31 Aug Victoza® Receives FDA Approval To Reduce Heart Attack and Stroke in Patients With Type 2 Diabetes and Heart Disease
MedicalResearch.com Interview with:
Dr. Hobbs
Todd Hobbs, MD
Vice President and Chief Medical Officer
Novo Nordisk North America
MedicalResearch.com: Would you tell us a little about liraglutide? How does it work to control diabetes/blood sugar?
Response: Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration (FDA) in 2010 to help lower blood sugar in adults with type 2 diabetes. Victoza® is the #1 prescribed (GLP-1) receptor agonist.
Victoza® is a non-insulin, once-a-day medication that helps lower blood sugar levels in adults with type 2 diabetes by increasing glucose-dependent insulin release, inhibiting glucagon secretion, and slowing gastric emptying.
On August 25, the FDA approved a new indication for Victoza®, making it the only type 2 diabetes treatment approved to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.
MedicalResearch.com: What are the main results of the LEADER trial?
Response: The new Victoza® indication to reduce the risk of major adverse CV events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease is based on robust results from the landmark LEADER trial. This long-term (3.5-5year) cardiovascular outcomes trial showed Victoza®:
- Significantly reduced the risk of a three component endpoint consisting of CV death, non-fatal heart attack or non-fatal stroke by 13% vs placebo with an absolute risk reduction (ARR) of 1.9%, when added to standard of care in 9,340 adults with type 2 diabetes and established CV risk.
- Demonstrated a life-saving benefit that included a 22% reduction in CV death and a 15% reduction in all-cause death (ARR 1.3%, 1.4% respectively).
MedicalResearch.com: Why is this announcement important? How does Victoza® differ from other medications for diabetes?
Response: As the #1 prescribed GLP-1, physicians have come to rely on Victoza® as an effective therapy for lowering A1C in patients with type 2 diabetes, and with this new indication, they now have the option to choose a diabetes medication that also reduces their patient’s CV risk. Patients with type 2 diabetes are at increased risk for CV events, so treatment options like Victoza® that help to address critical aspects of diabetes care beyond glucose lowering are essential for diabetes management.
MedicalResearch.com: What should readers take away from your report?
Response: Victoza® is the only type 2 diabetes treatment approved by the FDA to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: Type 2 diabetes management requires solutions that address critical aspects of diabetes care beyond A1C reduction, as adults with diabetes are up to four times more likely to develop cardiovascular disease.
- Cardiovascular disease is the leading cause of morbidity and mortality in patients with diabetes.
- Cardiovascular disease accounts for 50% or more of diabetes-related death.
- People with diabetes and established CV disease have a higher risk of further CV events and a shorter life expectancy than adults without diabetes.
The risk for heart attack and stroke remains even for patients who have reached their A1C goals.
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Citation:
Novo Nordisk received approval from the FDA on a new indication for Victoza® to reduce the risk of major adverse cardiovascular events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.
Press Release:
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on August 31, 2017 by Marie Benz MD FAAD