Experts: Expanded CV indication for Victoza ‘exciting’

Marilyn Tan

Shichun Bao

In patients with type 2 diabetes, cardiovascular disease is the leading cause of morbidity and death, according to the FDA.

Recently, the FDA approved an expanded indication for GLP-1 receptor agonist liraglutide (Victoza, Novo Nordisk) to allow its use in the reduction of major adverse cardiovascular events, myocardial infarction, stroke and CVD in adults with type 2 diabetes and established CVD, in addition to improving glucose control.

“In the last few years, there have been multiple cardiovascular outcome studies for new diabetes drugs,” Marilyn Tan, MD, chief of the Stanford Endocrine Clinic, told Healio Internal Medicine. “These trials were mandated by the FDA and were designed to show safety in high cardiovascular risk patients with type 2 diabetes. They were not intended nor expected to show a cardiovascular benefit, so when we saw cardiovascular risk reduction with liraglutide in the LEADER trial, this was exciting.”

There will likely be a surge in physician interest and prescriptions for liraglutide with the new approval, similar to when the FDA expanded the cardiovascular indication for empagliflozin (Jardiance, Boehringer Ingelheim), Tan said.

“This FDA indication is reassuring for patients already on the medication, and some providers may even switch patients from other GLP1 agonists to liraglutide for this reason,” she said. “If given an option between various GLP1 agonists, I expect more people will reach for liraglutide even though it’s a daily injection vs. weekly injections for other GLP1 agonists.”

The reason behind the cardiovascular benefit of liraglutide when some other GLP1 agonists have been neutral from a cardiovascular standpoint is not yet clear, Tan said.

“As a Vanderbilt physician who treats patients with diabetes every day, I am excited about the new FDA-approved indication of liraglutide,” Shichun Bao, MD, PhD, associate professor of medicine at the Vanderbilt Eskind Diabetes Clinic, Nashville, Tenn., told Healio Internal Medicine.

“The FDA issued guidance for industry in 2008 defining preapproval and postapproval requirements for the demonstration of cardiovascular safety for all new medications developed for glucose control in type 2 diabetes,” she added.

To date, the only diabetes drugs that have a heart benefit indication are liraglutide and empagliflozin, Bao noted.

“Physicians now have the option to choose a diabetes medication that also reduces patient’s CVD risk,” she said. “However, liraglutide is a very expensive medication and is not covered by every insurance plan at this time. We hope this medication can be less costly to our patients, and that all patients have access to this medication.” – by Alaina Tedesco

Disclosures: Tan and Bao report no relevant financial disclosures.