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Safety of sitagliptin in patients with type 2 diabetes and chronic kidney disease: outcomes from TECOS
Author(s) -
Engel Samuel S.,
Suryawanshi Shailaja,
Stevens Susanna R.,
Josse Robert G.,
Cornel Jan H.,
Jakuboniene Neli,
Riefflin Axel,
Tankova Tsvetalina,
Wainstein Julio,
Peterson Eric D.,
Holman Rury R.
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.12983
Subject(s) - medicine , sitagliptin , kidney disease , sitagliptin phosphate , diabetes mellitus , cohort , adverse effect , type 2 diabetes , population , surgery , endocrinology , environmental health
Aims To characterize the incidence of diabetes‐associated complications and assess the safety of sitagliptin in participants with chronic kidney disease ( CKD ) in the T rial E valuating C ardiovascular O utcomes with S itagliptin ( TECOS ). Materials and methods For participants with baseline eGFR measurements (n = 14 528), baseline characteristics and safety outcomes were compared for the CKD cohort ( eGFR < 60 mL/min per 1.73 m 2 ) vs those without CKD . Within the CKD cohort, the same analyses were performed, comparing sitagliptin‐ and placebo‐assigned participants. Baseline characteristics were summarized for all participants, and serious adverse events were analysed in those who received at least 1 dose of study medication. Adverse events of interest and diabetes complications were summarized for the intention‐to‐treat population. Results CKD was present in 3324 (23%) participants at entry into TECOS . The mean ( SD ) age for this CKD cohort was 68.8 (7.9) years, mean diabetes duration was 13.7 (9.0) years, and 62% were men. Incidences of serious adverse events, malignancy, bone fracture, severe hypoglycaemia and most categories of diabetes complications were higher in the CKD cohort compared with those without CKD . Over ~2.8 median years of follow‐up, CKD participants assigned to sitagliptin had rates of diabetic eye disease, diabetic neuropathy, renal failure, malignancy, bone fracture, pancreatitis and severe hypoglycaemia similar to those of placebo‐assigned participants. Conclusions Participants in TECOS with CKD had higher incidences of serious adverse events and diabetes complications than those without CKD . Treatment with sitagliptin was generally well tolerated, with no meaningful differences in safety outcomes observed between those with CKD assigned to sitagliptin or placebo.