Clinical Edge

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

FDA Approves Ozempic for Treatment of T2D

Novo Nordisk news release; 2017 Dec 5

The FDA has approved Ozempic (semaglutide) injection for the treatment of adults with type 2 diabetes.

Indications: Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is not recommended as first-line therapy for patients inadequately controlled on diet and exercise.

Dosage and administration: Inject subcutaneously in the abdomen, thigh, or upper arm. Start at 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly. If after at least 4 weeks additional glycemic control is needed, increase to 1 mg once weekly. Administer once weekly at any time of day, with or without meals. If a dose is missed, administer within 5 days of missed dose.

Adverse reactions: The most common adverse reactions (≥5% of patients) are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Citation:

Novo Nordisk receives FDA approval of OZEMPIC (semaglutide) injection for the treatment of adults with type 2 diabetes. [news release]. Novo Nordisk; Plainsboro, NJ; December 5, 2017. http://press.novonordisk-us.com/2017-12-5-Novo-Nordisk-Receives-FDA-Appr.... Accessed December 8, 2017.

This Week's Must Reads

AHA Statement: Accurate Measurement of BP, Hypertension; ePub 2019 Mar 4; Muntner, et al

Coffee Consumption & Plasma Biomarkers, Am J Clin Nutr; ePub 2019 Mar 5; Hang, et al

Is Adding Aspirin to Warfarin Therapy Beneficial? , JAMA Intern Med; ePub 2019 Mar 4; Schaefer, et al

Urinary Oxalate Excretion & Risk of CKD Progression, JAMA Intern Med; ePub 2019 Mar 4; Waikar, et al

Psychosocial Stress & CV Health in Older Women, Circulation; ePub 2019 Feb 28; Burroughs-Peña, et al

Must Reads in Diabetes

Insulin Management in Patients with T2D, Lancet; ePub 2019 Feb 22; Bergenstal, et al

Hospitalization Rates in Young-Onset Diabetes, Ann Intern Med; ePub 2019 Jan 15; Ke, Lau, et al

Long-Term Absolute Risk for CVD by FG Level, Diabetes Care; ePub 2019 Jan 7; Bancks, et al

Prediabetes Status & Lifestyle Modification , J Am Board Fam Med; 2019 Jan 4; Owei, et al

Second-Line ADMs & CV Events in T2D, JAMA Netw Open; ePub 2018 Dec 21; O’Brien, et al