In the much-anticipated LEADER study, Novo Nordisk’s diabetes drug Victoza cut cardiovascular risks in patients with heart disease. Unfortunately, the drug didn’t deliver similar benefits to people with heart failure.
University of Pennsylvania researchers tested Victoza (liraglutide) in 300 heart failure patients with and without diabetes, to see whether the drug might stave off death, prevent hospitalizations and improve certain symptom measures. The drug failed to best placebo, with no significant effect on deaths or hospitalizations, the study found.
Over the 6-month study, 38% of participants were rehospitalized and 12% died.
“One goal was to see, completely independent of diabetes, whether liraglutide helps heart failure in people who already have a pretty advanced degree of heart failure,” said Dr. Kenneth Margulies, the study’s lead author (as quoted by heartwire). "On that we have a pretty definitive answer: no. We were hoping for improvement in heart failure, and we didn't get that at all.”
The new data, published on Tuesday in the Journal of the American Medical Association, did hint at some risks associated with using Victoza in patients with advanced heart failure. It was a Phase II study, and it wasn’t designed to deliver definitive outcomes data, Margulies noted. But doctors might want to think twice before starting advanced heart failure patients on Victoza if other diabetes meds work, he said.
"It does raise a safety concern," Margulies told the Philadelphia Inquirer. "They should not stop [liraglutide]. But if I have a heart-failure patient who needs more diabetes medication, I'd pick something else."
Margulies and his team had been following up on 2015 data suggesting that GLP-1 diabetes drugs like Victoza might help protect against heart failure in patients with diabetes. That study tapped healthcare records on 19,000 diabetic adults, and among its findings were a reduction in heart failure hospitalizations among diabetes patients using GLP-1 therapies.
The earlier study was retrospective and observational, rather than prospective, and, in contrast to the new study, nearly all of the patients had no history of heart failure, and all of them had diabetes. Because all the patients in the new study had established heart failure, they were at higher risk of complications.
For patients in earlier phases of heart failure, Victoza is probably a good bet, Margulies told heartwire, citing data from LEADER. Heart failure patients in that study did see their risk of death, stroke and heart attack reduced, he said.
Dr. David Lanfear, head of heart failure and transplant cardiology at Henry Ford Health System and a senior author of the earlier GLP-1 study, told the Inquirer that, given the discrepancies between the benefits found in that study and the lack of benefits in the latest data, Victoza might have “beneficial effects earlier in the [heart failure] disease process."
Victoza was the first GLP-1 drug to show a cardiovascular benefit in an outcomes trial; Sanofi’s lixisenatide, approved last week in the U.S. under the brand name Adlyxin, did not increase heart risks in its CV outcomes trial, but did not reduce them, either.
The LEADER data is seen as a potential marketing edge for Victoza, which has been losing market share to Eli Lilly’s weekly GLP-1 drug Trulicity, though it continues to grow sales. But the new data didn’t make a big enough impression--or Novo didn’t offer big enough discounts--to win Victoza a spot on Express Scripts’ 2017 national preferred formulary, announced earlier this week. The pharmacy benefits manager favored Trulicity instead. CVS Health, on the other hand, said its formulary includes both GLP-1 drugs.
Novo is working on its own weekly GLP-1, semaglutide, and it anticipates filing that med for FDA approval later this year.
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