Effects of linagliptin on cardiovascular and kidney outcomes in people with normal and reduced kidney function: secondary analysis of the CARMELINA randomized trial
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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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Reductions in risk of albuminuria progression were noted with linagliptin in the CARMELINA trial.
“Reductions in risk of albuminuria progression were noted with linagliptin in the Cardiovascular and Renal Microvascular Outcome Study With Linagliptin (CARMELINA) trial (180).”
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- Authors
- Perkovic, V., Toto, R., Cooper, M. E., Mann, J. F. E., Rosenstock, J., McGuire, D. K., Kahn, S. E., Marx, N., Alexander, J. H., Zinman, B., Pfarr, E., Schnaidt, S., Meinicke, T., von Eynatten, M., George, J. T., Johansen, O. E., & Wanner, C.
- Affiliations
- UNSW Sydney (AU)
- The University of Texas Southwestern Medical Center (US)
- Monash University (AU)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- Dallas Diabetes Research Center (US)
- University of Washington (US)
- Universitätsklinikum Aachen (DE)
- Duke Clinical Research Institute (US)
- Mount Sinai Hospital (CA)
- Boehringer Ingelheim (Germany) (DE)
- Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
- Boehringer Ingelheim (Norway) (NO)
- Universitätsklinikum Würzburg (DE)
- Corresponding author
- Perkovic, Vlado
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2020-05-22
- Volume
- 43
- Issue
- 8
- Pages
- 1803-1812
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC7372065
- OpenAlex
- W3028183585
- Cited by
- 62
- References
- 47
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 6 · 2023: 10 · 2022: 15 · 2021: 15 · 2020: 3
- FWCI
- 8.11
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association
- American Society of Nephrology
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- AbbVie
- CSL Behring
- Intarcia Therapeutics
- Zafgen
- CryoLife
- Eisai
- Novo Nordisk
- Astellas Pharma
- Vifor Pharma
- Servier
- Esperion Therapeutics
- National Institutes of Health
- Genentech
- Medical Research Council
- National Health and Medical Research Council
- Relypsa
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
- Keywords
- linagliptin, type 2 diabetes, chronic kidney disease, DPP-4 inhibitors, cardiovascular outcomes, renal outcomes, albuminuria progression, estimated glomerular filtration rate, HbA1c, hypoglycemia, major adverse cardiovascular events, end-stage renal disease, cardiovascular disease
- MeSH terms
- Linagliptin, Aged, Cardiovascular Diseases, Cardiovascular System, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Female, Glomerular Filtration Rate, Humans, Hypoglycemic Agents, Kidney, Kidney Failure, Chronic, Male, Middle Aged, Mortality, Prognosis, Retrospective Studies, Incidence, Treatment Outcome, Renal Insufficiency, Chronic, Dipeptidyl-Peptidase IV Inhibitors
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