Evidence map›Paper›PMID 27630212›Full record

Trial reportDiabetes care2017

Pancreatic Safety of Sitagliptin in the TECOS Study.

John B Buse, M Angelyn Bethel, Jennifer B Green, Susanna R Stevens, Yuliya Lokhnygina, Pablo Aschner, Carlos Raffo Grado, Tsvetalina Tankova, Julio Wainstein, Robert Josse and 6 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
6.7field-weighted citation impact, top 3% 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

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
  2. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. RSC advances · 2024
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 7 countries.

John B BuseUniversity of North Carolina School of Medicine, Chapel Hill, NC jbuse@med.unc.edu.
M Angelyn BethelDiabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K.
Jennifer B GreenDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Susanna R StevensDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Yuliya LokhnyginaDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Pablo AschnerPontificia Universidad Javeriana, Hospital Universitario San Ignacio, Bogotá, Colombia.
Carlos Raffo GradoCentre Region CINVEC, Viña del Mar, Chile.
Tsvetalina TankovaUniversity Specialized Hospital for Active Treatment in Endocrinology, Medical University, Sofia, Bulgaria.
Julio WainsteinE. Wolfson Medical Center, Holon, Israel.
Robert JosseSt. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
John M LachinThe George Washington University Biostatistics Center, Rockville, MD.
Samuel S EngelMerck & Co., Inc., Kenilworth, NJ.
Keyur PatelToronto Centre for Liver Disease, Division of Gastroenterology, University of Toronto Health Network, Toronto, Ontario, Canada.
Eric D PetersonDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
Rury R HolmanDiabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K.
TECOS Study Group
Clinical Research Institute · USDuke University · USUniversity of Oxford · GBGeorge Washington University · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USPontificia Universidad Javeriana · COToronto Liver Centre · CAUniversity of North Carolina at Chapel Hill · USUniversity of Toronto · CAUniversity Specialized Hospital for Active Treatment of Endocrinology · BGViña del Mar University · CLWolfson Medical Center · IL

Funding

North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
NCATS NIH HHS UL1 TR001111
6 · The paper itself

Abstract

objectiveWe evaluated the incidence of acute pancreatitis and pancreatic cancer in patients with type 2 diabetes and cardiovascular disease who were treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). RESEARCH DESIGN AND

methodsIn the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study, a cardiovascular safety study of sitagliptin, all suspected cases of acute pancreatitis and pancreatic cancer were collected prospectively for 14,671 participants during a median follow-up time of 3 years, and were adjudicated blindly.

resultsBaseline differences were minimal between participants confirmed to have no pancreatic events, acute pancreatitis, or pancreatic cancer. Among those participants randomized to receive sitagliptin, 23 (0.3%) (vs. 12 randomized to receive placebo [0.2%]) had pancreatitis (hazard ratio 1.93 [95% CI 0.96-3.88], P = 0.065; 0.107 vs. 0.056/100 patient-years), with 25 versus 17 events, respectively. Severe pancreatitis (two fatal) occurred in four individuals allocated to receive sitagliptin. Cases of pancreatic cancer were numerically fewer with sitagliptin (9 [0.1%]) versus placebo (14 [0.2%]) (hazard ratio 0.66 [95% CI 0.28-1.51], P = 0.32; 0.042 vs. 0.066 events/100 patient-years). Meta-analysis with two other DPP-4i cardiovascular outcome studies showed an increased risk for acute pancreatitis (risk ratio 1.78 [95% CI 1.13-2.81], P = 0.01) and no significant effect for pancreatic cancer (risk ratio 0.54 [95% CI 0.28-1.04], P = 0.07).

conclusionsPancreatitis and pancreatic cancer were uncommon events with rates that were not statistically significantly different between the sitagliptin and placebo groups, although numerically more sitagliptin participants developed pancreatitis and fewer developed pancreatic cancer. Meta-analysis suggests a small absolute increased risk for pancreatitis with DPP-4i therapy.

Indexed as

Acute DiseaseAgedCardiovascular DiseasesDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPancreatic NeoplasmsPancreatitisProportional Hazards ModelsRisk FactorsSitagliptin PhosphateDipeptidyl-Peptidase IV InhibitorsSitagliptin Phosphate

Identifiers

PMID27630212
PMCPMC5864139
OpenAlexW2519976593

What OpenQuestion holds

Textmetadata
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.