Skip to main content
construction release_alert
Scholars@Duke will be undergoing maintenance April 11-15. Some features may be unavailable during this time.
cancel
Journal cover image

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.

Publication ,  Journal Article
Scirica, BM; Im, K; Murphy, SA; Kuder, JF; Rodriguez, DA; Lopes, RD; Green, JB; Ruff, CT; Sabatine, MS
Published in: Clin Cardiol
July 2022

BACKGROUND: Trial 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. METHODS: TIMI 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. RESULTS: After 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, I2  = 62.07%). CONCLUSION: The 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.

Duke Scholars

Published In

Clin Cardiol

DOI

EISSN

1932-8737

Publication Date

July 2022

Volume

45

Issue

7

Start / End Page

794 / 801

Location

United States

Related Subject Headings

  • Sitagliptin Phosphate
  • Risk Factors
  • Hypoglycemic Agents
  • Humans
  • Hospitalization
  • Heart Failure
  • Dipeptidyl-Peptidase IV Inhibitors
  • Dipeptidyl Peptidase 4
  • Diabetes Mellitus, Type 2
  • Cardiovascular System & Hematology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Scirica, B. M., Im, K., Murphy, S. A., Kuder, J. F., Rodriguez, D. A., Lopes, R. D., … Sabatine, M. S. (2022). 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. Clin Cardiol, 45(7), 794–801. https://doi.org/10.1002/clc.23844
Scirica, Benjamin M., KyungAh Im, Sabina A. Murphy, Julia F. Kuder, Dolly A. Rodriguez, Renato D. Lopes, Jennifer B. Green, Christian T. Ruff, and Marc S. Sabatine. “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.Clin Cardiol 45, no. 7 (July 2022): 794–801. https://doi.org/10.1002/clc.23844.
Journal cover image

Published In

Clin Cardiol

DOI

EISSN

1932-8737

Publication Date

July 2022

Volume

45

Issue

7

Start / End Page

794 / 801

Location

United States

Related Subject Headings

  • Sitagliptin Phosphate
  • Risk Factors
  • Hypoglycemic Agents
  • Humans
  • Hospitalization
  • Heart Failure
  • Dipeptidyl-Peptidase IV Inhibitors
  • Dipeptidyl Peptidase 4
  • Diabetes Mellitus, Type 2
  • Cardiovascular System & Hematology