STEPS

New Drug Reviews

Oral Semaglutide (Rybelsus) for the Treatment of Type 2 Diabetes Mellitus

 

Am Fam Physician. 2020 Nov 15;102(9):627-628.

Oral semaglutide (Rybelsus) is a glucagon-like peptide-1 (GLP-1) receptor agonist labeled as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It reduces hyperglycemia by increasing insulin secretion and decreasing glucagon secretion.

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DrugDosageDose formCost*

Semaglutide (Rybelsus)

3 mg once per day, titrating to 14 mg per day if needed

Tablets: 3 mg, 7 mg, 14 mg

$850


*—Estimated lowest GoodRx price for one month of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed October 7, 2020; zip code: 66211).

DrugDosageDose formCost*

Semaglutide (Rybelsus)

3 mg once per day, titrating to 14 mg per day if needed

Tablets: 3 mg, 7 mg, 14 mg

$850


*—Estimated lowest GoodRx price for one month of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed October 7, 2020; zip code: 66211).

Safety

Similar to other medications in this class, semaglutide carries the risk of an increased incidence of thyroid C-cell tumors, including medullary thyroid carcinoma.1 Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 should not be prescribed oral semaglutide. Serious adverse effects are similar to those of other GLP-1 receptor agonists, including pancreatitis, diabetic retinopathy complications, hypoglycemia with concomitant use of insulin secretagogues or insulin, acute kidney injury, and hypersensitivity reactions (less than 1% to 3%).1 Oral semaglutide has not been studied in pregnant patients or breastfed infants.1

Tolerability

Approximately 30% to 50% of patients taking oral semaglutide will experience gastrointestinal adverse effects. Nausea, vomiting, diarrhea, dyspepsia, and constipation are the most common. Abdominal pain, eructation, gastroesophageal reflux disease, and gastritis have been reported but are less common.2 In clinical trials, the dropout rate due to adverse effects is 8% to 16%.2

Effectiveness

Oral semaglutide improves glycemic control in adults with type 2 diabetes better than placebo and is noninferior to subcutaneous semaglutide.2 Although oral semaglutide

Address correspondence to Stephen A. Wilson, MD, MPH, FAAFP, at stephen.wilson@bmc.org. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. Daily Med. Drug label information. Rybelsus—oral semaglutide tablet. Accessed June 20, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98...

2. Davies M, Pieber TR, Hartoft-Nielsen ML, et al. Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes: a randomized clinical trial. JAMA. 2017;318(15):1460–1470.

3. Husain M, Birkenfeld AL, Donsmark M, et al.; PIONEER 6 Investigators. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2019;381(9):841–851.

4. 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.

5. Han Y, Xie H, Liu Y, et al. Effect of metformin on all-cause and cardiovascular mortality in patients with coronary artery diseases: a systematic review and an updated meta-analysis. Cardiovasc Diabetol. 2019;18(1):96.

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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