Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar 1;5(3):e225026.
doi: 10.1001/jamanetworkopen.2022.5026.

Association of Glyburide and Subcutaneous Insulin With Perinatal Complications Among Women With Gestational Diabetes

Monique M Hedderson  1   2 , Sylvia E Badon  1 , Noel Pimentel  1 , Fei Xu  1 , Anne Regenstein  3 , Assiamira Ferrara  1 , Romain Neugebauer  1
Affiliations

Association of Glyburide and Subcutaneous Insulin With Perinatal Complications Among Women With Gestational Diabetes

Monique M Hedderson et al. JAMA Netw Open. .

Erratum in

Abstract

Importance: Nearly 30% of individuals with gestational diabetes (GDM) do not achieve glycemic control with lifestyle modification alone and require medication treatment. Oral agents, such as glyburide, have several advantages over insulin for the treatment of GDM, including greater patient acceptance; however, the effectiveness of glyburide for the treatment of GDM remains controversial.

Objective: To compare the perinatal and neonatal outcomes associated with glyburide vs insulin using causal inference methods in a clinical setting with information on glycemic control.

Design, setting, and participants: The population-based cohort study included patients with GDM who required medication treatment from 2007 to 2017 in Kaiser Permanente Northern California. Machine learning and rigorous casual inference methods with time-varying exposures were used to evaluate associations of exposure to glyburide vs insulin with perinatal outcomes. Data analysis was conducted from March 2018 to July 2017.

Exposures: Time-varying exposure to glyburide vs insulin during pregnancy.

Main outcomes and measures: Outcomes evaluated separately included neonatal hypoglycemia, jaundice, shoulder dystocia, respiratory distress syndrome (RDS), neonatal intensive care unit (NICU) admission, size-for-gestational age, and cesarean delivery. Inverse probability weighting (IPW) estimation was used to separately compare perinatal outcomes between those initiating glyburide and insulin. This approach was combined with Super Learning for propensity score estimation to account for both baseline and time-dependent confounding in both per-protocol (primary) and intention-to-treat (secondary) analyses to evaluate sustained exposure to the same therapy.

Results: From 2007 to 2017, 11 321 patients with GDM (mean [SD] age, 32.9 [4.9] years) initiated glyburide or insulin during pregnancy. In multivariate models, the risk of neonatal respiratory distress was 2.03 (95% CI, 0.13-3.92) per 100 births lower and the risk of NICU admission was 3.32 (95% CI, 0.20-6.45) per 100 births lower after continuous exposure to glyburide compared with insulin. There were no statistically significant differences in glyburide vs insulin initiation in risk for neonatal hypoglycemia (0.85 [95% CI, -1.17 to 2.86] per 100 births), jaundice (0.02 [95% CI, -1.46 to 1.51] per 100 births), shoulder dystocia (-1.05 [95% CI, -2.71 to 0.62] per 100 births), or large-for-gestational age categories (-2.75 [95% CI, -6.31 to 0.80] per 100 births).

Conclusions and relevance: Using data from a clinical setting and contemporary causal inference methods, our findings do not provide evidence of a difference in the outcomes examined between patients with GDM initiating glyburide compared with those initiating insulin.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Drs Neugebauer and Hedderson reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases during the conduct of the study. No other disclosures were reported.

Figures

Figure.
Figure.. Analytic Cohort Creation for Comparison of Glyburide vs Insulin Treatment on Subsequent Perinatal Outcomes
GDM indicates gestational diabetes.
See this image and copyright information in PMC

References

    1. DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014;11:130415. doi:10.5888/pcd11.130415 - DOI - PMC - PubMed
    1. Wendland EM, Torloni MR, Falavigna M, et al. . Gestational diabetes and pregnancy outcomes—a systematic review of the World Health Organization (WHO) and the International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria. BMC Pregnancy Childbirth. 2012;12:23. doi:10.1186/1471-2393-12-23 - DOI - PMC - PubMed
    1. Langer O, Yogev Y, Most O, Xenakis EM. Gestational diabetes: the consequences of not treating. Am J Obstet Gynecol. 2005;192(4):989-997. doi:10.1016/j.ajog.2004.11.039 - DOI - PubMed
    1. Langer O. Management of gestational diabetes: pharmacologic treatment options and glycemic control. Endocrinol Metab Clin North Am. 2006;35(1):53-78, vi. doi:10.1016/j.ecl.2005.09.007 - DOI - PubMed
    1. Bulletins-Obstetrics CoP . Practice Bulletin No. 137: gestational diabetes mellitus. Obstet Gynecol. 2013;122(2 Pt 1):406-416. - PubMed

Publication types