Diabetes, obesity & metabolism 2017 04 22() doi 10.1111/dom.12983
To characterize the incidence of diabetes-associated complications and assess the safety of sitagliptin in participants with chronic kidney disease (CKD) in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (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) ) versus 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 analyzed in those who received at least one 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 hypoglycemia and most categories of diabetes complications were higher in the CKD cohort compared with those without CKD. Over ~2.8 median years’ follow-up, CKD participants assigned to sitagliptin had similar rates of diabetic eye disease, diabetic neuropathy, renal failure, malignancy, bone fracture, pancreatitis and severe hypoglycemia as placebo-assigned participants.
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 observed in safety outcomes between those with CKD assigned sitagliptin or placebo.