Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes: Outcomes from TECOS
Journal
Diabetes Care
Journal Volume
39
Journal Issue
12
Pages
2304-2310
Date Issued
2016
Author(s)
Cornel J.H.
Bakris G.L.
Stevens S.R.
Alvarsson M.
Bax W.A.
Engel S.S.
Lopes R.D.
McGuire D.K.
Riefflin A.
Rodbard H.W.
Sinay I.
Tankova T.
Wainstein J.
Peterson E.D.
Holman R.R.
Abstract
OBJECTIVE To evaluate chronic kidney disease (CKD) and cardiovascular outcomes in TECOS (Clinical trial reg. no. NCT00790205, clinicaltrials.gov) participants with type 2 diabetes and cardiovascular disease treated with sitagliptin, a dipeptidyl peptidase 4 inhibitor, according to baseline estimated glomerular filtration rate (eGFR). RESEARCH DESIGN AND METHODS We used data from14,671 TECOS participants assigned in a double-blind design to receive sitagliptin or placebo added to existing therapy, while aiming for glycemic equipoise between groups. Cardiovascular and CKD outcomes were evaluated over a median period 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/1.73 m2, respectively). RESULTS Participants with eGFR stage 3b were older, were more often female, and had a longer duration of diabetes. Four-point major adverse cardiovascular event rates increasedwith lower baseline eGFR (3.52, 3.55, 5.74, and 7.34 events/100 patientyears for stages 1-3b, respectively). Corresponding adjusted hazard ratios for stages 2, 3a, and 3b versus stage 1 were 0.93 (95% CI 0.82-1.06), 1.28 (1.10-1.49), and 1.39 (1.13-1.72), respectively. Sitagliptin therapy was not associated with cardiovascular outcomes for any eGFR stage (interaction P values were all >0.44). Kidney function declined at the same rate in both treatment groups, with a marginally lower but constant eGFR difference (21.3 mL/min/1.73 m2) in those participants who were 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. CONCLUSIONS Impaired kidney function is associated with worse cardiovascular outcomes. Sitagliptin has no clinically significant impact on cardiovascular or CKD outcomes, irrespective of baseline eGFR.
SDGs
Other Subjects
hemoglobin A1c; placebo; sitagliptin; antidiabetic agent; dipeptidyl peptidase IV inhibitor; sitagliptin; adult; age; albuminuria; cardiovascular function; chronic kidney failure; Conference Paper; controlled study; creatinine clearance; disease classification; disease duration; double blind procedure; drug effect; female; gender; glomerulus filtration rate; glycemic control; hemoglobin blood level; human; kidney function; major clinical study; male; non insulin dependent diabetes mellitus; outcome assessment; randomized controlled trial; aged; Cardiovascular Diseases; clinical trial; complication; Diabetes Mellitus, Type 2; drug effects; kidney; middle aged; multicenter study; pathophysiology; Renal Insufficiency, Chronic; treatment outcome; Aged; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Double-Blind Method; Female; Glomerular Filtration Rate; Humans; Hypoglycemic Agents; Kidney; Male; Middle Aged; Renal Insufficiency, Chronic; Sitagliptin Phosphate; Treatment Outcome
Publisher
American Diabetes Association Inc.
Type
conference paper