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Assessing the Safety of Sitagliptin in Older Participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).
- Source :
- Diabetes Care; Apr2017, Vol. 40 Issue 4, p494-501, 8p, 4 Charts, 1 Graph
- Publication Year :
- 2017
-
Abstract
- <bold>Objective: </bold>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.<bold>Research Design and Methods: </bold>Clinical and safety event summaries are presented for older versus younger participants and for the treatment groups within the older cohort.<bold>Results: </bold>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.<bold>Conclusions: </bold>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. [ABSTRACT FROM AUTHOR]
- Subjects :
- SITAGLIPTIN
DRUG efficacy
TYPE 2 diabetes treatment
DIABETES in old age
HYPOGLYCEMIC agents
THERAPEUTICS
COMPARATIVE studies
GLYCOSYLATED hemoglobin
HYPOGLYCEMIA
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
MYOCARDIAL infarction
TYPE 2 diabetes
RESEARCH
STATISTICAL sampling
STROKE
EVALUATION research
BODY mass index
RANDOMIZED controlled trials
TREATMENT effectiveness
BLIND experiment
Subjects
Details
- Language :
- English
- ISSN :
- 01495992
- Volume :
- 40
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Diabetes Care
- Publication Type :
- Academic Journal
- Accession number :
- 122013030
- Full Text :
- https://doi.org/10.2337/dc16-1135