Characterization of SGLT-2 Inhibitor Users in the Patient-Centered Clinical Research Network (PCORnet)

Project Title Characterization of SGLT-2 Inhibitor Users in the Patient-Centered Clinical Research Network (PCORnet)
Date Posted
Thursday, March 19, 2020
Project ID
fda_pmp_wp001
Status
Complete
Deliverables
Related Links
Description

The objective of this request was to assess the feasibility of using national Patient-Centered Clinical Research Network (PCORnet) data to complement results from queries run against the Sentinel Distributed Database (SDD). PCORnet is comprised of electronic health record data. This request aims to describe the demographic, vital, and clinical characteristics of patients receiving a prescription for sodium-glucose cotransporter-2 (SGLT-2) inhibitors and other select anti-diabetic medications.

We used a retrospective study design to identify prevalent users of SGLT-2 inhibitors or sitagliptin within the PCORnet network between March 1, 2013, and June 30, 2018. We included data from 25 PCORnet Data Marts in this report. We distributed this request on October 2, 2019.

Medical Product
sitagliptin
sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Population / Cohort
All individuals
Time Period
March 1, 2013 - June 30, 2018
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Patient-Centered Clinical Research Network (PCORnet)
FDA Center
CDER