STEPS

New Drug Reviews

Lixisenatide (Adlyxin) for Type 2 Diabetes Mellitus

 

Am Fam Physician. 2017 Aug 15;96(4):257-258.

Lixisenatide (Adlyxin) 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*

Lixisenatide (Adlyxin)

10 mcg once daily for 14 days, then increase to 20 mcg daily

10-mcg and 20-mcg pens for subcutaneous injection

$595 for 20-mcg daily dosage


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed May 31, 2017).

DrugDosageDose formCost*

Lixisenatide (Adlyxin)

10 mcg once daily for 14 days, then increase to 20 mcg daily

10-mcg and 20-mcg pens for subcutaneous injection

$595 for 20-mcg daily dosage


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed May 31, 2017).

SAFETY

Lixisenatide is not recommended for patients with type 1 diabetes, a history of chronic or unexplained pancreatitis, diabetic ketoacidosis, gastroparesis, or end-stage renal disease.1 Acute pancreatitis has been reported with the use of other GLP-1 receptor agonists and in initial studies of lixisenatide.1 Adverse effects increase with poor renal function, and lixisenatide labeling recommends against use by patients with an estimated glomerular filtration rate less than 15 mL per minute per 1.73 m2.1 Patients with an estimated glomerular filtration rate less than 60 mL per minute per 1.73 m2 should be monitored closely for gastrointestinal and hypoglycemic adverse events.1

Adverse effects of lixisenatide are similar to those of other GLP-1 receptor agonists.1 Severe symptomatic hypoglycemia, defined as an event requiring assistance or medical intervention, or with a serum blood glucose level less than 36 mg per dL (2.0 mmol per L), occurred in less than 1% of patients using lixisenatide over a 12- to 24-week period.1 The risk of symptomatic hypoglycemia, defined as clinical symptoms resulting from a plasma glucose level less than 60 mg per dL (3.3 mmol per L), increases significantly when lixisenatide is combined with basal insulin with or without a sulfonylurea (47% vs. 22%; number needed to harm [NNH] = 4). Symptomatic hypoglycemia occurs less frequently when lixisenatide is combined with metformin alone (1% vs. 3%; NNH = 50). Lixisenatide does not appear to increase the risk of cardiovascular morbidity or mortality over two years when used in adults with type 2 diabetes following a recent acute coronary event.2 Lixisenatide has not been studied in pregnant women, and it is unknown whether it is excreted in breast milk.1

TOLERABILITY

Gastroin

Address correspondence to Valerie Niedermier, MD, at v.niedermier@gmail.com. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

show all references

1. DailyMed. Drug label information: Adlyxin—lixisenatide injection, solution. https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1727cc16-4f86-4f13-b8b5-804d4984fa8c. Accessed March 30, 2017....

2. Pfeffer MA, Claggett B, Diaz R, et al.; ELIXA Investigators. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015;373(23): 2247–2257.

3. Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012;35(6):1225–1231.

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

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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