In late January 2010 the FDA approved Novo Nordisk’s newest medication, Victoza® (liraglutide), which is the first Glucagon Like Peptide-1 (GLP-1) analogue approved for the treatment of type 2 diabetes mellitus. Unlike Byetta® (exenatide), the only other medication currently available in the GLP-1 receptor agonist class and a GLP-1 mimetic, Victoza® is 97% homologous with natural GLP-1 and is produced by recombinant DNA technology.

Victoza® was approved to treat adults with type 2 diabetes mellitus in conjunction with diet and exercise in use with other oral anti-diabetic medications or in monotherapy but not for use with insulin. Victoza® is indicated once daily at anytime with no regard to meals as a subcutaneous injection and was shown in the Liraglutide Effect and Action in Diabetes (LEAD)-6 trial to have superior fasting and post-prandial glucoses reductions as well as superior A1c reductions when compared to Byetta ®.

The most common side effects are nausea and vomiting which typically resolved within 16 weeks of beginning therapy and Victoza® has also been shown to have the beneficial therapeutic effects of appetite suppression and early satiety which can lead to beneficial weight loss. Hypoglycemia was seen in the clinical trials but mainly in patients who were also taking a sulfonylurea.

In pre-clinical trial there was an increased incidence of thyroid c-cell tumors in mice and rats the FDA is therefore requiring Novo Nordisk to monitor tumor registries to identify any increase in reported c-cell tumors in humans. After my review of all the human and primate data I do not believe there is any significant human risk that should limit it’s use.  However, due to this rodent data Victoza® is contraindicated in patients with a personal or family history of Medullary Thyroid Carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. As with all Byetta® and the DPP-4 inhibitors, Januvia® and Onglyza®, if pancreatitis develops Victoza® should be stopped and not restarted.

Victoza® is administered as a subcutaneous injection with a pen device very similar to the FlexPen® used with other Novo Nordisk products. The pen is capable of delivering all three Victoza® doses, 6, 12, and 18 mg. Victoza® should be initiated at 6 mg daily for 1 week then increase to 12 mg daily and patients can be increased to the 18 mg dose if the provider deems this to be appropriate.

After reviewing all of the six LEAD trials, the pre-clinical rodent and primate data, and the package insert I believe Victoza® to be an excellent addition to the currently available anti-diabetic medication. With once daily dosing, excellent efficacy, an easy to use pen that is capable of delivering all three doses, dosing convenience anytime of the day with no regard to meals, and improvement of the most common side effect of nausea back to near placebo levels by 16 weeks of therapy I believe Victoza® will be a therapeutic force to be reckoned with.

 

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