Evidence map›Paper›PMID 36978066›Full record

Trial reportCardiovascular diabetology2023

Time-dependent event accumulation in a cardiovascular outcome trial of patients with type 2 diabetes and established atherosclerotic cardiovascular disease.

M Angelyn Bethel, Harald Sourij, Susanna R Stevens, Karen Hannan, Yuliya Lokhnygina, Amanda I Adler, Eric D Peterson, Rury R Holman, Renato D Lopes

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

Trial report in Cardiovascular diabetology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00790205 (TECOS), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT00790205 phase3completednot on this map

TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2008 to 2015Enrolled14,671ConditionsType 2 Diabetes MellitusArmsSitagliptin, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Dipeptidyl peptidase-4 deficiency prevents chronic stress-induced cardiac remodeling and dysfunction in mice.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2025
    Article
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

9 authors.

M Angelyn BethelDiabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Harald SourijInterdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
Susanna R StevensDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Karen HannanDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Yuliya LokhnyginaDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Amanda I AdlerDiabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Eric D PetersonDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Rury R HolmanDiabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Renato D LopesDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA. renato.lopes@dm.duke.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEstimating cardiovascular (CV) event accrual is important for outcome trial planning. Limited data exist describing event accrual patterns in patients with type 2 diabetes (T2D). We compared apparent CV event accrual patterns with true event rates in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).

methodsCentrally adjudicated event dates and accrual rates for a 4-point major adverse CV event composite (MACE-4; includes CV death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina hospitalization), MACE-4 components, all-cause mortality (ACM), and heart failure hospitalization were compiled. We used three graphical methods (Weibull probability plot, plot of negative log of the Kaplan-Meier survival distribution estimate, and the Epanechnikov kernel-smoothed estimate of the hazard rate) to examine hazard rate morphology over time for the 7 outcomes.

resultsPlots for all outcomes showed real-time constant event hazard rates for the duration of the follow-up, confirmed by Weibull shape parameters. The Weibull shape parameters for ACM (1.14, 95% CI 1.08-1.21) and CV death (1.08, 95% CI 1.01-1.16) were not sufficiently > 1 as to require non-constant hazard rate models to accurately depict the data. The time lag between event occurrence and event adjudication being completed, the adjudication gap, improved over the course of the trial.

conclusionsIn TECOS, the nonfatal event hazard rates were constant over time. Small increases over time in the hazard rate for fatal events would not require complex modelling to predict event accrual, providing confidence in traditional modelling methods for predicting CV outcome trial event rates in this population. The adjudication gap provides a useful metric to monitor within-trial event accrual patterns. CLINICAL

trial registrationClinicaltrials.gov NCT00790205.

Indexed as

AtherosclerosisCardiovascular DiseasesDiabetes Mellitus, Type 2Myocardial InfarctionHumansHypoglycemic AgentsSitagliptin PhosphateHypoglycemic AgentsSitagliptin PhosphateAdjudicationCardiovascular outcomesMyocardial infarctionStrokeType 2 diabetes

Identifiers

PMID36978066
PMCPMC10054031

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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.