The U.S. Food and Drug Administration (FDA) recently approved Victoza® (liraglutide) for a new indication: to reduce the risk of heart attack, stroke, and death from cardiovascular disease in adults who have type 2 diabetes and cardiovascular disease. Victoza is a human glucagon-like peptide-1 (GLP-1) analog that has been previously approved by the FDA to help with blood sugar control in people with type 2 diabetes. This new treatment application for Victoza was based on a long-term, international clinical trial, called LEADER.1,2
About the LEADER study
LEADER stands for Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results. The LEADER clinical trial was conducted by 410 centers in 32 countries. LEADER enrolled 9,340 people with type 2 diabetes who were at high risk for cardiovascular events, like heart attacks and strokes. Patients were randomly assigned to receive either Victoza or placebo (an inactive substance) in addition to standard care, which included lifestyle modification, treatments for blood sugar control, and cardiovascular medications. Patients were then followed for a minimum of 42 months and a maximum of 60 months. The average time of follow-up was 3.8 years.3
The trial measured several outcomes among the patients: non-fatal heart attacks, non-fatal strokes, and deaths by heart attack or stroke. The rate of all three were lower in the Victoza group than in the placebo group. Victoza demonstrated a life-saving benefit of a 22% reduction in cardiovascular death, as well as a 15% reduction in death of all causes.1,3
Cardiovascular disease and type 2 diabetes
Cardiovascular disease (or heart disease) is the leading cause of death and illness among adults with type 2 diabetes.4 Cardiovascular disease includes conditions that involve narrowed or blocked blood vessels and can lead to conditions including heart failure, arrhythmia (abnormal rhythm of the heart), heart valve problems, heart attack (when blood flow to a part of the heart is blocked), and stroke (when blood flow to the brain is blocked).5
Although controlling diabetes and managing blood sugar is critical to reducing the risk of heart disease, people with type 2 diabetes are at a greater risk of cardiovascular events even when their diabetes is under control. The new indication for Victoza gives doctors and patients a new treatment option to consider for both blood sugar control and reducing the risk of cardiovascular events.1
Possible side effects with Victoza
Like all medications, Victoza can cause side effects, some of which are serious. The most common side effects experienced by people taking Victoza are headache, nausea, diarrhea, vomiting, hypoglycemia (low blood sugar), and a decrease in appetite. Victoza may cause thyroid tumors, including cancer. If you experience a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, you should talk to your doctor about your symptoms.1,2
Other things to know about Victoza
Some people should not use Victoza, including people who are allergic to the active ingredient liraglutide or any of the other ingredients in Victoza, people who have a personal or family history of medullary thyroid carcinoma (MTC), or people who have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).2
Before taking Victoza, you should talk to your doctor about all your health conditions, especially:
Thyroid C-cell tumors
Acute gallbladder disease
Stomach problems, such as slowed emptying of the stomach (gastroparesis) or problems digesting food
Pregnancy or breastfeeding2
Talk to your doctor or pharmacist about all prescription and over-the-counter medications you are taking, as well as any vitamins, nutritional supplements, and herbal products you take before taking Victoza.2
Novo Nordisk press release. Accessed online on 9/1/17 at http://press.novonordisk-us.com/2017-08-25-Victoza-R-liraglutide-is-approved-in-the-US-as-the-only-type-2-diabetes-treatment-indicated-to-reduce-the-risk-of-three-major-adverse-cardiovascular-events.
Victoza prescribing information. Accessed online on 9/1/17 at http://www.novo-pi.com/victoza.pdf.
Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2016; 375:311-322.
Low Wang CC, Hess CN, Hiatt WR, Goldfine AB. Clinical Update: cardiovascular disease in diabetes mellitus. Atherosclerotic cardiovascular disease and heart failure in type 2 diabetes mellitus–mechanisms, management, and clinical considerations. Circulation. 2016; 133:2459-2502.
American Heart Association. Accessed online on 9/1/17 at http://www.heart.org.