Use of Sodium–Glucose Cotransporter 2 Inhibitors in Patients With Type 1 Diabetes and Rates of Diabetic Ketoacidosis
| Autor: | Yandong Qiang, Elizabeth C. Dee, Catherine A. Panozzo, Richard S. Swain, Christian Hampp, Casie Horgan, Judith C. Maro, Rong Chen Tilney, Sarah K. Dutcher, Andrew B. Petrone |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Research design medicine.medical_specialty Diabetic ketoacidosis Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism Diabetic Ketoacidosis 03 medical and health sciences 0302 clinical medicine Internal medicine Diabetes mellitus Prevalence Internal Medicine medicine Humans Hypoglycemic Agents In patient Glycosides 030212 general & internal medicine Sodium-Glucose Transporter 2 Inhibitors Advanced and Specialized Nursing Type 1 diabetes Errata business.industry Incidence Incidence (epidemiology) medicine.disease United States Clinical trial Diabetes Mellitus Type 1 Sodium/Glucose Cotransporter 2 Female business Algorithms |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| Popis: | OBJECTIVE To estimate real-world off-label use of sodium–glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and compare them with DKA rates observed in sotagliflozin clinical trials. RESEARCH DESIGN AND METHODS We identified initiators of SGLT2 inhibitors in the Sentinel System from March 2013 to June 2018, determined the prevalence of type 1 diabetes using a narrow and a broad definition, and measured rates of DKA using administrative claims data. Standardized incidence ratios (SIRs) were calculated using age- and sex-specific follow-up time in Sentinel and age- and sex-specific DKA rates from sotagliflozin trials 309, 310, and 312. RESULTS Among 475,527 initiators of SGLT2 inhibitors, 0.50% and 0.92% met narrow and broad criteria for type 1 diabetes, respectively. Rates of DKA in the narrow and broad groups were 7.1/100 person-years and 4.3/100 person-years, respectively. Among patients who met narrow criteria for type 1 diabetes, rates of DKA were highest for patients aged 25–44 years, especially females aged 25–44 years (19.7/100 person-years). More DKA events were observed during off-label use of SGLT2 inhibitors in Sentinel than would be expected based on sotagliflozin clinical trials (SIR = 1.83; 95% CI 1.45–2.28). CONCLUSIONS Real-world off-label use of SGLT2 inhibitors among patients with type 1 diabetes accounted for a small proportion of overall SGLT2 inhibitor use. However, the risk for DKA during off-label use was notable, especially among young, female patients. Although real-word rates of DKA exceeded the expectation based on clinical trials, results should be interpreted with caution due to differences in study methods, patient samples, and study drugs. |
| Databáze: | OpenAIRE |
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