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Liraglutide does not improve clinical stability after hospitalization for HFrEF
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Use of the diabetes drug liraglutide among patients recently hospitalized with HF with reduced ejection fraction did not improve post-hospitalization clinical stability, according to new data from the FIGHT study.
“These findings do not support the use of liraglutide in this clinical situation,” Kenneth B. Margulies, MD, from Perelman School of Medicine, Smilow Center for Translational Research, University of Pennsylvania, Philadelphia, and colleagues wrote in JAMA.
Kenneth B. Margulies
The researchers sought to determine whether treatment with a glucagon-like peptide 1 agonist would improve clinical stability following hospitalization for acute HF. The phase 2, double blind, placebo-controlled, randomized FIGHT study was conducted at 24 U.S. hospitals from August 2013 to March 2015. Overall, 300 patients with established HF and reduced left ventricular EF who were recently hospitalized were randomly assigned to receive subcutaneous injection of liraglutide (Victoza, Novo Nordisk; n = 154) or placebo (n = 146). The liraglutide dose was increased to 1.8 mg per day during the first 30 days and continued for 180 days.
Patients enrolled had a mean age of 61 years, 21% were women and 59% had type 2 diabetes. The median LVEF was 25% and median N-terminal pro-B-type natriuretic peptide level was 2,049 pg/mL.
The primary endpoint was global rank score of time to death, time to HF rehospitalization and time-averaged proportional change in NT-proBNP. According to the findings, liraglutide had no significant effect on the primary endpoint compared with placebo (mean rank in liraglutide group = 146; mean rank in placebo group = 156; P = .31). The researchers also observed no significant difference in death between patients assigned liraglutide or placebo (12% vs. 11%, respectively; HR = 1.1; 95% CI, 0.57-2.14) or rehospitalization for HF (41% vs. 34%, respectively; HR = 1.3; 95% CI, 0.89-1.88).
Liraglutide also demonstrated no favorable effect on secondary outcomes including echocardiographic measures, 6-minute walk test distance or quality of life.
Results were similar in prespecified subgroup analyses of patients with diabetes, according to the researchers.
Investigator-reported hyperglycemic events were higher in the placebo group (18% vs. 10%). Hypoglycemic events were infrequent overall (1% liraglutide group vs. 3% placebo group), according to the results.
“Our findings are not relevant to patients already treated with GLP-1 agonists because such patients were specifically excluded from this trial. Larger safety trials may provide complementary insight into the safety of liraglutide and other GLP-1 agonists in patients with less severe and earlier stages of heart failure,” the researchers wrote. – by James Clark
Disclosure: The study drug (liraglutide) and matching placebo injections were supplied by Novo Nordisk. Margulies reports receiving grants from Celladon Corporation, Innolign Biomedical LLC, Juventis Therapeutics, Merck Sharp and Dohme, and Thoratec Corporation. He also reports consulting for Janssen Pharmaceuticals, Merck Sharp and Dohme, Pfizer and Ridgetop Research. Please see the full study for a list of other researchers’ relevant financial disclosures.
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