Prevalent and incident heart failure in cardiovascular outcome trials of patients with type 2 diabetes.
Open accessAbstract
Despite multiple examples of glucose-lowering therapies affecting heart failure (HF) risk, ascertainment of HF data in cardiovascular outcome trials of these medications has not been systematically characterized. In this review, large (n >1,000) published phase III and IV cardiovascular outcome trials evaluating glucose-lowering therapies through June 2017 were identified. Data were abstracted from publications, U.S. Food and Drug Administration advisory committee records, and U.S. Food and Drug Administration labeling documents. Overall, 21 trials including 152,737 patients were evaluated. Rates and definitions of baseline HF and incident HF were inconsistently provided. Baseline ejection fraction data were provided in 3 studies but not specific to patients with HF. No trial reported functional class, ejection fraction, or HF therapy at the time of incident HF diagnosis. HF hospitalization data were available in 15 trials, but only 2 included HF-related events within the primary composite endpoint. This systematic review highlights gaps in HF data capture within cardiovascular outcome trials of glucose-lowering therapies and outlines rationale and strategies for improving HF characterization.
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The role of sodium glucose co-transporter inhibitors in heart failure prevention
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Sodium–Glucose Cotransporter-2 Inhibitors and Heart Failure Prevention in Type 2 Diabetes
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- Authors
- Greene, S. J., Vaduganathan, M., Khan, M. S., Bakris, G. L., Weir, M. R., Seltzer, J. H., Sattar, N., McGuire, D. K., Januzzi, J. L., Stockbridge, N., & Butler, J.
- Affiliations
- Duke University (US)
- Brigham and Women's Hospital (US)
- John H. Stroger, Jr. Hospital of Cook County (US)
- University of Chicago (US)
- University of Maryland, Baltimore (US)
- University of Glasgow (GB)
- The University of Texas Southwestern Medical Center (US)
- Massachusetts General Hospital (US)
- United States Food and Drug Administration (US)
- University of Mississippi Medical Center (US)
- Corresponding author
- Butler, Javed
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2018-03
- Volume
- 71
- Issue
- 12
- Pages
- 1379-1390
- ISSN
- 0735-1097 (ISSN-L)
- PMC
- PMC5832063
- OpenAlex
- W2790767749
- Cited by
- 56
- References
- 71
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3 · 2023: 3 · 2022: 4 · 2021: 10 · 2020: 13 · 2019: 16 · 2018: 5
- FWCI
- 2.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Singulex
- European Commission
- Eisai
- Novo Nordisk
- Akebia Therapeutics
- Esperion Therapeutics
- National Institutes of Health (5t32hl069749-20, T32 HL069749)
- Relypsa
- National Heart, Lung, and Blood Institute (T32-HL069749, T32HL069749-14, U10HL110302, T32HL007604)
- National Institute of General Medical Sciences (U54GM115428)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092949)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- heart failure, type 2 diabetes, glucose-lowering therapy, cardiovascular outcome trials, heart failure hospitalization, heart failure incidence, heart failure prevalence, ejection fraction, heart failure functional class, heart failure treatment, drug labeling
- MeSH terms
- Clinical Trials as Topic, Diabetes Mellitus, Type 2, Heart Failure, Humans, Incidence, Prevalence, Treatment Outcome
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