoringEquivalence Trials as TopicFemaleFollow-Up StudiesHumansBiomarkersCanagliflozinHypoglycemic AgentsSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 Inhibitorscardiovascular diseaseSGLT2 inhibitortype 2 diabetes

Identifiers

PMID28244644
PMCPMC5485085

What OpenQuestion 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 OpenQuestion graph.