Evidence map›Paper›PMID 28619659›Full record

Trial reportJournal of the American College of Cardiology2017

Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes.

James L Januzzi, Javed Butler, Petr Jarolim, Naveed Sattar, Ujjwala Vijapurkar, Mehul Desai, Michael J Davies

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

Trial report in Journal of the American College of Cardiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01106651. Cited by 89 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 10 pooled it
14.7field-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.

NCT01106651 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

Ran2010Enrolled716Registered outcomes14Posted comparisons28ConditionsDiabetes Mellitus, Type 2ArmsAntihyperglycemic agent(s), Canagliflozin 100 mg, Canagliflozin 300 mg, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 10 syntheses or guidelines pooled it, 213 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 2 countries.

James L JanuzziDepartment of Medicine/Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: jjanuzzi@partners.org.
Javed ButlerCardiology Division, Stony Brook University, Stony Brook, New York.
Petr JarolimDepartment of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Naveed SattarBritish Heart Foundation Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland.
Ujjwala VijapurkarJanssen Research & Development, LLC, Raritan, New Jersey.
Mehul DesaiJanssen Research & Development, LLC, Raritan, New Jersey.
Michael J DaviesJanssen Scientific Affairs, LLC, Titusville, New Jersey.
Janssen (United States) · USBrigham and Women's Hospital · USMassachusetts General Hospital · USStony Brook University · USUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSodium glucose co-transporter 2 inhibitors may reduce cardiovascular and heart failure risk in patients with type 2 diabetes mellitus (T2DM).

objectivesThe goal of this study was to examine the effects of canagliflozin on cardiovascular biomarkers in older patients with T2DM.

methodsIn 666 T2DM patients randomized to receive canagliflozin 100 or 300 mg or placebo, the study assessed the median percent change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity troponin I (hsTnI), soluble (s)ST2, and galectin-3 from baseline to 26, 52, and 104 weeks.

resultsBoth serum NT-proBNP and serum hsTnI levels increased in placebo recipients, but they remained largely unchanged in those randomized to canagliflozin. Hodges-Lehmann estimates of the difference in median percent change between pooled canagliflozin and placebo were -15.0%, -16.1%, and -26.8% for NT-proBNP, and -8.3%, -11.9%, and -10.0% for hsTnI at weeks 26, 52, and 104, respectively (all p < 0.05). Serum sST2 was unchanged with canagliflozin and placebo over 104 weeks. Serum galectin-3 modestly increased from baseline with canagliflozin versus placebo, with significant differences observed at 26 and 52 weeks but not at 104 weeks. These results remained unchanged when only patients with complete samples were assessed.

conclusionsCompared with placebo, treatment with canagliflozin delayed the rise in serum NT-proBNP and hsTnI for over 2 years in older T2DM patients. These cardiac biomarker data provide support for the beneficial cardiovascular effect of sodium glucose co-transporter 2 inhibitors in T2DM. (A Safety and Efficacy Study of Canagliflozin in Older Patients [55 to 80 Years of Age] With Type 2 Diabetes Mellitus; NCT01106651).

Indexed as

AgedAged, 80 and overBiomarkersBlood GlucoseCanagliflozinCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodFemaleFollow-Up StudiesHumansHypoglycemic AgentsMaleMiddle AgedNatriuretic Peptide, BrainPeptide FragmentsBiomarkersBlood GlucoseCanagliflozinHypoglycemic AgentsNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)Troponin Icardiovascular stressgalectin-3high-sensitivity troponinN-terminal pro–B-type natriuretic peptidesodium glucose co-transporter 2 inhibitorsoluble ST2

Identifiers

PMID28619659
OpenAlexW2625462710

What OpenQuestion holds

Texttitle and abstract
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.