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Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes.

Publication ,  Journal Article
Greene, SJ; Vaduganathan, M; Khan, MS; Bakris, GL; Weir, MR; Seltzer, JH; Sattar, N; McGuire, DK; Januzzi, JL; Stockbridge, N; Butler, J
Published in: J Am Coll Cardiol
March 27, 2018

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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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 27, 2018

Volume

71

Issue

12

Start / End Page

1379 / 1390

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prevalence
  • Incidence
  • Humans
  • Heart Failure
  • Diabetes Mellitus, Type 2
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
 

Citation

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Greene, S. J., Vaduganathan, M., Khan, M. S., Bakris, G. L., Weir, M. R., Seltzer, J. H., … Butler, J. (2018). Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes. J Am Coll Cardiol, 71(12), 1379–1390. https://doi.org/10.1016/j.jacc.2018.01.047
Greene, Stephen J., Muthiah Vaduganathan, Muhammad Shahzeb Khan, George L. Bakris, Matthew R. Weir, Jonathan H. Seltzer, Naveed Sattar, et al. “Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes.J Am Coll Cardiol 71, no. 12 (March 27, 2018): 1379–90. https://doi.org/10.1016/j.jacc.2018.01.047.
Greene SJ, Vaduganathan M, Khan MS, Bakris GL, Weir MR, Seltzer JH, et al. Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes. J Am Coll Cardiol. 2018 Mar 27;71(12):1379–90.
Greene, Stephen J., et al. “Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes.J Am Coll Cardiol, vol. 71, no. 12, Mar. 2018, pp. 1379–90. Pubmed, doi:10.1016/j.jacc.2018.01.047.
Greene SJ, Vaduganathan M, Khan MS, Bakris GL, Weir MR, Seltzer JH, Sattar N, McGuire DK, Januzzi JL, Stockbridge N, Butler J. Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes. J Am Coll Cardiol. 2018 Mar 27;71(12):1379–1390.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

March 27, 2018

Volume

71

Issue

12

Start / End Page

1379 / 1390

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prevalence
  • Incidence
  • Humans
  • Heart Failure
  • Diabetes Mellitus, Type 2
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services