Diabetes Dialogue: SUMMIT and FINEARTS-HF, with Muthiah Vaduganathan, MD, MPH

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, welcome Muthiah Vaduganathan, MD, MPH, cardiologist and codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, for a discussion around topline data updates from the SUMMIT and FINEARTS-HF trials, the latter of which Vaduganathan served on as a trial investigator.

SUMMIT

On August 01, 2024, Eli Lilly and Company announced topline data from the SUMMIT trial, which examined use of tirzepatide (Mounjaro; Zepbound) 5mg, 10 mg, or 15 mg in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The first primary endpoint of SUMMIT was a composite endpoint of time-to-first occurrence of urgent heart failure visit, heart failure hospitalization, oral diuretic intensification and cardiovascular death to study completion and the second primary endpoint was the change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to week 52.¹

According to the announcement, results of the study indicate use of the dual GIP/GLP-1 receptor agonist was associated with statistically significant improvements in both primary endpoints, with a 38% relative risk reduction in time-to-first occurrence of heart failure outcomes relative to placebo therapy over 104 weeks of follow-up. Results also pointed to a statistically significant benefit on change from baseline in KCCQ-CSS (24.8 vs 15.0).¹

FINEARTS-HF

Less than a week later, on August 05, 2024, Bayer announced results from the phase 3 trial of their nonsteroidal mineralocorticoid receptor antagonist, finerenone (Kerendia), among patients with heart failure with mildly reduced or preserved ejection fraction. According to Bayer, FINEARTS-HF met its primary endpoint, achieving a statistically significant reduction of the composite of cardiovascular death and total heart failure events relative to placebo therapy.²

The trial is scheduled for presentation in a Hot Line session at the upcoming European Society of Cardiology Congress and Bayer plans to discuss the data and submission for regulatory approval with the US Food and Drug Administration.²

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others.

References:

1. Eli Lilly and Company. Lilly’s tirzepatide successful in phase 3 study showing benefit in adults with heart failure with preserved ejection fraction and obesity. Eli Lilly and Company. August 1, 2024. Accessed August 1, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-successful-phase-3-study-showing-benefit.
2. Bayer Pharmaceuticals. Bayer announces primary endpoint achieved in phase III FINEARTS-HF cardiovascular outcomes study investigating kerendia® (finerenone) in patients with heart failure with mildly reduced or preserved ejection fraction. Business Wire. August 5, 2024. Accessed August 5, 2024. https://www.businesswire.com/news/home/20240804941740/en/Bayer-Announces-Primary-Endpoint-Achieved-in-Phase-III-FINEARTS-HF-Cardiovascular-Outcomes-Study-Investigating-KERENDIA%C2%AE-finerenone-in-Patients-with-Heart-Failure-with-Mildly-Reduced-or-Preserved-Ejection-Fraction.