Victoza® (liraglutide) significantly reduced the risk of major cardiovascular events and death in adults with type 2 diabetes in the LEADER trial

News provided by

Jun 13, 2016, 05:15 ET

NEW ORLEANS, June 13, 2016 /PRNewswire/ --

Novo Nordisk today announced that Victoza^® (liraglutide) injection 1.2 mg or 1.8 mg significantly reduced the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo (95% confidence interval [CI]: 0.78; 0.97, p=0.01), when added to standard of care in 9,340 adults with type 2 diabetes at high CV risk. The main results of the LEADER trial were presented today at the American Diabetes Association's 76th Scientific Sessions (ADA 2016) and also published in the New England Journal of Medicine.^[¹^]^,^[²^] Victoza^® is the only approved GLP-1 receptor agonist to demonstrate a superior reduction of major CV events vs placebo, both on top of standard of care, in a cardiovascular outcomes trial.

There was a significant 22% reduction in cardiovascular death with Victoza^® treatment vs placebo (95% CI: 0.66; 0.93, p=0.007) and reductions in non-fatal myocardial infarction (HR=0.88, 95% CI: 0.75; 1.03, p=0.11) and non-fatal stroke (HR=0.89, 95% CI: 0.72; 1.11, p=0.30).^[¹^]^,^[²^]

"These findings are exciting, as it demonstrates that Victoza^® can improve outcomes beyond glucose reduction and weight loss by helping to avoid cardiovascular complications and death in people with type 2 diabetes," said Dr. John Buse, chairman of the LEADER Steering Committee and chief of Endocrinology and director of the Diabetes Care Centre at the University of North Carolina School of Medicine. "Type 2 diabetes treatments that can also reduce cardiovascular risk are important since cardiovascular disease is the leading cause of death worldwide in this patient population."

All-cause death was significantly reduced by 15% with Victoza^® compared to placebo (95% CI: 0.74; 0.97, p=0.02). The expanded CV endpoint was significantly reduced by 12% with Victoza^® compared to placebo (95% CI: 0.81; 0.96, p=0.005). The expanded CV endpoint included the three components of the primary endpoint in addition to unstable angina leading to hospitalisation, coronary revascularisation and hospitalisation for heart failure.^[¹^]^,^[²^]

From a mean baseline of 8.7% (both groups), there was a greater reduction in HbA_1c with Victoza^® vs placebo, both on top of standard of care, at three years (estimated treatment difference [ETD]: -0.40%, 95% CI: -0.45; -0.34). Weight loss was also sustained over three years with Victoza^® treatment vs placebo (ETD: -2.3 kg, 95% CI: -2.5; -2.0). Mean baseline weight was 91.9 kg and 91.6 kg, respectively.^[¹^]^,^[²^]

"We are very excited by the LEADER trial results that demonstrate a significant reduction in major cardiovascular events among type 2 diabetes patients treated with Victoza^®, including all-cause death," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "For us, this marks the beginning of a new era where our R&D focus will go beyond glucose control."

The proportion of adults experiencing adverse events was similar between the Victoza^® and the placebo groups (62.3% vs 60.8, respectively). The most common adverse events leading to the discontinuation of Victoza^® were gastrointestinal events. The incidence of pancreatitis was non-significantly lower in the Victoza^® group than in the placebo group.^[¹^]^,^[²^]

About LEADER

LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term effects of Victoza^® (liraglutide up to 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.

LEADER was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries that were followed for 3.5-5 years. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.^[²^]

Indication and Usage

What is Victoza^®?

Victoza^® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.

Victoza^® is not recommended as the first choice of medicine for treating diabetes.
It is not known if Victoza^® can be used in people who have had pancreatitis.
Victoza^® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if Victoza^® can be used with mealtime insulin.
It is not known if Victoza^® is safe and effective for use in children.

Important Safety Information

What is the most important information I should know about Victoza^®?

Victoza^® may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza^® and medicines that work like Victoza^® caused thyroid tumors, including thyroid cancer. It is not known if Victoza^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Victoza^®?

Do not use Victoza^® if:

you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you are allergic to liraglutide or any of the ingredients in Victoza^®.

What should I tell my health care provider before using Victoza^®?

Before using Victoza^®, tell your health care provider if you:

have or have had problems with your pancreas, kidneys, or liver.
have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Victoza^®?

Do not mix insulin and Victoza^® together in the same injection.
You may give an injection of Victoza^® and insulin in the same body area (such as your stomach area), but not right next to each other.
Do not share your Victoza^® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What are the possible side effects of Victoza^®?

Victoza^® may cause serious side effects, including:

inflammation of your pancreas (pancreatitis). Stop using Victoza^® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
serious allergic reactions. Stop using Victoza^® and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.

The most common side effects of Victoza^® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.

Please click here for Prescribing Information and Medication Guide

About Victoza^® (liraglutide)

Victoza^® is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

As of March 2015, Victoza^® has been commercially launched in 75 countries, including the United States, Canada, Japan, United Kingdom, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia and China.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk-us.com or follow us on Twitter.

Further information

Media:
Katrine Sperling
+45-4442-6718
[email protected]

Chris Clark (US)
+1-609-619-1831
[email protected]

Ken Inchausti (US)
+1-609-786-8316
[email protected]

Investors:
Peter Hugreffe Ankersen
+45-3075-9085
[email protected]

Melanie Raouzeos
+45-3075-3479
[email protected]

Kasper Veje (US)
+1-609-235-8567
[email protected]

_______________________

References

1. Results of the liraglutide effect and action in diabetes - evaluation of cardiovascular outcome results (LEADER) trial. Symposium 3-CT-SY24 at the 76th Scientific Sessions of the American Diabetes Association (ADA). 13 June 2016.

2. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine. 2016; In Press. DOI: 10.1056/NEJMoa1603827.

SOURCE Novo Nordisk