Study Reveals Surge in Off-Label Use of GLP-1 Agonists for Weight Loss

Over the last few years, the use of glucagon-like peptide-1 receptor agonists (GLP-1 agonists) for managing type 2 diabetes has dramatically increased. This is mainly because of the reported weight loss side effect that many people experience when on these medications. 

While GLP-1 medications Zepbound and Wegovy have received Food and Drug Administration (FDA) approval for weight loss in people with obesity, many are using other GLP-1 drugs, such as Ozempic, for weight loss off label. 

This rapid increase in users of GLP-1 drugs has caused worldwide shortages of these medications for people with type 2 diabetes who need them. 

Now, a new study published in Annals of Internal Medicine, reports that among the approximately 1 million new GLP-1 medication users identified between 2011 to 2023, there was a twofold increase in GLP-1 medication users who do not have type 2 diabetes but do have a body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, and in people with a BMI of 27 to 30 kg/m2 and an obesity-related comorbid condition. 

The researchers also found that the proportion of users of GLP-1 medications without FDA-approved indications rose from 0.21% in 2019 to 0.37% in 2023.For this population-based study, researchers used medical records from about 45 million people in the United States listed in the TriNetX real-time federated health research network who all had at least one outpatient or inpatient doctor visit between 2011 and 2023. 

Scientists accessed medical information for each study participant, including BMI, demographic data, diagnoses, and prescriptions. 

Upon analysis, researchers found there were about 1 million new users of GLP-1 medications between 2011 and 2023. 

While during this time frame the percentage of new users with type 2 diabetes decreased, there was a twofold increase in the proportions of users without type 2 diabetes and a BMI of 30 kg/m2 or greater, as well as in participants with a BMI of 27 to 30 kg/m2 and an obesity-related comorbid condition. 

Kevin Sheng-Kai Ma, DDS, FRSPH, FRSM, international scholar at the Center for Global Health at the Perelman School of Medicine at the University of Pennsylvania and lead author of this study, told Medical News Today that he and his colleagues were not surprised by these findings, as these [obesity and obesity-related issues are indications for GLP-1RA that have been approved in recent years. 

That said, clinicians are encouraged to monitor and continue assessing patients receiving GLP-1RA drugs.The researchers also discovered the quantity of GLP-1 medication users without FDA-approved indications increased from 0.21% in 2019 to 0.37% in 2023.This data suggests that more healthcare providers are seeing the benefits of these medications for treating obesity, which is a significant public health shift. 

Scientists also uncovered some gender and ethnic disparities in the use of GLP-1 medications.Researchers reported that between 2011 and 2023 the largest users of semaglutide were disproportionately female, non-Hispanic white.Health insurance companies and health plans vary greatly in how policies cover weight loss drugs.Even if a doctor prescribes this type of drug patients cannot obtain it if their insurance does not cover it, which could worsen disparities, especially for those with public insurance or in underserved populations. It is no secret that GLP-1 agonist medications like semaglutide — Ozempic, Wegovy — have demonstrated both effectiveness and popularity for treating obesity.

One consequence of this popularity is that despite their high cost, the GLP-1 agonist medications have seen demand outstrip their supply resulting in shortages making their availability to treat diabetes more limited. So, it is not surprising to see studies in medical journals documenting not only this increased demand, but also resulting shortages, and postulating on methods of obtaining these medications for those people who more desperately need them for diabetes than for weight loss. 

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