Author + information
- Stephen Greene,
- Muthiah Vaduganathan,
- Muhammad Khan,
- George Bakris,
- Matthew Weir,
- Jonathan Seltzer,
- Naveed Sattar,
- Darren McGuire,
- James Januzzi,
- Norman Stockbridge and
- Javed Butler
Since the United States Food and Drug Administration (FDA) issued an industry guidance in 2008, many cardiovascular outcome trials have studied important cardiovascular risks and benefits of novel glucose lowering therapies. The rigor and extent of ascertainment of heart failure (HF)-related data in these trials has not been systematically characterized.
All large (N >1,000), completed, and published phase III or IV cardiovascular outcome trials evaluating glucose lowering therapies in adults through June 2017 were identified using a comprehensive search (Cochrane library, EMBASE, PubMed, Scopus, ClinicalTrials.gov). Data regarding baseline HF characterization, incident HF ascertainment, and HF endpoint reporting were abstracted from trial publications, FDA Advisory Committee Records, and FDA drug labeling documents.
Overall, 21 trials evaluating 123,295 patients were included. Baseline prevalence of HF was reported in 15 (71%) trials, ranging from 0.5% to 27.9%, but none included data regarding functional class, ejection fraction, or HF therapy. Among 20 trials with published results, incident HF was reported in 5 (25%) trials, but these events were inconsistently defined and no trial reported patient characteristics at the time of HF diagnosis. Data regarding rates of hospitalization for HF were available in 15 (75%) trials, but only 2 (10%) included a HF-related event within the primary composite endpoint.
This systematic review highlights important gaps in baseline profiling of HF, the ascertainment of incident HF, and the characterization of HF events during follow-up within contemporary cardiovascular outcome trials of glucose lowering therapies. Given the increasing number of patients with both HF and diabetes and the multiple examples of glucose lowering therapies influencing risk of HF events, improved characterization of HF in cardiovascular outcome trials of patients with diabetes is needed.
Poster Hall, Hall A/B
Saturday, March 10, 2018, 3:45 p.m.-4:30 p.m.
Session Title: Cardiac Biomarkers and Acute Heart Failure
Abstract Category: 13. Heart Failure and Cardiomyopathies: Clinical
Presentation Number: 1147-110
- 2018 American College of Cardiology Foundation