Details
In this analysis, we performed signal identification for prucalopride and plecanatide by monitoring non-pregnancy and non-cancer outcomes among new users of prucalopride and plecanatide in the Sentinel Distributed Database (SDD).
We conducted this signal identification assessment using an active‑comparator, new‑user design to identify incident outcomes following initiation of prucalopride or plecanatide using TreeScan analyses among individuals 18 years of age and older. Analyses were conducted bidirectionally, with prucalopride and plecanatide alternating roles as the exposure and active comparator. We conducted a Type 2 analysis using the Cohort Identification and Descriptive Analysis (CIDA) module, version 14.3.1, with the Propensity Score Analysis and Signal Identification modules.
The study period includes data from April 19, 2019 to May 31, 2025. We distributed this request to 13 Sentinel Data Partners (DP) on January, 29, 2026. We included data from six DPs where the propensity score models converged. The DPs that were not included in the analysis lacked sufficient exposures to ensure propensity score model convergence.
Statistical alerts generated by this analysis do not on their own represent safety signals. Alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.