Linagliptin effects on heart failure and related outcomes in individuals with type 2 diabetes mellitus at high cardiovascular and renal risk in CARMELINA

McGuire, Darren K.; Alexander, John H.; Johansen, Odd Erik; Perkovic, Vlado; Rosenstock, Julio; Cooper, Mark E.; Wanner, Christoph; Kahn, Steven E.; Toto, Robert D.; Zinman, Bernard; Baanstra, David; Pfarr, Egon; Schnaidt, Sven; Meinicke, Thomas; George, Jyothis T.; von Eynatten, Maximilian; Marx, Nikolaus; On behalf of the CARMELINA Investigators

doi:10.1161/circulationaha.118.038352

Cited by 164Diabetes Treatment and ManagementHeart Failure Treatment and ManagementCardiovascular Function and Risk Factors

Linagliptin effects on heart failure and related outcomes in individuals with type 2 diabetes mellitus at high cardiovascular and renal risk in CARMELINA

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McGuire, Darren K., Alexander, John H., Johansen, Odd Erik, Perkovic, Vlado, Rosenstock, Julio, Cooper, Mark E., Wanner, Christoph, Kahn, Steven E. +10 more·2019·Circulation

DOI 10.1161/circulationaha.118.038352

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Abstract

Background: Individuals with type 2 diabetes mellitus are at increased risk for heart failure (HF), particularly those with coexisting atherosclerotic cardiovascular disease and/or kidney disease. Some but not all dipeptidyl peptidase-4 inhibitors have been associated with increased HF risk. We performed secondary analyses of HF and related outcomes with the dipeptidyl peptidase-4 inhibitor linagliptin versus placebo in CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin), a cardiovascular outcomes trial that enrolled participants with type 2 diabetes mellitus and atherosclerotic cardiovascular disease and/or kidney disease. Methods: Participants in 27 countries with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease were randomized 1:1 to receive once daily oral linagliptin 5 mg or placebo, on top of standard of care. All hospitalization for HF (hHF), cardiovascular outcomes, and deaths were prospectively captured and centrally adjudicated. In prespecified and post hoc analyses of HF and related events, Cox proportional hazards models adjusting for region and baseline history of HF were used. Recurrent hHF events were analyzed using a negative binomial model. In a subset of participants with left ventricular ejection fraction captured within the year before randomization, HF-related outcomes were assessed in subgroups stratified by left ventricular ejection fraction > or ≤50%. Results: CARMELINA enrolled 6979 participants (mean age, 65.9 years; estimated glomerular filtration rate, mL/min per 1.73m 2 ; hemoglobin A1c, 8.0%; 62.9% men; diabetes mellitus duration, 14.8 years), including 1873 (26.8%) with a history of HF at baseline. Median follow-up was 2.2 years. Linagliptin versus placebo did not affect the incidence of hHF (209/3494 [6.0%] versus 226/3485 [6.5%], respectively; hazard ratio [HR], 0.90; 95% CI, 0.74–1.08), the composite of cardiovascular death/hHF (HR, 0.94; 95% CI, 0.82–1.08), or risk for recurrent hHF events (326 versus 359 events, respectively; rate ratio, 0.94; 95% CI, 0.75–1.20). There was no heterogeneity of linagliptin effects on hHF by history of HF at baseline, baseline estimated glomerular filtration rate or urine albumin-creatinine ratio, or prerandomization left ventricular ejection fraction. Conclusions: In a large, international cardiovascular outcome trial in participants with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease, linagliptin did not affect the risk of hHF or other selected HF-related outcomes, including among participants with and without a history of HF, across the spectrum of kidney disease, and independent of previous left ventricular ejection fraction. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01897532.

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In the TECOS and CARMELINA trials, there was no increased risk of heart failure with either sitagliptin or linagliptin compared with placebo.
“These observations led to the development and regulatory filing of prospective HF analysis plans for the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) and CARMELINA (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus) trials, each of which revealed no increased risk of HF with either sitagliptin or linagliptin”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [179]
Sitagliptin and linagliptin have a neutral effect on heart failure hospitalization.
“Sitagliptin and linagliptin had a neutral effect.174,[178][179][180]”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [179]
In the CARMELINA trial, linagliptin did not increase the risk of heart failure hospitalization versus placebo.
“In addition, data from the CAROLINA trial comparing linagliptin (shown to not increase the risk of HF hospitalization vs. placebo in the CARMELINA trial) vs. glimepiride did not show an elevated risk of HF hospitalization by this sulphonylurea.179”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [179]
In the CAROLINA trial, glimepiride did not show an elevated risk of heart failure hospitalization.
“In addition, data from the CAROLINA trial comparing linagliptin (shown to not increase the risk of HF hospitalization vs. placebo in the CARMELINA trial) vs. glimepiride did not show an elevated risk of HF hospitalization by this sulphonylurea.179”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [179]
Subsequent observational studies, cardiovascular outcomes trials, and meta-analyses have not shown an excess heart failure risk with DPP4 inhibitors.
“Subsequent observational studies, CVOTs, and meta-analyses have not shown an excess heart failure risk with DPP4 inhibitors.”
From Clinical management of stable coronary artery disease in patients with type 2 diabetes mellitus: a scientific statement from the American Heart Association (2020) · cites this paper as [218]

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Authors: McGuire, D. K., Alexander, J. H., Johansen, O. E., Perkovic, V., Rosenstock, J., Cooper, M. E., Wanner, C., Kahn, S. E., Toto, R. D., Zinman, B., Baanstra, D., Pfarr, E., Schnaidt, S., Meinicke, T., George, J. T., von Eynatten, M., Marx, N., & On behalf of the CARMELINA Investigators
Affiliations: The University of Texas Southwestern Medical Center (US)
Duke University (US)
Boehringer Ingelheim (Norway) (NO)
UNSW Sydney (AU)
Dallas Diabetes Research Center (US)
Monash University (AU)
Universitätsklinikum Würzburg (DE)
University of Washington (US)
Mount Sinai Hospital (CA)
Boehringer Ingelheim (Netherlands) (NL)
Boehringer Ingelheim (Germany) (DE)
Boehringer Ingelheim International, Ingelheim, Germany (J.T.G., M.v.E.).
Universitätsklinikum Aachen (DE)
Corresponding author: McGuire, Darren K.
ORCID: McGuire, Darren K.
Alexander, John H.
Johansen, Odd Erik
Perkovic, Vlado
Rosenstock, Julio
Cooper, Mark E.
Wanner, Christoph
Kahn, Steven E.
Toto, Robert D.
Zinman, Bernard
George, Jyothis T.
Marx, Nikolaus
Venue: Circulation
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2019-01-15
Volume: 139
Issue: 3
Pages: 351-361
ISSN: 0009-7322 (ISSN-L)
1524-4539
DOI: 10.1161/circulationaha.118.038352
OpenAlex: W2900102850
Cited by: 164
References: 22
Citations by year: 2026: 7 · 2025: 10 · 2024: 9 · 2023: 10 · 2022: 17 · 2021: 22 · 2020: 51 · 2019: 37 · 2018: 1
FWCI: 25.77
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Circulation (publishedVersion)
PubMed (publishedVersion)
SZTE Publicatio Repozitórium (University of Szeged) (acceptedVersion, other-oa)
University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
Keywords: linagliptin, heart failure, type 2 diabetes, DPP-4 inhibitors, atherosclerotic cardiovascular disease, kidney disease, cardiovascular outcomes, heart failure hospitalization, left ventricular ejection fraction, cardiovascular mortality, heart failure recurrence, renal outcomes, cardiovascular risk stratification
MeSH terms: Linagliptin, Aged, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Glomerular Filtration Rate, Heart Failure, Glycated Hemoglobin, Humans, Kidney, Kidney Diseases, Male, Middle Aged, Prospective Studies, Risk Factors, Time Factors, Biomarkers, Prevalence, Treatment Outcome, Risk Assessment, Atherosclerosis, Dipeptidyl-Peptidase IV Inhibitors

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Linagliptin effects on heart failure and related outcomes in individuals with type 2 diabetes mellitus at high cardiovascular and renal risk in CARMELINA

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