Evidence mapPaperPMID 35715946Full record

SynthesisClinical cardiology2022

Re-adjudication of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) with study-level meta-analysis of hospitalization for heart failure from cardiovascular outcomes trials with dipeptidyl peptidase-4 (DPP-4) inhibitors.

Benjamin M Scirica, KyungAh Im, Sabina A Murphy, Julia F Kuder, Dolly A Rodriguez, Renato D Lopes, Jennifer B Green, Christian T Ruff, Marc S Sabatine

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in Clinical cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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.

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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. 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

9 authors at 2 institutions in 1 country.

Benjamin M SciricaTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-7093-7048
KyungAh ImTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Sabina A MurphyTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Julia F KuderTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Dolly A RodriguezTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Renato D LopesDuke Clinical Research Institute, Durham, North Carolina, USA.
Jennifer B GreenDuke Clinical Research Institute, Durham, North Carolina, USA.
Christian T RuffTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Marc S SabatineTIMI Study Group, Cardiovascular Medicine Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Brigham and Women's Hospital · USClinical Research Institute · US

Funding

Merck
6 · The paper itself

Abstract

backgroundTrial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) assessed the cardiovascular (CV) safety of sitagliptin versus placebo on CV outcomes in patients with type 2 diabetes and CV disease and found sitagliptin noninferior to placebo. Subsequently, based on feedback from FDA, the Sponsor of the trial, Merck & Co., Inc., engaged a separate academic research organization, the TIMI Study Group, to re-adjudicate a prespecified set of originally adjudicated events.

methodsTIMI adjudicated in a blinded fashion all potential hospitalization for heart failure (HHF) events, all potential MACE+ events previously adjudicated as not an endpoint event, and a random subset (~10%) of MACE+ events previously adjudicated as an endpoint event. An updated study-level meta-analysis of four randomized, placebo-controlled, CV outcomes trials with dipeptidyl peptidase 4 (DPP-4) inhibitors was then performed.

resultsAfter re-adjudication of potential HHF events in the intent-to-treat population, there were 224 patients with a confirmed event in the sitagliptin arm (1.05/100 person-years) and 239 patients in the placebo arm (1.13/100 person-years), corresponding to a hazard ratio (HR) of 0.94 (95% confidence interval [95% CI]: 0.78-1.13, p = .49). Concordance between the outcome of the original adjudication and the re-adjudication for HHF events was 82.7%. The meta-analysis of CV outcomes trials with DPP-4 inhibitors with placebo and involving 43 522 patients yielded an HR of 1.07 (95% CI: 0.83-1.39), with moderate heterogeneity (p = .45, I

conclusionThe results of this independent re-adjudication process and analyses of CV outcomes from TECOS were consistent with the original adjudication results and overall study findings. An updated study-level meta-analysis showed no overall significant risk for HHF with DPP-4 inhibitors, but with statistical heterogeneity.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsHeart FailureDipeptidyl Peptidase 4HospitalizationHumansHypoglycemic AgentsRisk FactorsSitagliptin PhosphateDipeptidyl Peptidase 4Dipeptidyl-Peptidase IV InhibitorsHypoglycemic AgentsSitagliptin Phosphatediabetesdipeptidyl peptidase-4 (DPP-4) inhibitorheart failuremeta-analysis

Identifiers

PMID35715946
PMCPMC9286326
OpenAlexW4283071187

What Socratic holds

Textmetadata
LicenceCC BY
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.