Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: Observations from TECOS

Michael A. Nauck, Darren K McGuire, Karen S. Pieper, Yuliya Lokhnygina, Timo E. Strandberg, Axel Riefflin, Tuncay Delibasi, Eric D. Peterson, Harvey D. White, Russell Scott, Rury R. Holman

Research output: Contribution to journalArticle

Abstract

Background: To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Methods: TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses. Results: During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95% CI 0.81-1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15%) died subsequently, with 66 (11%) being CV deaths, and 57 (10%) experiencing hHF. The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83-1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes. Conclusions: In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models. Trial registration clinicaltrials.gov no. NCT00790205

Original languageEnglish (US)
Article number116
JournalCardiovascular Diabetology
Volume18
Issue number1
DOIs
StatePublished - Sep 3 2019

Fingerprint

Hospitalization
Heart Failure
Myocardial Infarction
Placebos
Type 2 Diabetes Mellitus
Cardiovascular Diseases
Intention to Treat Analysis
Sitagliptin Phosphate
Proportional Hazards Models
Animal Models
Therapeutics

Keywords

  • Acute myocardial infarction
  • Cardiovascular outcomes
  • Sitagliptin
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Cardiology and Cardiovascular Medicine

Cite this

Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes : Observations from TECOS. / Nauck, Michael A.; McGuire, Darren K; Pieper, Karen S.; Lokhnygina, Yuliya; Strandberg, Timo E.; Riefflin, Axel; Delibasi, Tuncay; Peterson, Eric D.; White, Harvey D.; Scott, Russell; Holman, Rury R.

In: Cardiovascular Diabetology, Vol. 18, No. 1, 116, 03.09.2019.

Research output: Contribution to journalArticle

Nauck, Michael A. ; McGuire, Darren K ; Pieper, Karen S. ; Lokhnygina, Yuliya ; Strandberg, Timo E. ; Riefflin, Axel ; Delibasi, Tuncay ; Peterson, Eric D. ; White, Harvey D. ; Scott, Russell ; Holman, Rury R. / Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes : Observations from TECOS. In: Cardiovascular Diabetology. 2019 ; Vol. 18, No. 1.
@article{dbd192d9186043c48643132ed4594ca5,
title = "Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes: Observations from TECOS",
abstract = "Background: To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Methods: TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses. Results: During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95{\%} CI 0.81-1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15{\%}) died subsequently, with 66 (11{\%}) being CV deaths, and 57 (10{\%}) experiencing hHF. The composite outcome occurred in 58 (20.1{\%}; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6{\%}; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95{\%} CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95{\%} CI 0.83-1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes. Conclusions: In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models. Trial registration clinicaltrials.gov no. NCT00790205",
keywords = "Acute myocardial infarction, Cardiovascular outcomes, Sitagliptin, Type 2 diabetes",
author = "Nauck, {Michael A.} and McGuire, {Darren K} and Pieper, {Karen S.} and Yuliya Lokhnygina and Strandberg, {Timo E.} and Axel Riefflin and Tuncay Delibasi and Peterson, {Eric D.} and White, {Harvey D.} and Russell Scott and Holman, {Rury R.}",
year = "2019",
month = "9",
day = "3",
doi = "10.1186/s12933-019-0921-2",
language = "English (US)",
volume = "18",
journal = "Cardiovascular Diabetology",
issn = "1475-2840",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Sitagliptin does not reduce the risk of cardiovascular death or hospitalization for heart failure following myocardial infarction in patients with diabetes

T2 - Observations from TECOS

AU - Nauck, Michael A.

AU - McGuire, Darren K

AU - Pieper, Karen S.

AU - Lokhnygina, Yuliya

AU - Strandberg, Timo E.

AU - Riefflin, Axel

AU - Delibasi, Tuncay

AU - Peterson, Eric D.

AU - White, Harvey D.

AU - Scott, Russell

AU - Holman, Rury R.

PY - 2019/9/3

Y1 - 2019/9/3

N2 - Background: To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Methods: TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses. Results: During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95% CI 0.81-1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15%) died subsequently, with 66 (11%) being CV deaths, and 57 (10%) experiencing hHF. The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83-1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes. Conclusions: In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models. Trial registration clinicaltrials.gov no. NCT00790205

AB - Background: To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Methods: TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses. Results: During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95% CI 0.81-1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15%) died subsequently, with 66 (11%) being CV deaths, and 57 (10%) experiencing hHF. The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83-1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83-1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes. Conclusions: In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models. Trial registration clinicaltrials.gov no. NCT00790205

KW - Acute myocardial infarction

KW - Cardiovascular outcomes

KW - Sitagliptin

KW - Type 2 diabetes

UR - http://www.scopus.com/inward/record.url?scp=85071775016&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85071775016&partnerID=8YFLogxK

U2 - 10.1186/s12933-019-0921-2

DO - 10.1186/s12933-019-0921-2

M3 - Article

C2 - 31481069

AN - SCOPUS:85071775016

VL - 18

JO - Cardiovascular Diabetology

JF - Cardiovascular Diabetology

SN - 1475-2840

IS - 1

M1 - 116

ER -