14 Nov Utilization of Antidiabetic Drugs During Pregnancy: A CDM Pilot Project
Posted at 10:18h
in
Utilization of Antidiabetic Drugs During Pregnancy: A CDM Pilot Project
HC0083_OS007_CDM
Overview
WHAT IS THE ISSUE?
- The prevalence of diabetes and GDM have increased over the past 2 decades, leading to increasing exposure to ADDs during pregnancy.
- The Food and Drug Administration Sentinel Initiative recently published a study describing the use of antidiabetic drugs across the US, however, the use in Canada is unkown.
WHAT WAS THE AIM OF THE STUDY?
- The objective of this project is to document the utilization of ADD among pregnant persons in Canada using data transformed into the Sentinel CDM.
Specifically, we aimed to:
• describe the baseline characteristics of pregnant persons at the time of conception
• describe the prevalence of use of specific ADDs overall and according to maternal characteristics and over time.
HOW WAS THE STUDY CONDUCTED?
- We conducted a cohort study in 3 Canadian provinces (Manitoba, Ontario and Saskatchewan) to demonstrate the feasibility of replicating a US FDA Sentinel study of ADD use during pregnancy. We used Canadian data that were transformed into the Sentinel Common Data Model (CDM).
- Three cohorts were constructed from pregnant persons aged 10-54 years, with a hospital discharge record of stillbirth or live birth between January 1, 2012 and December 31, 2022. Cohort 1: live birth and still birth pregnancies; Cohort 2: persons with pre-existing diabetes; Cohort 3: persons without pre-existing diabetes and with GDM.
- Characteristics, including presence of ADD claims before pregnancy, at any time during pregnancy and by trimester, overall and stratified by maternal age, and calendar year.
WHAT DID THE STUDY FIND?
- We identified 249,063 unique live birth or stillbirth pregnancy episodes among 166,529 unique individuals. In total, 3,308 individuals (2.0%) had pre-existing diabetes and 21,031 individuals (12.6%) had GDM without pre-existing diabetes.
- Overall, 3.8% of pregnancies were exposed to insulin, 3.1% to metformin, and 0.3% to a sulfonylurea at some point during pregnancy. Insulin use increased as pregnancies progressed, rising from 1.3% in the first trimester to 3.7% in the third trimester. ADD use also increased with maternal age and over the course of the study period.
- Among the 4,058 pregnancy episodes in persons with pre-existing diabetes, 86% were exposed to insulin at some point during pregnancy, 50.4% to metformin, and 15.4% to a sulfonylurea. While the use of insulin rose sharply throughout pregnancy, the use of other ADDs remained stable. The number of people taking metformin and sulfonylureas increased with maternal age, but insulin use stayed high (85% to 88%) across all age groups.
- Among the 24,448 pregnancy episodes in persons without pre-existing diabetes but with GDM, insulin (23.4%) and metformin (18.9%) were the most common medications used during pregnancy, with little variation across maternal age. The use of both medications increased sharply throughout pregnancy and over the study period.
IMPLICATIONS
- We successfully demonstrated the feasibility of replicating the FDA Sentinel analysis using Canadian data transformed into the Sentinel CDM.
- Our findings confirm that a growing percentage of pregnancies are being exposed to ADDs in Canada, including to newer therapies for which there are limited safety data. This highlights the importance of ongoing surveillance and targeted studies of the real-world use and safety of ADDs during pregnancy.
KEY MESSAGES
- Our findings confirm that a growing percentage of pregnancies are exposed to ADDs in Canada. This highlights the importance of ongoing surveillance of the real-world use and safety of ADDs during pregnancy.