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Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS.

Publication ,  Journal Article
Cornel, JH; Bakris, GL; Stevens, SR; Alvarsson, M; Bax, WA; Chuang, L-M; Engel, SS; Lopes, RD; McGuire, DK; Riefflin, A; Rodbard, HW; Sinay, I ...
Published in: Diabetes Care
December 2016

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 from 14,671 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 increased with lower baseline eGFR (3.52, 3.55, 5.74, and 7.34 events/100 patient-years 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 (-1.3 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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Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

December 2016

Volume

39

Issue

12

Start / End Page

2304 / 2310

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sitagliptin Phosphate
  • Renal Insufficiency, Chronic
  • Middle Aged
  • Male
  • Kidney
  • Hypoglycemic Agents
  • Humans
  • Glomerular Filtration Rate
  • Female
 

Citation

APA
Chicago
ICMJE
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Cornel, J. H., Bakris, G. L., Stevens, S. R., Alvarsson, M., Bax, W. A., Chuang, L.-M., … TECOS Study Group, . (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
Cornel, Jan H., George L. Bakris, Susanna R. Stevens, Michael Alvarsson, Willem A. Bax, Lee-Ming Chuang, Samuel S. Engel, et al. “Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS.Diabetes Care 39, no. 12 (December 2016): 2304–10. https://doi.org/10.2337/dc16-1415.
Cornel JH, Bakris GL, Stevens SR, Alvarsson M, Bax WA, Chuang L-M, et al. Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS. Diabetes Care. 2016 Dec;39(12):2304–10.
Cornel, Jan H., et al. “Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS.Diabetes Care, vol. 39, no. 12, Dec. 2016, pp. 2304–10. Pubmed, doi:10.2337/dc16-1415.
Cornel JH, Bakris GL, Stevens SR, Alvarsson M, Bax WA, Chuang L-M, Engel SS, Lopes RD, McGuire DK, Riefflin A, Rodbard HW, Sinay I, Tankova T, Wainstein J, Peterson ED, Holman RR, TECOS Study Group. Effect of Sitagliptin on Kidney Function and Respective Cardiovascular Outcomes in Type 2 Diabetes: Outcomes From TECOS. Diabetes Care. 2016 Dec;39(12):2304–2310.

Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

December 2016

Volume

39

Issue

12

Start / End Page

2304 / 2310

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sitagliptin Phosphate
  • Renal Insufficiency, Chronic
  • Middle Aged
  • Male
  • Kidney
  • Hypoglycemic Agents
  • Humans
  • Glomerular Filtration Rate
  • Female