FDA Approves Liraglutide for Cardiovascular Risk

Liraglutide showed a 13% reduction in major adverse cardiovascular events, reduced cardiovascular morbidity by 22%, and any morbidity by 15%.

The US Food and Drug Administration approved Novo Nordisk’s liraglutide (Victoza) injection for the treatment of cardiovascular risk in adults with type 2 diabetes.

"This approval marks an important milestone for millions of Americans living with type 2 diabetes, as cardiovascular disease is the number one cause of death in this patient population," Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in a statement. "Victoza now offers people with type 2 diabetes and established cardiovascular disease an effective treatment option to both lower their blood glucose and reduce their cardiovascular risk."

Liraglutide was shown to reduce the risk of major adverse cardiovascular events, such as nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death by 13%. It showed a 22% reduction in cardiovascular morbidity, a 15% reduction in any morbidity, and a 22% reduction in diabetic kidney disease in the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial.

The FDA had previously approved liraglutide in Jan. 2010 for the treatment of adults with type 2 diabetes, and under another brand name, Saxenda, for obesity treatment. The decision comes after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted to recommend liraglutide by a count of 17 to 2, in June.

The approval will allow for the addition to Victoza's label, which Novo Nordisk told MD Magazine would “provide important guidance to prescribers considering their options to treat” patients with type 2 diabetes.

"The increased risk for cardiovascular disease among patients with diabetes is well established, but awareness of these risks is relatively low, particularly as it relates to mortality," Todd Hobbs, MD, Vice President and Chief Medical Officer of Novo Nordisk North America, told MD Magazine. "In fact, cardiovascular disease is the leading cause of morbidity and mortality in patients with diabetes."

Hobbs added that clinicians "now have the option to choose a diabetes medication that also reduces their patient’s cardiovascular risk. Treatment options like Victoza that help to address critical aspects of diabetes care beyond glucose lowering are essential for proper diabetes management."

For Karol Watson, MD, a professor of medicine and cardiology, co-director of the UCLA Program in Preventive Cardiology, and Director of the UCLA Barbra Streisand Women’s Heart Health Program, when it comes to diabetes patients, lowering risk factors is the top priority.

"What we know is that diabetes is one of the most potent risk factors for cardiovascular disease," Watson said. "What we've known for years in the preventive cardiology program is that risk factor modification is the key. It underlies everything that we do."

Watson told MD Magazine that the one area of that was untouched by preventive medicine for some time has been diabetes, mainly due to a large availability of drugs that lower glycemia and microvascular issues. But no drug, until recently, has been able to address the macrovascular risks faced by diabetics.

Steven Nissen, MD, the chairman of Cardiovascular Medicine at the Cleveland Clinic, expressed concern about diabetes as an "epidemic" that has its most important consequences in the cardiovascular realm.

"By some estimates, as much as 60% to 70% of diabetics will die of heart disease," Nissen told MD Magazine. "Having drugs now that both help to control the blood sugar, but also control the cardiovascular consequences of diabetes, is a very big deal."

Nissen added that it has been a point of research for more than a decade and that the field is now seeing "the payoff of all that investment" in the form of these dual-purpose diabetes medications.

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