title: Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).
abstract: 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.
  
  
  
  Clinical and safety event summaries are presented for older versus younger participants and for the treatment groups within the older cohort.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K. angelyn.bethel@dtu.ox.ac.uk.
authors.forename: M Angelyn
authors.initials: MA
authors.lastname: Bethel
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Engel
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Green
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Huang
authors.affiliation: St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Josse
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Kaufman
authors.affiliation: Munich Diabetes Research Group e.V., Helmholtz Centre, Neuherberg, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Standl
authors.affiliation: Merck Research Laboratories, Merck & Co., Inc., Kenilworth, NJ.
authors.forename: Shailaja
authors.initials: S
authors.lastname: Suryawanshi
authors.affiliation: Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
authors.affiliation: Division of Cardiology, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX.
authors.forename: Darren K
authors.initials: DK
authors.lastname: McGuire
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, U.K.
authors.forename: Rury R
authors.initials: RR
authors.lastname: Holman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D012307:Risk Factors; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage*; D020521:Stroke / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000068900:Sitagliptin Phosphate