Victoza New Treatment Option for Type 2 Diabetes
If you have type 2 diabetes, the new drug Victoza (liraglutide), which just won the approval of the Food and Drug Administration (FDA), may be an option for better control of blood sugar (glucose) levels. The once-daily injectable treatment is not for all type 2 diabetes patients, however.
People who have type 2 diabetes have an arsenal of prescription medications at their disposal. The addition of Victoza, which belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists, is an option for a selected population of individuals with this disease. Diabetes affects more than 23 million people in the United States, according to the American Diabetes Association, and 246 million people worldwide. Ninety to 95 percent of people with diabetes have type 2 disease.
Liraglutide is not the only drug in the GLP-1 class. Exenatide (Byetta), which is taken twice daily, is already on the market and was the first drug released in this category. Amylin Pharmaceuticals, which makes exenatide, is currently working with Eli Lilly and Alkermes Inc. to develop a once-weekly injection of exenatide.
Victoza facilitates the production of insulin by the pancreas after people have eaten. It is intended to be used along with diet, exercise, and other antidiabetes medications, but it is not recommended as the first line of treatment for patients who have not achieved adequate control of their blood sugar through use of diet and exercise. It also is not indicated for people at risk for medullary thyroid cancer and should be used with caution among people who have a history of pancreatitis (inflammation of the pancreas).
Risks of Victoza Use
During the course of five clinical trials that involved more than 3,900 subjects, pancreatitis occurred more often in patients who took Victoza than in those who were taking other antidiabetes drugs. Anyone who takes Victoza and who experiences severe abdominal pain should stop taking the drug immediately and contact their physician right away. Common side effects associated with use of Victoza during the trials included nausea, headache, and diarrhea, as well as allergic-like reactions such as hives and breathing difficulties.
Although Victoza has been approved for use in type 2 diabetes, patients should be aware that the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) as a condition of the drug’s approval. This means that the pharmaceutical company (the drug is manufactured by Novo Nordisk of Bagsvaerd, Denmark) must include a Medication Guide for patients and a Communication Plan for healthcare providers, as well as conduct additional studies to evaluate the risks associated with using this medication, including a large trial to assess cardiovascular safety and a five-year epidemiological study to evaluate thyroid and other cancer risks, hypoglycemia, pancreatitis, and allergic reactions.
FDA approved Victoza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Victoza is not recommended as first-line therapy for patients who have not achieved adequate control of their blood sugar levels through use of diet and exercise. Additionally, Victoza is not a substitute for insulin and should not be used in patients who have type 1 diabetes. The drug is now clearly in competition with the only other drug in its class, Byetta.
American Diabetes Association
Food and Drug Administration