Diabetes drug gains FDA indication for CV benefit

Daniel Allar | | Cardiovascular Business | Heart Health

The diabetes drug liraglutide (Victoza) secured an indication from the FDA to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease, Novo Nordisk announced Aug. 25.

Approval came as a result of the LEADER trial, in which liraglutide demonstrated a 13 percent decreased risk in a composite of cardiovascular death, non-fatal heart attack and non-fatal stroke compared with placebo. The drug also showed an absolute risk reduction of 1.9 percent.

The LEADER trial, initiated in September 2010, included 9,340 patients with Type 2 diabetes from 32 countries. Follow-up time ranged from 42 months to five years.

"Today's news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events," Steve Marso, MD, and one of the primary investigators in LEADER said in a statement. "More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."

Liraglutide is the second diabetes drug to gain a cardiac indication. Empagliflozin (Jardiance) received FDA approval in December for reducing cardiovascular death risk in patients with Type 2 diabetes and coexisting cardiovascular disease.

""
Daniel Allar

Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.

Related Content

Medtronic receives key FDA clearance, launches new diabetes system
Martha Gulati highlights 'exciting' progress in preventive cardiology
Abbott opens CGM sensor manufacturing facility in Ireland as part of $465M investment
Cardiologist examines the latest breakthroughs in coronary inflammation research
Tirzepatide linked to significant weight loss, ‘impressive’ diabetes prevention after 3 years
No-contact blood pressure and diabetes screening with AI shows promise

Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."