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<p>As prescribing of newer antihyperglycemic agents expands, there remains limited comparative safety data for older adults—a population particularly vulnerable to adverse drug events and underrepresented in clinical trials. We conduct a multinational cohort study using nine databases from the U.S. and Europe. Among adults aged ≥65, we compare eighteen safety outcomes across four classes of second-line antihyperglycemic agents. We use propensity score adjustment, empirical calibration, and prespecified diagnostics and estimated hazard ratios. In a cohort of 1.8 million, both GLP-1 receptor agonists and SGLT2 inhibitors are linked to significantly lower risks of hypoglycemia and hyperkalemia than sulfonylureas. GLP-1 receptor agonists show lower risks of peripheral edema than DPP-4 inhibitors. However, SGLT2 inhibitors are associated with a higher risk of diabetic ketoacidosis compared to GLP-1 receptor agonists and sulfonylureas. These results support informed, safety-conscious prescribing in the older adults underrepresented in clinical trials yet highly susceptible to adverse events.</p>

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Real-world evidence for comparative safety of second-line antihyperglycemic agents in older adults with type 2 diabetes

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月4日

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  • Chungsoo Kim,
  • Fan Bu,
  • Clair Blacketer,
  • Anna Ostropolets,
  • Talita Duarte-Salles,
  • Benjamin Viernes,
  • Thomas Falconer,
  • Andrea Pistillo,
  • Jing Li,
  • Can Yin,
  • Mui Van Zandt,
  • Paul Nagy,
  • Akihiko Nishimura,
  • Evan Minty,
  • Seng Chan You,
  • Mitsuaki Sawano,
  • Shoko Sawano,
  • Ja Young Jeon,
  • Arya Aminorroaya,
  • Lovedeep S. Dhingra,
  • Aline F. Pedroso,
  • Phyllis Thangaraj,
  • David A. Dorr,
  • Nicole Pratt,
  • Kenneth K. C. Man,
  • Wallis C. Y. Lau,
  • Daniel R. Morales,
  • Rohan Khera,
  • Martijn J. Schuemie,
  • Patrick B. Ryan,
  • George Hripcsak,
  • Harlan M. Krumholz,
  • Marc A. Suchard,
  • Yuan Lu

摘要

As prescribing of newer antihyperglycemic agents expands, there remains limited comparative safety data for older adults—a population particularly vulnerable to adverse drug events and underrepresented in clinical trials. We conduct a multinational cohort study using nine databases from the U.S. and Europe. Among adults aged ≥65, we compare eighteen safety outcomes across four classes of second-line antihyperglycemic agents. We use propensity score adjustment, empirical calibration, and prespecified diagnostics and estimated hazard ratios. In a cohort of 1.8 million, both GLP-1 receptor agonists and SGLT2 inhibitors are linked to significantly lower risks of hypoglycemia and hyperkalemia than sulfonylureas. GLP-1 receptor agonists show lower risks of peripheral edema than DPP-4 inhibitors. However, SGLT2 inhibitors are associated with a higher risk of diabetic ketoacidosis compared to GLP-1 receptor agonists and sulfonylureas. These results support informed, safety-conscious prescribing in the older adults underrepresented in clinical trials yet highly susceptible to adverse events.