30 Oct Safety Monitoring During Use of Ozempic in People with Diabetes: A CDM Pilot Project
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Safety Monitoring During Use of Ozempic in People with Diabetes: A CDM Pilot Project
OS0005_CDM
Overview
WHAT IS THE ISSUE?
- Semaglitude is used to improve glucose control in adults with type 2 diabetes (T2DM).
- A study conducted by the FDA compared Ozempic to sitagliptin for treating T2DM and found that the incidence of gastrointestinal adverse events was higher in semaglitude.
- As Ozempic use increases in people with diabetes, there is a need for real-safety outcome monitoring in Canada.
WHAT WAS THE AIM OF THE STUDY?
- The purpose of this project was to explore the feasibility of replicating signal identification analyses in Canada with the FDA Sentinel signal-detection analysis using the TreeScan tool.
- Specifically, the objective was to determine whether there are potential safety signals for Ozempic during the treatment of adults with diabetes using TreeScan.
HOW WAS THE STUDY CONDUCTED?
- We conducted a population-based cohort study using administrative health databases from 4 provinces (British Columbia, Manitoba, Ontario, and Saskatchewan) of adults with diabetes who were newly treated with Ozempic or sitagliptin.
- We replicated the US FDA Sentinel TreeScan signal-detection analysis using Ozempic as the case study.
What did the study find?
- We identified 92,428 new users of Ozempic and 46,266 new users of sitagliptin with T2DM.
- New users of Ozempic (compared to new users of sitagliptin), were:
- relatively younger,
- less likely to have Alzheimer disease and other dementias,
- more likely to have high blood cholesterol and depressive disorder, more likely to be living with obesity, and much more likely to be co-prescribed insulin
- followed for a median of 43 days compared to 103 days for new users of sitagliptin.
- In comparing Ozempic to sitagliptin the potential safety concerns identified included nausea, vomiting, obesity, polyneuropathy (damage to nerves outside of the brain and spinal cord), and other nervous system disorders. However, none were identified as signals of increased risk.
Implications
- Although the analysis identified potential safety concerns, this study alone does not establish or confirm safety signals for Ozempic, and further focused studies are necessary.
- This study is the first of its kind to demonstrate the feasibility of replicating a US FDA Sentinel TreeScan analysis with Canadian data, providing important insights for future studies.
Key messages
- Further focused studies are necessary to establish the presence of meaningful safety signals of Ozempic.
- Our study provides important lessons for the future use of Canadian data in TreeScan-based analyses.