GLP-1, SGLT2 prescriptions for type 1 diabetes rising despite no regulatory approval
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Key takeaways:
- Prescriptions for GLP-1 receptor agonists and SGLT2 inhibitors are increasing for patients with type 1 diabetes.
- Those drug classes are not approved for commercial use for patients with type 1 diabetes.
Prescriptions for GLP-1 receptor agonists and SGLT2 inhibitors for patients with type 1 diabetes rose between 2010 and 2023 despite not being approved for that population, according to a research letter published in JAMA.
“Concerns about euglycemic diabetic ketoacidosis led to the removal of SGLT2 inhibitors for type 1 diabetes in Europe, and the U.S. Food and Drug Administration has not approved their use in type 1 diabetes. Concerns exist about GLP-1 receptor agonists causing substantial weight loss and increasing the risk of ketoacidosis or hypoglycemia,” Hui Shao, MD, PhD, associate professor in the Hubert department of global health and Emory Global Diabetes Research Center at Emory University Rollins School of Public Health, and colleagues wrote. “However, use of these newer medications in type 1 diabetes may continue due to the significant weight management and cardiorenal benefits observed in people with and without type 2 diabetes.”
Shao and colleagues conducted a pooled cross-sectional analysis using electronic health records from Epic Cosmos.
Off-label usage
“Our observation of increased prescription of SGLT2 and GLP-1 in the pursuit of cardiovascular merits and weight control in type 1 diabetes in daily practice and its off-label nature in this population prompted us to conduct this surveillance study,” Shao told Healio.
The analysis of the type 1 diabetes population between 2010 — the introduction of the first GLP-1 receptor agonist, liraglutide (Saxenda, Novo Nordisk) — and 2023 included 943,456 patients. An analysis of those prescribed GLP-1 receptor agonists or SGLT2 inhibitors vs. the overall type 1 diabetes population in 2023 included 405,019 patients in the overall population (mean age, 41.5 years; 49.5% women), 18,725 patients newly prescribed GLP-1 receptor agonists (mean age, 47.1 years; 63.2% women) and 7,210 patients newly prescribed SGLT2 inhibitors (mean age, 56.8 years; 44.7% women).
Compared with the overall type 1 diabetes population, those newly prescribed SGLT2 inhibitors had higher rates of myocardial infarction, stroke, heart failure, ischemic heart disease, obesity, retinopathy, neuropathy and nephropathy (P for all < .001), whereas those newly prescribed GLP-1 receptor agonists had higher rates of obesity (P < .001) but lower or similar rates of the other conditions, the researchers found.
Those newly prescribed SGLT2 inhibitors had higher rates of heart and kidney conditions than those newly prescribed GLP-1 receptor agonists (eg, heart failure, 16.6% vs. 2.6%; chronic kidney disease, 26.9% vs. 15.9%) but lower rates of obesity (45.7% vs. 69.4%), Shao and colleagues wrote.
The percentage of patients with type 1 diabetes prescribed a GLP-1 receptor agonist rose from 0.3% in 2010 to 6.6% in 2023, whereas the percentage of patients with type 1 diabetes prescribed an SGLT2 inhibitor rose from 0.1% to 2.4%, and the percentage of patients with type 1 diabetes prescribed either rose from 0.7% to 8.3% (P for trend for all < .001), the researchers wrote.
The greatest growth among GLP-1 receptor agonists in prescriptions for patients with type 1 diabetes occurred with semaglutide (Ozempic/Rybelsus/Wegovy, Novo Nordisk), which rose from 0.2% in 2018 to 4.4% in 2023, whereas tirzepatide (Mounjaro/Zepbound, Eli Lilly) was prescribed in 1.3% of patients with type 1 diabetes in 2023 after being introduced in 2022.
The greatest increase in SGLT2 prescriptions over time occurred in patients with cardiovascular disease, and the greatest increase in GLP-1 prescriptions over time occurred in patients with obesity, Shao and colleagues wrote.
Safety information not known
“While the rates were not surprising, they are concerning,” Shao told Healio. “The observed trends align with what we see in daily clinical practice. However, the safety of these treatments in the type 1 diabetes population is not yet well understood. Our team has received federal funding to investigate the safety of SGLT2 inhibitors and GLP-1 receptor agonists in the type 1 diabetes population. Through this study, we aim to identify specific subpopulations where these medications may be safe to use.”
For more information:
Hui Shao, MD, PhD, can be reached at hui.shao@emory.edu.
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