TY - JOUR
T1 - Effect of sitagliptin on kidney function and respective cardiovascular outcomes in type 2 diabetes
T2 - Outcomes from TECOS
AU - Cornel, Jan H.
AU - Bakris, George L.
AU - Stevens, Susanna R.
AU - Alvarsson, Michael
AU - Bax, Willem A.
AU - Chuang, Lee Ming
AU - Engel, Samuel S.
AU - Lopes, Renato D.
AU - McGuire, Darren K.
AU - Riefflin, Axel
AU - Rodbard, Helena Wachslicht
AU - Sinay, Isaac
AU - Tankova, Tsvetalina
AU - Wainstein, Julio
AU - Peterson, Eric D.
AU - Holman, Rury R.
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85006117462&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85006117462&partnerID=8YFLogxK
U2 - 10.2337/dc16-1415
DO - 10.2337/dc16-1415
M3 - Article
C2 - 27742728
AN - SCOPUS:85006117462
SN - 0149-5992
VL - 39
SP - 2304
EP - 2310
JO - Diabetes care
JF - Diabetes care
IS - 12
ER -