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Sitagliptin and risk of fractures in type 2 diabetes: R esults from the TECOS trial
Author(s) -
Josse Robert G.,
Majumdar Sumit R.,
Zheng Yinggan,
Adler Amanda,
Bethel M. Angelyn,
Buse John B.,
Green Jennifer B.,
Kaufman Keith D.,
Rodbard Helena W.,
Tankova Tsvetalina,
Westerhout Cynthia M.,
Peterson Eric D.,
Holman Rury R.,
Armstrong Paul W.
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12786
Subject(s) - medicine , hazard ratio , sitagliptin , placebo , confidence interval , type 2 diabetes , osteoporosis , incidence (geometry) , diabetes mellitus , hip fracture , blood pressure , glycated hemoglobin , gastroenterology , endocrinology , physics , alternative medicine , pathology , optics
Aim To examine fracture incidence among participants in the T rial E valuating C ardiovascular O utcomes with S itagliptin ( TECOS ). Research design and methods We used data from 14 671 participants in the TECOS study who were randomized double‐blind to sitagliptin (n = 7332) or placebo (n = 7339). Cumulative fracture incidence rates were calculated and their association with study treatment assignment was examined using multivariable C ox proportional hazards regression. Results The baseline mean (standard deviation) participant age was 65.5 (8.0) years, diabetes duration was 11.6 (8.1) years and glycated haemoglobin level was 7.2 (0.5)% [55.2 (5.5) mmol/mol], and 29.3% of participants were women and 32.1% were non‐white. During 43 222 person‐years’ follow‐up, 375 (2.6%; 8.7 per 1000 person‐years) had a fracture; 146 were major osteoporotic fractures (hip, n = 34; upper extremity, n = 81; and clinical spine, n = 31). Adjusted analyses showed fracture risk increased independently with older age ( P < .001), female sex ( P < .001), white race ( P < .001), lower diastolic blood pressure ( P < .001) and diabetic neuropathy ( P = .003). Sitagliptin, compared with placebo, was not associated with a higher fracture risk [189 vs 186 incident fractures: unadjusted hazard ratio ( HR ) 1.01, 95% confidence interval ( CI ) 0.82 to 1.23, P = .944; adjusted HR 1.03, P = .745], major osteoporotic fractures ( P = .673) or hip fractures ( P = .761). Insulin therapy was associated with a higher fracture risk ( HR 1.40, 95% CI 1.02‐1.91; P = .035), and metformin with a lower risk ( HR 0.76, 95% CI 0.59‐0.98; P = .035). Conclusion Fractures were common among people with diabetes in the TECOS study, but were not related to sitagliptin therapy. Insulin and metformin treatment were associated with higher and lower fracture risks, respectively.