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Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).

Publication ,  Journal Article
Bethel, MA; Engel, SS; Green, JB; Huang, Z; Josse, RG; Kaufman, KD; Standl, E; Suryawanshi, S; Van de Werf, F; McGuire, DK; Peterson, ED ...
Published in: Diabetes Care
April 2017

OBJECTIVE: Limited data exist regarding safety and efficacy of antihyperglycemic drugs in older patients with type 2 diabetes. The Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) was a randomized, double-blind, placebo-controlled trial assessing the impact of sitagliptin on a primary composite outcome of cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, or unstable angina hospitalizations in patients with type 2 diabetes (HbA1c ≥6.5% [48 mmol/mol] and ≤8.0% [64 mmol/mol]) and cardiovascular disease. We analyzed baseline characteristics and clinical outcomes for TECOS participants aged ≥75 years. RESEARCH DESIGN AND METHODS: Clinical and safety event summaries are presented for older versus younger participants and for the treatment groups within the older cohort. RESULTS: Of 14,351 participants with age recorded, 2,004 (14%) were ≥75 years old (mean age 78.3 years [SD 3.1]), with 68% men and type 2 diabetes duration median 12.0 years (IQR 7, 21). During 2.9 years median follow-up, older participants had higher rates of the primary outcome (6.46 vs. 3.67 events per 100 person-years; hazard ratio 1.72 [95% CI 1.52-1.94]), death (2.52 [2.20-2.89]), severe hypoglycemia (1.53 [1.15-2.03]), and fractures (1.84 [1.44-2.35]). In the older cohort, sitagliptin did not significantly impact the primary composite (1.10 [0.89-1.36]), death (1.05 [0.83-1.32]), heart failure hospitalization (0.99 [0.65-1.49]), severe hypoglycemia (1.03 [0.62-1.71]), rates of acute pancreatitis and pancreatic cancer, or serious adverse events. CONCLUSIONS: Among older patients with well-controlled type 2 diabetes and cardiovascular disease, sitagliptin had neutral effects on cardiovascular risk and raised no significant safety concerns.

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Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

April 2017

Volume

40

Issue

4

Start / End Page

494 / 501

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Sitagliptin Phosphate
  • Risk Factors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Hypoglycemic Agents
  • Hypoglycemia
  • Humans
 

Citation

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Bethel, M. A., Engel, S. S., Green, J. B., Huang, Z., Josse, R. G., Kaufman, K. D., … TECOS Study Group, . (2017). Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Care, 40(4), 494–501. https://doi.org/10.2337/dc16-1135
Bethel, M Angelyn, Samuel S. Engel, Jennifer B. Green, Zhen Huang, Robert G. Josse, Keith D. Kaufman, Eberhard Standl, et al. “Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).Diabetes Care 40, no. 4 (April 2017): 494–501. https://doi.org/10.2337/dc16-1135.
Bethel MA, Engel SS, Green JB, Huang Z, Josse RG, Kaufman KD, et al. Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Care. 2017 Apr;40(4):494–501.
Bethel, M. Angelyn, et al. “Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).Diabetes Care, vol. 40, no. 4, Apr. 2017, pp. 494–501. Pubmed, doi:10.2337/dc16-1135.
Bethel MA, Engel SS, Green JB, Huang Z, Josse RG, Kaufman KD, Standl E, Suryawanshi S, Van de Werf F, McGuire DK, Peterson ED, Holman RR, TECOS Study Group. Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Care. 2017 Apr;40(4):494–501.

Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

April 2017

Volume

40

Issue

4

Start / End Page

494 / 501

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Sitagliptin Phosphate
  • Risk Factors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Hypoglycemic Agents
  • Hypoglycemia
  • Humans