STEPS

New Drug Reviews

Albiglutide (Tanzeum) for Diabetes Mellitus

 

Am Fam Physician. 2017 Apr 15;95(8):521-522.

Albiglutide (Tanzeum) is a glucagon-like peptide 1 (GLP-1) receptor agonist labeled as an adjunct to diet and exercise for the management of type 2 diabetes mellitus in adults. As with other GLP-1 receptor agonists, albiglutide stimulates postmeal insulin secretion and slows gastric emptying to promote satiety.1 Albiglutide can be used alone or in combination with metformin, sulfonylureas, thiazolidinediones, or basal insulin.25 It has not been studied in combination with prandial insulin.

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DrugDosageDose formCost*

Albiglutide (Tanzeum)

30 mg once per week initially, and increased to 50 mg once per week if needed to improve A1C

30-mg and 50-mg pens for subcutaneous injection

$500


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed January 11, 2017).

DrugDosageDose formCost*

Albiglutide (Tanzeum)

30 mg once per week initially, and increased to 50 mg once per week if needed to improve A1C

30-mg and 50-mg pens for subcutaneous injection

$500


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed January 11, 2017).

SAFETY

As with other GLP-1 receptor agonists, use of albiglutide increases the risk of acute pancreatitis (0.3% with albiglutide vs. 0.1% with placebo).1 Although the risk of hypoglycemia is low (2% over one year) with albiglutide monotherapy, the risk increases when it is added to a sulfonylurea (13% over one year) or basal insulin (16% over six months).1 No dosage adjustment is needed in patients with renal dysfunction, although albiglutide should not be used in patients with end-stage renal disease.6 Renal failure has been reported in dehydrated patients. As with several other GLP-1 receptor agonists, albiglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma, and in patients with multiple endocrine neoplasia syndrome type 2.1 Albiglutide is a U.S. Food and Drug Administration pregnancy category C drug and has not been evaluated in breastfeeding women.1

TOLERABILITY

Overall, albiglutide is well tolerated, with adverse effect rates similar to placebo. Gastrointestinal symptoms, including nausea, vomiting, diarrhea, constipation, and acid reflux, are the most common adverse effects (39% with albiglutide vs. 33% with placebo) and are most often mild.1 Injection site reactions are also more

Address correspondence to Gregory Trietley, PharmD, BCPS, at gregory.trietley@ahn.org. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

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1. U.S. National Library of Medicine. DailyMed. Label: Tanzeum - albiglutide injection, powder, lyophilized, for solution. Updated September 13, 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fcad939-76e7-49cf-af94-4e6aef17901f. Accessed October 18, 2016....

2. Reusch J, Stewart MW, Perkins CM, et al. Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin. Diabetes Obes Metab. 2014;16(12):1257–1264.

3. Ahrén B, Johnson SL, Stewart M, et al. HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes Care. 2014;37(8):2141–2148.

4. Weissman PN, Carr MC, Ye J, et al. HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea. Diabetologia. 2014;57(12):2475–2484.

5. Home PD, Shamanna P, Stewart M, et al. Efficacy and tolerability of albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5. Diabetes Obes Metab. 2015;17(2):179–187.

6. Center for Drug Evaluation and Research. Albiglutide clinical review. 2013. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000MedR.pdf. Accessed September 4, 2016.

7. Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study [published correction appears in Lancet Diabetes Endocrinol. 2014;2(3):e5]. Lancet Diabetes Endocrinol. 2014;2(4):289–297.

8. Leiter LA, Carr MC, Stewart M, et al. Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus sitagliptin in patients with type 2 diabetes and renal impairment: a randomized phase III study. Diabetes Care. 2014;37(10):2723–2730.

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, Contributing Editor.

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

 

 

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