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<p>The FDA Sentinel Real-World Evidence Data Enterprise (RWE-DE) contains linked electronic health records with claims data for over 25 million patients. To demonstrate the applicability of the RWE-DE to a study previously considered infeasible in claims-based Sentinel network, we emulated a target trial using a case study comparing acute pancreatitis among new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) with new users of dipeptidyl peptidase-4 inhibitors (DPP-4i) among 97,119 patients with type 2 diabetes mellitus from HealthVerity [2018–2020] and TriNetX [2013–2024] databases. We applied a previously validated computable phenotyping algorithm using EHRs to identify acute pancreatitis as the primary outcome. After confounding adjustment for &gt;135 variables using propensity score fine stratification weighting, the hazard ratio (95% confidence interval) for acute pancreatitis following SGLT-2i initiation compared to DPP-4i initiation was 0.85 (0.67–1.07) for intent-to-treat and 0.84 (0.58–1.22) for per-protocol analysis. This study serves as a proof-of-concept for future safety assessments in Sentinel.</p>

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Strengthening inferential studies in the FDA Sentinel initiative: results from a methodological demonstration project

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月15日

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  • Rishi J. Desai,
  • Janick Weberpals,
  • Haritha Pillai,
  • Adebola Ajao,
  • Mukund Desibhatla,
  • Rebecca Hawrusik,
  • José J. Hernández-Muñoz,
  • Chanelle Jones,
  • Jamal T. Jones,
  • Joyce Lii,
  • Jie Li,
  • Jennifer G. Lyons,
  • Ryan Schoeplein,
  • Fatma M. Shebl,
  • Sengwee Toh,
  • Elisabetta Patorno,
  • Sebastian Schneeweiss

摘要

The FDA Sentinel Real-World Evidence Data Enterprise (RWE-DE) contains linked electronic health records with claims data for over 25 million patients. To demonstrate the applicability of the RWE-DE to a study previously considered infeasible in claims-based Sentinel network, we emulated a target trial using a case study comparing acute pancreatitis among new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) with new users of dipeptidyl peptidase-4 inhibitors (DPP-4i) among 97,119 patients with type 2 diabetes mellitus from HealthVerity [2018–2020] and TriNetX [2013–2024] databases. We applied a previously validated computable phenotyping algorithm using EHRs to identify acute pancreatitis as the primary outcome. After confounding adjustment for >135 variables using propensity score fine stratification weighting, the hazard ratio (95% confidence interval) for acute pancreatitis following SGLT-2i initiation compared to DPP-4i initiation was 0.85 (0.67–1.07) for intent-to-treat and 0.84 (0.58–1.22) for per-protocol analysis. This study serves as a proof-of-concept for future safety assessments in Sentinel.