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Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial.

Publication ,  Journal Article
Perkovic, V; Toto, R; Cooper, ME; Mann, JFE; Rosenstock, J; McGuire, DK; Kahn, SE; Marx, N; Alexander, JH; Zinman, B; Pfarr, E; Schnaidt, S ...
Published in: Diabetes Care
August 2020

OBJECTIVE: Type 2 diabetes is a leading cause of kidney failure, but few outcome trials proactively enrolled individuals with chronic kidney disease (CKD). We performed secondary analyses of cardiovascular (CV) and kidney outcomes across baseline estimated glomerular filtration rate (eGFR) categories (≥60, 45 to <60, 30 to <45, and <30 mL/min/1.73 m2) in Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA), a cardiorenal placebo-controlled outcome trial of the dipeptidyl peptidase 4 inhibitor linagliptin (NCT01897532). RESEARCH DESIGN AND METHODS: Participants with CV disease and/or CKD were included. The primary outcome was time to first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke (three-point major adverse CV event [3P-MACE]), with a secondary outcome of renal death, end-stage kidney disease, or sustained ≥40% decrease in eGFR from baseline. Other end points included progression of albuminuria, change in HbA1c, and adverse events (AEs) including hypoglycemia. RESULTS: A total of 6,979 subjects (mean age 65.9 years; eGFR 54.6 mL/min/1.73 m2; 80.1% albuminuria) were followed for 2.2 years. Across eGFR categories, linagliptin as compared with placebo did not affect the risk for 3P-MACE (hazard ratio 1.02 [95% CI 0.89, 1.17]) or the secondary kidney outcome (1.04 [0.89, 1.22]) (interaction P values >0.05). Regardless of eGFR, albuminuria progression was reduced with linagliptin, as was HbA1c, without increasing risk for hypoglycemia. AEs were balanced among groups overall and across eGFR categories. CONCLUSIONS: Across all GFR categories, in participants with type 2 diabetes and CKD and/or CV disease, there was no difference in risk for linagliptin versus placebo on CV and kidney events. Significant reductions in risk for albuminuria progression and HbA1c and no difference in AEs were observed.

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Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

August 2020

Volume

43

Issue

8

Start / End Page

1803 / 1812

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Retrospective Studies
  • Renal Insufficiency, Chronic
  • Prognosis
  • Mortality
  • Middle Aged
  • Male
  • Linagliptin
  • Kidney Failure, Chronic
  • Kidney
 

Citation

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Perkovic, V., Toto, R., Cooper, M. E., Mann, J. F. E., Rosenstock, J., McGuire, D. K., … CARMELINA investigators, . (2020). Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial. Diabetes Care, 43(8), 1803–1812. https://doi.org/10.2337/dc20-0279
Perkovic, Vlado, Robert Toto, Mark E. Cooper, Johannes F. E. Mann, Julio Rosenstock, Darren K. McGuire, Steven E. Kahn, et al. “Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial.Diabetes Care 43, no. 8 (August 2020): 1803–12. https://doi.org/10.2337/dc20-0279.
Perkovic V, Toto R, Cooper ME, Mann JFE, Rosenstock J, McGuire DK, et al. Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial. Diabetes Care. 2020 Aug;43(8):1803–12.
Perkovic, Vlado, et al. “Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial.Diabetes Care, vol. 43, no. 8, Aug. 2020, pp. 1803–12. Pubmed, doi:10.2337/dc20-0279.
Perkovic V, Toto R, Cooper ME, Mann JFE, Rosenstock J, McGuire DK, Kahn SE, Marx N, Alexander JH, Zinman B, Pfarr E, Schnaidt S, Meinicke T, von Eynatten M, George JT, Johansen OE, Wanner C, CARMELINA investigators. Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial. Diabetes Care. 2020 Aug;43(8):1803–1812.

Published In

Diabetes Care

DOI

EISSN

1935-5548

Publication Date

August 2020

Volume

43

Issue

8

Start / End Page

1803 / 1812

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Retrospective Studies
  • Renal Insufficiency, Chronic
  • Prognosis
  • Mortality
  • Middle Aged
  • Male
  • Linagliptin
  • Kidney Failure, Chronic
  • Kidney