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Glucose Drug Reduces Heart Disease in People with Diabetes

Heart in rib cage illustration

(CIRM.gov)

14 June 2016. A drug to reduce glucose levels was shown in a clinical trial to reduce serious heart disease in people with type 2 diabetes also at high risk of heart disease. Results of the late-stage trial testing the drug liraglutide, marketed by drug-maker Novo Nordisk under the brand name Victoza, appear in yesterday’s issue of New England Journal of Medicine. The findings were also presented yesterday at a scientific meeting of American Diabetes Association.

Type 2 diabetes is a disorder where the pancreas produces some, but not enough insulin, or the body cannot process insulin, and accounts for some 90 percent of all diabetes cases. Diabetes can also affect the heart and blood vessels, leading to coronary heart disease, heart attack, and stroke. According to International Diabetes Federation, cardiovascular disease is the most common cause of death in people with diabetes.

Liraglutide is in a class of drugs known as glucagon-like peptide-1 receptor agonists, hormones that generate a greater insulin response, and thus help regulate blood glucose levels. These drugs also reduce glucagon that raises glucose levels and induce satiety, or feeling, full after eating, thus help control weight. Liraglutide is a long-acting drug, prescribed for people who find it difficult to control their blood glucose levels through diet and exercise and need extra help.

The clinical trial enrolled 9,340 individuals with type 2 diabetes at 410 sites in 32 countries. Participants were randomly assigned to receive injections of liraglutide or a placebo under the skin each day, in doses starting from 0.6 milligrams and increasing to 1.8 milligrams over 3 weeks. In addition to either liraglutide or placebo, individuals in the trial took other drugs to control their diabetes, high blood pressure, or cholesterol. Participants were on average 64 years old and nearly three-quarters (73%) had a previous history of heart disease.

After the initial treatments, the research team led by John Buse at University of North Carolina medical school in Chapel Hill, followed up with participants after 30 and 90 days, then every 6 months from 3.5 to 5 years. Individuals in the trial took electrocardiograms and gave blood and urine samples at the beginning of the study, then at each of the follow-up points, where the researchers checked for signs of cardiovascular or kidney disease.

The results show a 22 percent reduction in death from cardiovascular causes among participants receiving liraglutide compared to placebo recipients. Liraglutide recipients also had a 13 percent lower risk of non-fatal heart attack or non-fatal stroke, and 15 percent lower risk of mortality for any reason. In addition, participants receiving liraglutide had a 22 percent lower risk of advanced diabetic kidney disease than their counterparts receiving the placebo.

Percentages of participants experiencing adverse effects were about the same in both groups. Instances of abnormal tissue growth were slightly higher among liraglutide recipients, while individuals receiving the placebo had somewhat more cases of pancreatitis. In neither case were the differences large enough to be statistically reliable.

FDA first approved liraglutide for control of blood glucose levels in 2010, but the trial results highlight the drug’s additional value to people with diabetes. “Type 2 diabetes treatments that can also reduce cardiovascular risk are important,” says Buse in  Novo Nordisk statement, “since cardiovascular disease is the leading cause of death worldwide in this patient population.”

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