Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes: Outcomes from TECOS

Jan H. Cornel, George L. Bakris, Susanna R. Stevens, Michael Alvarsson, Willem A. Bax, Lee Ming Chuang, Samuel S. Engel, Renato D. Lopes, Darren K. McGuire, Axel Riefflin, Helena Wachslicht Rodbard, Isaac Sinay, Tsvetalina Tankova, Julio Wainstein, Eric D. Peterson, Rury R. Holman

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS (Clinical trial reg. no. NCT00790205, clinicaltrials.gov) participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase 4 inhibitor, according to baseline estimated glomerular filtration rate (eGFR). RESEARCH DESIGN AND METHODS We used data from14,671 TECOS participants assigned in a double-blind design to receive sitagliptin or placebo added to existing therapy, while aiming for glycemic equipoise between groups. Cardiovascular and CKD outcomes were evaluated over a median period of 3 years, with participants categorized at baseline into eGFR stages 1, 2, 3a, and 3b (≥90, 60-89, 45-59, or 30-44 mL/min/1.73 m2, respectively). RESULTS Participants with eGFR stage 3b were older, were more often female, and had a longer duration of diabetes. Four-point major adverse cardiovascular event rates increasedwith lower baseline eGFR (3.52, 3.55, 5.74, and 7.34 events/100 patientyears for stages 1-3b, respectively). Corresponding adjusted hazard ratios for stages 2, 3a, and 3b versus stage 1 were 0.93 (95% CI 0.82-1.06), 1.28 (1.10-1.49), and 1.39 (1.13-1.72), respectively. Sitagliptin therapy was not associated with cardiovascular outcomes for any eGFR stage (interaction P values were all >0.44). Kidney function declined at the same rate in both treatment groups, with a marginally lower but constant eGFR difference (21.3 mL/min/1.73 m2) in those participants who were assigned to sitagliptin. Treatment differences in these eGFR values remained after adjustment for region, baseline eGFR, baseline HbA1c, time of assessment, and within-study HbA1c levels. CONCLUSIONS Impaired kidney function is associated with worse cardiovascular outcomes. Sitagliptin has no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR.

Original languageEnglish (US)
Pages (from-to)2304-2310
Number of pages7
JournalDiabetes Care
Volume39
Issue number12
DOIs
StatePublished - 2016

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Glomerular Filtration Rate
Type 2 Diabetes Mellitus
Kidney
Chronic Renal Insufficiency
Dipeptidyl-Peptidase IV Inhibitors
Sitagliptin Phosphate
Therapeutics
Research Design
Cardiovascular Diseases
Placebos
Clinical Trials

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Cornel, J. H., Bakris, G. L., Stevens, S. R., Alvarsson, M., Bax, W. A., Chuang, L. M., ... Holman, R. R. (2016). Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes: Outcomes from TECOS. Diabetes Care, 39(12), 2304-2310. https://doi.org/10.2337/dc16-1415

Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes : Outcomes from TECOS. / Cornel, Jan H.; Bakris, George L.; Stevens, Susanna R.; Alvarsson, Michael; Bax, Willem A.; Chuang, Lee Ming; Engel, Samuel S.; Lopes, Renato D.; McGuire, Darren K.; Riefflin, Axel; Rodbard, Helena Wachslicht; Sinay, Isaac; Tankova, Tsvetalina; Wainstein, Julio; Peterson, Eric D.; Holman, Rury R.

In: Diabetes Care, Vol. 39, No. 12, 2016, p. 2304-2310.

Research output: Contribution to journalArticle

Cornel, JH, Bakris, GL, Stevens, SR, Alvarsson, M, Bax, WA, Chuang, LM, Engel, SS, Lopes, RD, McGuire, DK, Riefflin, A, Rodbard, HW, Sinay, I, Tankova, T, Wainstein, J, Peterson, ED & Holman, RR 2016, 'Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes: Outcomes from TECOS', Diabetes Care, vol. 39, no. 12, pp. 2304-2310. https://doi.org/10.2337/dc16-1415
Cornel, Jan H. ; Bakris, George L. ; Stevens, Susanna R. ; Alvarsson, Michael ; Bax, Willem A. ; Chuang, Lee Ming ; Engel, Samuel S. ; Lopes, Renato D. ; McGuire, Darren K. ; Riefflin, Axel ; Rodbard, Helena Wachslicht ; Sinay, Isaac ; Tankova, Tsvetalina ; Wainstein, Julio ; Peterson, Eric D. ; Holman, Rury R. / Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes : Outcomes from TECOS. In: Diabetes Care. 2016 ; Vol. 39, No. 12. pp. 2304-2310.
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abstract = "OBJECTIVE To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS (Clinical trial reg. no. NCT00790205, clinicaltrials.gov) participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase 4 inhibitor, according to baseline estimated glomerular filtration rate (eGFR). RESEARCH DESIGN AND METHODS We used data from14,671 TECOS participants assigned in a double-blind design to receive sitagliptin or placebo added to existing therapy, while aiming for glycemic equipoise between groups. Cardiovascular and CKD outcomes were evaluated over a median period of 3 years, with participants categorized at baseline into eGFR stages 1, 2, 3a, and 3b (≥90, 60-89, 45-59, or 30-44 mL/min/1.73 m2, respectively). RESULTS Participants with eGFR stage 3b were older, were more often female, and had a longer duration of diabetes. Four-point major adverse cardiovascular event rates increasedwith lower baseline eGFR (3.52, 3.55, 5.74, and 7.34 events/100 patientyears for stages 1-3b, respectively). Corresponding adjusted hazard ratios for stages 2, 3a, and 3b versus stage 1 were 0.93 (95{\%} CI 0.82-1.06), 1.28 (1.10-1.49), and 1.39 (1.13-1.72), respectively. Sitagliptin therapy was not associated with cardiovascular outcomes for any eGFR stage (interaction P values were all >0.44). Kidney function declined at the same rate in both treatment groups, with a marginally lower but constant eGFR difference (21.3 mL/min/1.73 m2) in those participants who were assigned to sitagliptin. Treatment differences in these eGFR values remained after adjustment for region, baseline eGFR, baseline HbA1c, time of assessment, and within-study HbA1c levels. CONCLUSIONS Impaired kidney function is associated with worse cardiovascular outcomes. Sitagliptin has no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR.",
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T1 - Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes

T2 - Outcomes from TECOS

AU - Cornel, Jan H.

AU - Bakris, George L.

AU - Stevens, Susanna R.

AU - Alvarsson, Michael

AU - Bax, Willem A.

AU - Chuang, Lee Ming

AU - Engel, Samuel S.

AU - Lopes, Renato D.

AU - McGuire, Darren K.

AU - Riefflin, Axel

AU - Rodbard, Helena Wachslicht

AU - Sinay, Isaac

AU - Tankova, Tsvetalina

AU - Wainstein, Julio

AU - Peterson, Eric D.

AU - Holman, Rury R.

PY - 2016

Y1 - 2016

N2 - OBJECTIVE To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS (Clinical trial reg. no. NCT00790205, clinicaltrials.gov) participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase 4 inhibitor, according to baseline estimated glomerular filtration rate (eGFR). RESEARCH DESIGN AND METHODS We used data from14,671 TECOS participants assigned in a double-blind design to receive sitagliptin or placebo added to existing therapy, while aiming for glycemic equipoise between groups. Cardiovascular and CKD outcomes were evaluated over a median period of 3 years, with participants categorized at baseline into eGFR stages 1, 2, 3a, and 3b (≥90, 60-89, 45-59, or 30-44 mL/min/1.73 m2, respectively). RESULTS Participants with eGFR stage 3b were older, were more often female, and had a longer duration of diabetes. Four-point major adverse cardiovascular event rates increasedwith lower baseline eGFR (3.52, 3.55, 5.74, and 7.34 events/100 patientyears for stages 1-3b, respectively). Corresponding adjusted hazard ratios for stages 2, 3a, and 3b versus stage 1 were 0.93 (95% CI 0.82-1.06), 1.28 (1.10-1.49), and 1.39 (1.13-1.72), respectively. Sitagliptin therapy was not associated with cardiovascular outcomes for any eGFR stage (interaction P values were all >0.44). Kidney function declined at the same rate in both treatment groups, with a marginally lower but constant eGFR difference (21.3 mL/min/1.73 m2) in those participants who were assigned to sitagliptin. Treatment differences in these eGFR values remained after adjustment for region, baseline eGFR, baseline HbA1c, time of assessment, and within-study HbA1c levels. CONCLUSIONS Impaired kidney function is associated with worse cardiovascular outcomes. Sitagliptin has no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR.

AB - OBJECTIVE To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS (Clinical trial reg. no. NCT00790205, clinicaltrials.gov) participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase 4 inhibitor, according to baseline estimated glomerular filtration rate (eGFR). RESEARCH DESIGN AND METHODS We used data from14,671 TECOS participants assigned in a double-blind design to receive sitagliptin or placebo added to existing therapy, while aiming for glycemic equipoise between groups. Cardiovascular and CKD outcomes were evaluated over a median period of 3 years, with participants categorized at baseline into eGFR stages 1, 2, 3a, and 3b (≥90, 60-89, 45-59, or 30-44 mL/min/1.73 m2, respectively). RESULTS Participants with eGFR stage 3b were older, were more often female, and had a longer duration of diabetes. Four-point major adverse cardiovascular event rates increasedwith lower baseline eGFR (3.52, 3.55, 5.74, and 7.34 events/100 patientyears for stages 1-3b, respectively). Corresponding adjusted hazard ratios for stages 2, 3a, and 3b versus stage 1 were 0.93 (95% CI 0.82-1.06), 1.28 (1.10-1.49), and 1.39 (1.13-1.72), respectively. Sitagliptin therapy was not associated with cardiovascular outcomes for any eGFR stage (interaction P values were all >0.44). Kidney function declined at the same rate in both treatment groups, with a marginally lower but constant eGFR difference (21.3 mL/min/1.73 m2) in those participants who were assigned to sitagliptin. Treatment differences in these eGFR values remained after adjustment for region, baseline eGFR, baseline HbA1c, time of assessment, and within-study HbA1c levels. CONCLUSIONS Impaired kidney function is associated with worse cardiovascular outcomes. Sitagliptin has no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR.

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