Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA OKs Diabetes Drug Indication to Reduce CV Risk

Novo Nordisk news release; 2017 Aug 25

The FDA has approved a new indication for Victoza (liraglutide) 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.

Indications: Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist indicted:

  • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • To reduce the risk of major adverse CV events in adults with type 2 diabetes mellitus and established CV disease.

Dosage/administration: Inject subcutaneously in the abdomen, thigh, or upper arm. Administer once daily at any time of day, independently of meals. Initiate at 0.6 mg per day for 1 week then increase to 1.2 mg. Dose can be increased to 1.8 mg for additional glycemic control.

Adverse reactions: The most common adverse reactions, reported in ≥5% of patients treated with Victoza, include nausea, vomiting, decreased appetite, dyspepsia, and constipation.

Citation:

Victoza (liraglutide) is approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of three major adverse cardiovascular events. [news release]. Plainsboro, NJ: Novo Nordisk Inc. August 25, 2017. http://press.novonordisk-us.com/2017-08-25-Victoza-R-liraglutide-is-approved-in-the-US-as-the-only-type-2-diabetes-treatment-indicated-to-reduce-the-risk-of-three-major-adverse-cardiovascular-events. Accessed September 3, 2017.

Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc. 2017. http://www.novo-pi.com/victoza.pdf. Accessed August 30, 2017.