sk yourself these two questions: What if there was another GLP-1 receptor agonist on the market? If so, what information would you know about it?
In August 2016, the Food and Drug Administration (FDA) may be determining if lixisenatide (Lyxumia) will be the newest GLP-1 receptor agonist approved for the market and clinical practice in the United States. In addition, the FDA would be reviewing the new drug application for the fixed-drug combination product of lixisenatide and insulin glargine. In this post, I wanted to provide some basic information regarding lixisenatide.
Here are some quick facts:
|Pharmacokinetics || |
Peak: 1 to 2 hours
Half life: 2 to 4 hours
|Dosing || |
Initial: 10 or 20 micrograms subcutaneously once daily x 14 days
Maintenance: 20 micrograms subcutaneously once daily[1 or 2-step titration]
|Administration || |
Inject within 1 hour of a meal, recommended as the same meal every day.
|Adverse Events || |
Its safety profile is similar to other GLP-1 receptor agonists.
Gastrointestinal adverse events, particularly nausea, are the most common and typically mild and transient.
|Potential Role || |
Among patients uncontrolled glycemic levels who need post-prandial control or patients on bolus insulin, who need additional glycemic control and weight loss (replacement to lixisenatide and insulin glargine product)
So, what is the evidence with lixisenatide? The efficacy and safety of this once daily GLP-1 receptor agonist has been investigated through the GetGoal program, as either monotherapy or an add-on therapy to oral agents (e.g., metformin, pioglitazone) and insulin. For head-to-head studies, lixisenatide was compared to exenatide (Byetta) and insulin glulisine (Apidra). In addition, lixisenatide has been studied among diverse patient populations, including the Asian population and high-risk cardiovascular patients.
In the GetGoal program, the overall reduction in hemoglobin A1c concentrations with lixisenatide was 0.73 to 1.0, over a time period of 12 to 24 weeks. GLP-1 receptor agonists are commonly used for their potential to promote weight loss, which varied with lixisenatide from 0.2 to 2 kilograms in the clinical trials. In 2015, the ELIXA study was published in New England Journal of Medicine regarding the safety of lixisenatide among patients with type 2 diabetes and an acute coronary event within 180 days. As a quick summary of the trial, lixisenatide did not increase nor prevent the number of events – death from cardiovascular causes, nonfatal stroke, nonfatal myocardial infarction or unstable angina. Overall, the effect of lixisenatide among high-risk cardiovascular patients was neutral, when compared to placebo. Please check out the full article and results of the ELIXA study.
I hope this blog served as a quick read to increase your knowledge about lixisenatide, as it may be the newest GLP-1 receptor agonist approved by the FDA. Please share your thoughts about another GLP-1 receptor agonist potentially on the market and for clinical practice.
*Update: As of July 28, 2016, the FDA approved the GLP-1 receptor agonist lixisenatide under the brand name ADLYXIN.
About the Author
Jennifer Clements received her Doctorate of Pharmacy from Campbell University in 2006 and completed a primary care residency at a Veterans Affairs Medical Center in 2007. She is also a certified diabetes educator and board certified in pharmacotherapy. Currently, she is the Interim Chair and Associate Professor in the Department of Pharmacy Practice at Presbyterian College School of Pharmacy.