Use of Antidiabetic drugs during pregnancy among U.S. women with Livebirth deliveries in the Mini-Sentinel system

Katrina Mott,Katherine Haffenreffer,Susan E Andrade,Sengwee Toh,Marsha E Reichman,Caren Kieswetter

doi:10.1186/s12884-019-2609-8

Abstract

BackgroundAs the prevalence of diabetes mellitus increases in the population, the exposure to antidiabetic drugs (ADDs) during pregnancies is expected to grow, as has been seen over the last decade. The objective of this study was to estimate the prevalence of ADD use during pregnancy among women in the Mini-Sentinel Distributed Database (MSDD) who delivered a liveborn infant.MethodsWe identified qualifying livebirth pregnancies among women aged 10 to 54 years in the MSDD from 2001 to 2013. ADD use was estimated using outpatient pharmacy dispensing claims and days-supplied among three cohorts: all livebirth pregnancies, pregnancies among women with pre-existing diabetes, and pregnancies among women without prior ADD use.ResultsAmong the 1.9 million pregnancies in the MSDD that resulted in a livebirth from 2001 to 2013, 4.4% were exposed to an ADD. Of the 15,606 pregnancies (0.8%) with pre-existing diabetes, 92.8% were also exposed during the pregnancy period. The most commonly used product in these pregnancies was insulin (75.6% of pregnancies). In contrast, in pregnancies of women without prior ADD use, the most commonly used products were glyburide and insulin, and most of these users were diagnosed with gestational diabetes.ConclusionsPatterns of ADD use during pregnancy described here, along with changes in disease incidence and management, highlight the importance of continuing surveillance of ADD utilization patterns and examining the safety and effectiveness of these products in pregnancy.

Highlights

There is a need for ongoing routine surveillance of medication use during pregnancy, as new drugs become available and prescribing trends and recommendations change
To estimate the trends of antidiabetic drug (ADD) use for gestational diabetes, we identified pregnancies in the third cohort as women who were dispensed an ADD during the pregnancy period, and who met the following definition of gestational diabetes: a diagnosis code for gestational diabetes (ICD9-CM 648.8) in the 2nd or 3rd trimester and no prior diabetes mellitus diagnosis
In the Mini-Sentinel Distributed Database (MSDD) cohort of livebirth pregnancies from 2001 to 2013, 4.4% were exposed to an ADD during pregnancy

Summary

Introduction

There is a need for ongoing routine surveillance of medication use during pregnancy, as new drugs become available and prescribing trends and recommendations change. The American Congress of Obstetricians and Gynecologists (ACOG) Practice Bulletin #30 in 2001 recommended adding insulin if glycemic control could not be achieved with nutritional therapy alone for women with gestational diabetes [8]. In 2013, the ACOG guidelines were revised (Practice Bulletin #137) to state that insulin and oral ADDs (e.g., glyburide and metformin) are efficacious, and could be considered for first-line therapy [9]. The American Diabetes Association guidelines (2015) lists insulin and metformin as preferred treatments, and states that glyburide may be used, but may have a higher rate of neonatal hypoglycemia and macrosomia [10]. As the prevalence of diabetes mellitus increases in the population, the exposure to antidiabetic drugs (ADDs) during pregnancies is expected to grow, as has been seen over the last decade. The objective of this study was to estimate the prevalence of ADD use during pregnancy among women in the Mini-Sentinel Distributed Database (MSDD) who delivered a liveborn infant

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Discussion

Conclusion