A recent study published in JAMA evaluated the effectiveness of oral glucose-lowering agents, including metformin and glyburide, in preventing large-for-gestational-age (LGA) infants in individuals with gestational diabetes. This randomized trial aimed to compare the use of these oral medications with insulin, the traditional treatment for managing gestational diabetes.
Gestational diabetes has traditionally been treated with insulin, which helps control blood sugar levels and reduces the risk of perinatal complications. In recent years, oral glucose-lowering agents such as metformin and glyburide have gained attention due to their easier administration and cost-effectiveness. Despite their growing popularity, concerns about their safety, especially regarding placental transfer and long-term effects on offspring, have raised questions about their non-inferiority to insulin.
The study, conducted across 25 centers in the Netherlands, involved pregnant individuals aged 18 and older with singleton pregnancies between 16 and 34 weeks of gestation. These participants had not achieved glycemic control after two weeks of dietary intervention. Participants who met the inclusion criteria, which involved fasting glucose levels higher than 95 mg/dL or elevated postprandial glucose levels, were randomly assigned to receive either oral glucose-lowering agents or insulin.
The oral agents group received metformin and glyburide, while insulin-treated individuals received insulin based on local clinical practices. The study’s primary outcome was the incidence of LGA infants, and secondary outcomes included maternal and neonatal health indicators, including cesarean delivery rates, hypoglycemia, and preeclampsia.
From April 2017 to November 2022, 820 participants were randomized, with 409 assigned to the oral agents group and 411 to the insulin group. The results showed that 23.9% of infants in the oral agents group were born LGA, compared to 19.9% in the insulin group, with a non-significant difference of 4.0% (95% CI, -1.7% to 9.8%). This failure to meet the non-inferiority margin indicated that oral medications were less effective than insulin in preventing LGA infants.
Moreover, maternal hypoglycemia occurred more frequently in the oral agents group (20.9% vs. 10.9%), and adverse effects like nausea and diarrhea were more common in this group. Despite these challenges, participants in the oral agents group reported higher satisfaction with their treatment, suggesting that ease of use played a role in treatment preference.
The study concluded that oral glucose-lowering agents (metformin and glyburide) were not non-inferior to insulin in preventing LGA infants, as they failed to meet the non-inferiority margin. While these medications may reduce the need for insulin, they also resulted in a higher incidence of maternal hypoglycemia and other adverse effects.
The findings suggest that insulin remains the more effective treatment for preventing LGA infants in gestational diabetes. However, the study also highlights the potential for oral medications to offer benefits in terms of patient satisfaction and accessibility, though further research is necessary to optimize treatment strategies for gestational diabetes.
This trial emphasizes the importance of balancing treatment effectiveness with patient preferences and the need for further studies to explore combination therapies and safer alternatives to insulin.
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