Abstract
The incidence of heart failure hospitalization (HHF) after taking sitagliptin in type 2 diabetes (T2DM) patients with end stage renal disease (ESRD) on dialysis is unclear. In this population-based cohort study, we identified individuals with T2DM and ESRD on dialysis who were treated with sitagliptin between 2009 and 2011 and randomly selected a control cohort matched by age, sex, duration of T2DM, hypertension medications, use of statin and aspirin, sulfonylureas, glinides, and insulin usage, atherosclerotic heart disease, congestive heart failure and chronic obstructive pulmonary disease at a 1:4 ratio. Multivariable Cox proportional hazards regression analysis was used to evaluate HHF risk. The overall incidence of HHF was higher in the sitagliptin cohort than in the control cohort (1130 vs. 754 per 10000 person-years; adjusted hazard ratio (HR): 1.52, 95% CI = 1.21–1.90). There was a significant trend towards increased HHF risk associated with increased sitagliptin dose (p for trend < 0.01). Subjects at greater risk of HHF after taking sitagliptin were those without severe hypoglycemia, without ACE inhibitors treatment, with history of heart failure or receiving hemodialysis rather than peritoneal dialysis. In conclusion, use of sitagliptin was associated with an increased risk of HHF in patients with T2DM on dialysis.
Highlights
Taiwan has the highest prevalence and the third highest incidence of end stage renal disease (ESRD) in the world as of 20111
Our study showed that sitagliptin use was associated with an increased risk of hospitalization for heart failure (HHF) in patients with T2DM receiving dialysis, especially in those without severe hypoglycemia, without ACE inhibitors treatment, with prior heart failure (HF) or receiving hemodialysis
Based on FDA recommendations, Dipeptidyl peptidase-4 (DPP-4) inhibitors have been tested in large clinical outcome trials: The SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53)[5], the EXAMINE (Cardiovascular Outcomes Study of Alogliptin in Patients with Type 2 Diabetes and Acute Coronary Syndrome)[10] and the TECOS7 trials
Summary
Taiwan has the highest prevalence and the third highest incidence of end stage renal disease (ESRD) in the world as of 20111. A large-scale randomized trial among patients with T2DM who are at risk for CV events has shown that saxagliptin has a neutral effect in relation to CV events; its use was found to be associated with a higher incidence of hospitalization for heart failure (HHF)[5]. This increase in heart failure (HF) risk was highest among patients with elevated levels of N-terminal pro B-type natriuretic peptides (NT-proBNP), prior HF, or CKD6. We aim to evaluate the association of sitagliptin treatment with HHF in patients with T2DM and ESRD on dialysis
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