STEPS

New Drug Reviews

Semaglutide (Ozempic) for Type 2 Diabetes Mellitus

 

Am Fam Physician. 2019 Jul 15;100(2):116-117.

Semaglutide (Ozempic) is a glucagon-like peptide-1 (GLP-1) receptor agonist labeled for the treatment of type 2 diabetes mellitus in adults.1

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DrugDosageDose formCost*

Semaglutide (Ozempic)

0.25 mg once weekly for four weeks, increasing to 0.5 mg once weekly

0.25-mg/0.5-mg or 1-mg prefilled pen for subcutaneous injection

$800


*—Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed May 28, 2019).

DrugDosageDose formCost*

Semaglutide (Ozempic)

0.25 mg once weekly for four weeks, increasing to 0.5 mg once weekly

0.25-mg/0.5-mg or 1-mg prefilled pen for subcutaneous injection

$800


*—Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed May 28, 2019).

Safety

As with other GLP-1 receptor agonists, semaglutide should not be used as first-line treatment because of a potential risk of thyroid cancer, based on animal studies.1 It should not be used in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2.

When used alone, semaglutide has not been shown to increase the risk of severe hypoglycemia (i.e., glucose levels of 56 mg per dL [3.1 mmol per L] or less) compared with placebo.1 However, the risk is increased when semaglutide is added to other treatments such as basal insulin or a sulfonylurea. The effect of semaglutide on hypoglycemia rates has not been studied when used with metformin alone.

Pancreatitis will occur about three times per 1,000 patient-years. Semaglutide should not be used in patients with a history of pancreatitis because it has not been studied in this patient population.1 Cholelithiasis will affect about 2% of patients per year.1 Diabetic retinopathy complications requiring treatment may be more common with semaglutide than with placebo. In a trial of 3,297 patients, most of whom had preexisting retinopathy, diabetic retinopathy complications occurred in 3% of those taking semaglutide vs. 1.8% of the placebo group.2 This increase has not been documented with other GLP-1 receptor agonists. Patients with a history of diabetic retinopathy should be monitored for disease progression.1

Semaglutide should not be used in children. It has not been studied in pregnant or breastfeeding women, and the manufacturer recommends stopping treatment at least two months before attempting pregnancy.1

Tolerability

Semaglutide is generally well tolerated with similar dropout rates when compared with placebo,

Address correspondence to Shaunta Chamberlin, PharmD, BCPS, at schamberlin@utmck.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. Daily Med. Drug label information: Ozempic—semaglutide injection, solution. Accessed January 2, 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79...

2. Marso SP, Bain SC, Consoli A, et al.; SUSTAIN-6 Investigators. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–1844.

3. Pratley RE, Aroda VR, Lingvay I, et al.; SUSTAIN 7 Investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275–286.

4. Marso SP, Daniels GH, Brown-Frandsen K, et al.; LEADER Steering Committee; LEADER Trial Investigators. Liraglu-tide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322.

5. Rosenstock J, Perkovic V, Johansen OE, et al.; CARMELINA Investigators. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321(1):69–79.

6. Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Assistant Medical Editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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