BMJ 2015;350:h1709 doi: 10.1136/bmj.h1709 (Published 31 March 2015)
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Research News
RESEARCH NEWS Use of glyburide to treat gestational diabetes is linked to adverse outcomes in babies, study finds Jacqui Wise London
Babies born to mothers treated with the sulfonylurea drug glyburide (glibenclamide) for gestational diabetes mellitus are more likely to experience adverse outcomes than those whose mothers are treated with insulin, research published in JAMA Pediatrics has found.1 Although the oral hypoglycaemic agent does not have marketing authorisation for use in pregnancy, it is used increasingly widely.
The retrospective cohort study found that glyburide was associated with a higher risk for newborns to be admitted to a neonatal intensive care unit, to have respiratory distress, hypoglycaemia, or birth injury, or to be large for their gestational age when compared with infants born to women treated with insulin.
About a 10th of women with gestational diabetes cannot achieve glucose control through routine care such as dietary measures, physical activity, and glucose monitoring. The standard therapy for women who need drug treatment is insulin, but oral agents are increasingly viewed as potential alternatives because of their easier administration, lower cost, and better acceptance. Several guideline bodies, including the American College of Obstetricians and Gynecologists and the UK National Institute for Health and Care Excellence, have endorsed the use of glyburide. However, other associations, such as the American Diabetes Association, have been more cautious. And a systematic review and meta-analysis published earlier this year in The BMJ concluded that glibenclamide was inferior to insulin and metformin and should not be used to treat women with gestational diabetes.2 This latest US study looked at outcomes in women with gestational diabetes by using data from an employer based insurance claims database from 2000 to 2011. Of 110 879 women with gestational diabetes, 8.3% were treated with glyburide (n=4982) or insulin (n=4193). The proportion of these women treated with glyburide increased from 8.5% in 2000 to 64.4% in 2011. Among infants born to mothers treated with glyburide the researchers found a 41% higher risk of admission to a neonatal intensive care unit (relative risk 1.41 (95% confidence interval 1.23 to 1.62)), a 63% higher risk of respiratory distress (1.63 (1.23 to 2.15)), and a 40% higher risk of hypoglycaemia (1.40
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(1.00 to 1.95)). They also found a 35% higher risk of birth injury and a 43% higher risk of being large for gestational age when compared with newborns of women treated with insulin. Infants born to mothers treated with glyburide were not at increased risk for obstetric trauma, preterm birth, or jaundice. The risk of caesarean delivery was 3% lower in the glyburide group. “Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority,” the study concluded.
In an accompanying editorial Richard Holt, of the University of Southampton in the United Kingdom, said, “The main limitation of this and other observational analyses is that the results may be affected by important confounding factors. While the authors have adjusted for important medical conditions, they have not adjusted for all relevant socio-demographic features.” He added, “This latest study heightens residual concerns about the use of glyburide to treat gestational diabetes mellitus that need to be resolved before this drug should be recommended for continued use in pregnancy.”
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Camelo Castillo W, Boggess K, Stürmer T, et al. Association of adverse pregnancy outcomes with glyburide vs insulin in women with gestational diabetes. JAMA Pediatr 2015; published online 30 March; doi:10.1001/jamapediatrics.2015.74. Balsells M, Garcia-Patternson A, Solà I, et al. Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis. BMJ 2015;350:h102.
Cite this as: BMJ 2015;350:h1709 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
Research News
RESEARCH NEWS Use of glyburide to treat gestational diabetes is linked to adverse outcomes in babies, study finds Jacqui Wise London
Babies born to mothers treated with the sulfonylurea drug glyburide (glibenclamide) for gestational diabetes mellitus are more likely to experience adverse outcomes than those whose mothers are treated with insulin, research published in JAMA Pediatrics has found.1 Although the oral hypoglycaemic agent does not have marketing authorisation for use in pregnancy, it is used increasingly widely.
The retrospective cohort study found that glyburide was associated with a higher risk for newborns to be admitted to a neonatal intensive care unit, to have respiratory distress, hypoglycaemia, or birth injury, or to be large for their gestational age when compared with infants born to women treated with insulin.
About a 10th of women with gestational diabetes cannot achieve glucose control through routine care such as dietary measures, physical activity, and glucose monitoring. The standard therapy for women who need drug treatment is insulin, but oral agents are increasingly viewed as potential alternatives because of their easier administration, lower cost, and better acceptance. Several guideline bodies, including the American College of Obstetricians and Gynecologists and the UK National Institute for Health and Care Excellence, have endorsed the use of glyburide. However, other associations, such as the American Diabetes Association, have been more cautious. And a systematic review and meta-analysis published earlier this year in The BMJ concluded that glibenclamide was inferior to insulin and metformin and should not be used to treat women with gestational diabetes.2 This latest US study looked at outcomes in women with gestational diabetes by using data from an employer based insurance claims database from 2000 to 2011. Of 110 879 women with gestational diabetes, 8.3% were treated with glyburide (n=4982) or insulin (n=4193). The proportion of these women treated with glyburide increased from 8.5% in 2000 to 64.4% in 2011. Among infants born to mothers treated with glyburide the researchers found a 41% higher risk of admission to a neonatal intensive care unit (relative risk 1.41 (95% confidence interval 1.23 to 1.62)), a 63% higher risk of respiratory distress (1.63 (1.23 to 2.15)), and a 40% higher risk of hypoglycaemia (1.40
For personal use only: See rights and reprints http://www.bmj.com/permissions
(1.00 to 1.95)). They also found a 35% higher risk of birth injury and a 43% higher risk of being large for gestational age when compared with newborns of women treated with insulin. Infants born to mothers treated with glyburide were not at increased risk for obstetric trauma, preterm birth, or jaundice. The risk of caesarean delivery was 3% lower in the glyburide group. “Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority,” the study concluded.
In an accompanying editorial Richard Holt, of the University of Southampton in the United Kingdom, said, “The main limitation of this and other observational analyses is that the results may be affected by important confounding factors. While the authors have adjusted for important medical conditions, they have not adjusted for all relevant socio-demographic features.” He added, “This latest study heightens residual concerns about the use of glyburide to treat gestational diabetes mellitus that need to be resolved before this drug should be recommended for continued use in pregnancy.”
1 2
Camelo Castillo W, Boggess K, Stürmer T, et al. Association of adverse pregnancy outcomes with glyburide vs insulin in women with gestational diabetes. JAMA Pediatr 2015; published online 30 March; doi:10.1001/jamapediatrics.2015.74. Balsells M, Garcia-Patternson A, Solà I, et al. Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis. BMJ 2015;350:h102.
Cite this as: BMJ 2015;350:h1709 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
