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Author Notes:

Guillermo E. Umpierrez, MD, CDE, Department of Medicine, Emory University, School of Medicine, 69 Jesse Hill Jr Drive, Atlanta, GA 30303, USA. geumpie@emory.edu

GEU is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. GEU wrote the initial research proposal. SC, KT, SJ, BA and FJP conducted the study. SC, KT, FJP and GEU wrote the first draft of the manuscript. ALM, GMD, MF, RJG, PV, SJ, MH, MAU, RAG, WBK and SM reviewed/edited the research proposal and manuscript and contributed to the discussion. LP generated the random allocation sequence and conducted the statistical analysis.

Cardio-Thoracic Study Team collaborators: Omar Lattouf, Bradley G. Leshnower, Jeffrey Miller, John D. Vega, Katherine Carssow, N. Renee Cook, Michele Fielding and Sonya Mathewson. Partial data from this trial were presented at the American Diabetes Association meeting in June 2019. This investigator-initiated study was supported by a clinical research grant from Merck Inc. who also provided sitagliptin and placebo medications. The supporters of the study were not involved in the study design, data collection, analysis or interpretation of the results, or preparation of the manuscript.

Subject:

Research Funding:

GEU is partly supported by research grants from the NIH/NATS UL1 TR002378 from the Clinical and Translational Science Award programme, and 1P30DK111024–01 from NIH and National Centre for Research Resources. FJP, GMD and PV are supported by NIH grants: 1K23GM128221–01A1, 1K23DK122199–01A1 and 3K12HD085850–03S1. RJG is partially supported by research grants from NIH/NIDDK P30DK11102 and 1K23DK123384–01. GEU has also received unrestricted research support for research studies (to Emory University) from Merck, Novo Nordisk and Dexcom Inc. FJP received consulting fees from Merck, Boehringer Ingelheim, Lilly, AstraZeneca and Sanofi, and research support from Merck and Dexcom Inc. PV has received consulting fees from Merck and Boehringer Ingelheim. RJG has received unrestricted research support for studies (to Emory University) from Novo Nordisk and consulting fees from Abbott Diabetes Care, Sanofi, Valeritas, Eli Lilly and Novo Nordisk. No other potential conflict of interest relevant to this article was reported. SC, KT, SJ, MF, MH, LP, RAG, BA, ALM, WBK and SM declare no conflicts of interest.

This investigator-initiated study was supported by a clinical research grant from Merck Inc. who also provided sitagliptin and placebo medications.

Keywords:

  • cardiac surgery
  • CABG
  • DPP-4 inhibitors
  • hyperglycaemia
  • stress

Sitagliptin for the prevention and treatment of perioperative hyperglycaemia in patients with type 2 diabetes undergoing cardiac surgery: A randomized controlled trial

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Journal Title:

Diabetes, Obesity and Metabolism

Volume:

Volume 23, Number 2

Publisher:

, Pages 480-488

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Aim: To assess whether treatment with sitagliptin, starting before surgery and continued during the hospital stay, can prevent and reduce the severity of perioperative hyperglycaemia in patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery. Materials and Methods: We conducted a double-blinded, placebo-controlled trial in adults with type 2 diabetes randomly assigned to receive sitagliptin or matching placebo starting 1 day prior to surgery and continued during the hospital stay. The primary outcome was difference in the proportion of patients with postoperative hyperglycaemia (blood glucose [BG] > 10 mmol/L [>180 mg/dL]) in the intensive care unit (ICU). Secondary endpoints included differences in mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay and need of insulin therapy. Results: We included 182 participants randomized to receive sitagliptin or placebo (91 per group, age 64 ± 9 years, HbA1c 7.6% ± 1.5% and diabetes duration 10 ± 9 years). There were no differences in the number of patients with postoperative BG greater than 10 mmol/L, mean daily BG in the ICU or after transition to regular wards, hypoglycaemia, hospital complications or length of stay. There were no differences in insulin requirements in the ICU; however, sitagliptin therapy was associated with lower mean daily insulin requirements (21.1 ± 18.4 vs. 32.5 ± 26.3 units, P = .007) after transition to a regular ward compared with placebo. Conclusion: The administration of sitagliptin prior to surgery and during the hospital stay did not prevent perioperative hyperglycaemia or complications after CABG. Sitagliptin therapy was associated with lower mean daily insulin requirements after transition to regular wards.
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