| Summary: | <h4>Objective</h4> <p>To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i), according to baseline estimated glomerular filtration rate (eGFR).</p> <h4>Research Design and Methods</h4> <p>We used data from 14,671 TECOS participants assigned double-blind to receive sitagliptin or placebo added to existing therapy, whilst aiming for glycemic equipoise between groups. Cardiovascular and CKD outcomes were evaluated over median of 3 years, with participants categorized at baseline into eGFR stages 1, 2, 3a and 3b (≥90, 60-89, 45-59 or 30-44 ml/min/1.73m2, respectively).</p> <h4>Results</h4> <p>Participants with eGFR stage 3b were older, more often female and had longer diabetes duration. Four-point MACE rates increased with lower baseline eGFR (3.52, 3.55, 5.74 and 7.34 events per 100 patient-years for stages 1-3b, respectively. Corresponding adjusted hazard ratios (95% CI) for stages 2, 3a and 3b versus stage 1 were 0.93 (0.82–1.06), 1.28 (1.10–1.49) and 1.39 (1.13–1.72), respectively. Sitagliptin was not associated with cardiovascular outcomes for any eGFR stage (interaction P values all >0.44). Kidney function declined at the same rate in both treatment groups, with a marginally lower but constant eGFR difference (−1.3 ml/min/1.73m2) in those assigned to sitagliptin. Treatment differences in these eGFR values remained after adjustment for region, baseline eGFR, baseline HbA1c, time of assessment and within-study HbA1c levels.</p> <h4>Conclusions</h4> <p>Impaired kidney function is associated with worse cardiovascular outcomes. Sitagliptin has no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR. </p>
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