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Liraglutide Makes Diabetic HF Patients Cautious
Date: October 23rd, 2016
MD Kenneth Margulies from the Perelman School of Medicine in Philadelphia and a lead author said that the group getting GLP-1 agonist liraglutide treatment showed insignificant differences (12% vs. 11%). The type 2 diabetes patients were included here. Margulies and colleagues reported that rehospitalizations for patients with heart failure similarly had no significant difference. In addition, the study could not locate any difference between placebo and treatment of any of the said prespecified endpoints. But the researchers noted that the type 2 diabetes group showed the possibility of worse outcomes.
Findings of the Study
The researchers noted that this was the first time a multicenter clinical trial had been put in place to find out if high-risk subsets of patients with an advanced heart failure benefit from GLP-1 agonist liraglutide. Preliminary results had been submitted last year at the American Heart Association Scientific Sessions.
Margulies and colleagues said that GLP-1 made no improvements on the stability of patients with advanced heart failure post hospitalization. But instead, it lowered left ventricular ejection fraction (LVEF). This meant that it opposed prior results, which showed that GLP-1 therapy has the ability to ameliorate the mechanisms of resistance to myocardial insulin as seen in patients that have severe cardiomyopathies. In supporting the conclusion that liraglutide does not boost the status of heart failure, they cited the lack of liraglutide favorable effects such as quality of life, a walk distance of 6 minutes.
How the study was conducted
The study was done on 300 patients that had been recently hospitalized due to heart failure. The median age for the subjects was 61, of which 21 percent were women while 65 percent depicted the symptoms of New York Heart Association (NYHA) class III. 5 percent of these were from NYHA class IV.
The patients were given a subcutaneous injection of either placebo or liraglutide per day after being randomly grouped 1:1. The liraglutide dose was increased to 1.8 milligrams per day in the initial 30 days and went on for 180 days.
Support for the study
George Grunberger, MD, from the Grunberger Diabetes Institute in Bloomfield Hills, Mich and former American Association of Clinical Endocrinologists (AACE) president said that the Phase II study was an interesting one and had some few additions to make. He said that there was a reason why a given synthetic GLP-1 receptor agonist like liraglutide would copy the effects of chronic infusion.
Grunberger said that it was disappointing considering there was hope for finding some use of GLP-1 receptor agonists past the glycemic therapy in diabetes.
Implication for the diabetes patients
The outcome of the study was that the differences between groups of 178 patients were insignificant. However, the trend seemed to show worse outcomes prompting the researchers to caution when initiating GLP-1 agonists in diabetic HF patients. However, some experts who did not take part in the research saw no need to be concerned.
Robert Eckel, MD, from University of Colorado Anschutz Medical Campus in Aurora said that the research team’s statement was more alarming, but it needed further validation.