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Newborns of women who have gestational diabetes treated with glyburide appear to be at increased risk for admission to the neonatal intensive care unit, respiratory distress, hypoglycemia, birth injury, and large for gestational age status, compared with newborns of women treated with insulin, according to a report published March 30 in JAMA Pediatrics.
In recent years, off-label use of glyburide for gestational diabetes has risen dramatically in the United States. A few small clinical trials and observational studies have suggested that the agent is associated with poorer neonatal outcomes than insulin. Currently, insulin is the only pharmacologic treatment approved for the treatment of gestational diabetes mellitus by the Food and Drug Administration and endorsed by the American Diabetes Association.
To examine the issue in a study population large enough to detect small, but clinically important, differences between the two treatments, researchers performed a retrospective cohort study involving 9,173 mother/infant pairs enrolled in a health plan database that covered approximately 30 million patients per year across the United States.
Compared with insulin, glyburide was associated with an increased risk in the newborns of NICU admission (adjusted relative risk, 1.41), respiratory distress (aRR, 1.63), neonatal hypoglycemia (aRR, 1.40), birth injury (aRR, 1.35), and large for gestation age status (aRR, 1.43).
Glyburide was not associated with an increased risk of neonatal jaundice, obstetric trauma, or preterm birth, the investigators wrote (JAMA Pediatr. 2015 March 30 [doi:10.1001/jamapediatrics.2015.74]).
The study population included women (average age, 33.5 years) who delivered singleton live-born infants in 2000-2011 and who filed pharmacy claims for either glyburide (4,982 patients) or insulin (4,191 patients) during the 150 days preceding delivery.
The mean duration of treatment was 50.4 days with glyburide and 54.1 days with insulin.
The proportion of women treated with glyburide rose from 8.5% at the beginning of the study period to 64.4% at the end, wrote Wendy Camelo Castillo, Ph.D., of the department of pharmaceutical health services research, University of Maryland, Baltimore, and her associates.
Glyburide’s link to adverse outcomes “demands further attention” and suggests that women treated with the drug are not achieving adequate glucose control, the researchers wrote.
The Agency for Healthcare Research and Quality and the University of North Carolina at Chapel Hill supported the study. Dr. Camelo Castillo reported having no financial disclosures; her associates reported financial ties to varous pharmaceutical companies.
These findings, together with those of previous studies, are cause for concern and indicate that the time has come to reconsider the place of glyburide in pregnancy.
Infants of women treated with glyburide had a 41% higher risk for NICU admission, a 63% higher risk of respiratory distress, a 40% higher risk of hypoglycemia, and a 35% higher risk of birth injury, compared with infants born to women treated with insulin. The large study sample provides much more statistical power than prior randomized clinical trials to detect any differences in outcomes and to characterize those differences with greater precision.
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Dr. Richard I.G. Holt |
Richard I.G. Holt, Ph.D., is in the human development and health academic unit at the University of Southampton (U.K.). He was a member of the 2008 National Institute for Health and Care Excellence diabetes and pregnancy guideline development group. He reported having no financial disclosures. These comments are based on Dr. Holt’s accompanying editorial (JAMA Pediatr. 2015 March 30 [doi:10.1001/jamapediatrics.2015.144]).
These findings, together with those of previous studies, are cause for concern and indicate that the time has come to reconsider the place of glyburide in pregnancy.
Infants of women treated with glyburide had a 41% higher risk for NICU admission, a 63% higher risk of respiratory distress, a 40% higher risk of hypoglycemia, and a 35% higher risk of birth injury, compared with infants born to women treated with insulin. The large study sample provides much more statistical power than prior randomized clinical trials to detect any differences in outcomes and to characterize those differences with greater precision.
|
Dr. Richard I.G. Holt |
Richard I.G. Holt, Ph.D., is in the human development and health academic unit at the University of Southampton (U.K.). He was a member of the 2008 National Institute for Health and Care Excellence diabetes and pregnancy guideline development group. He reported having no financial disclosures. These comments are based on Dr. Holt’s accompanying editorial (JAMA Pediatr. 2015 March 30 [doi:10.1001/jamapediatrics.2015.144]).
These findings, together with those of previous studies, are cause for concern and indicate that the time has come to reconsider the place of glyburide in pregnancy.
Infants of women treated with glyburide had a 41% higher risk for NICU admission, a 63% higher risk of respiratory distress, a 40% higher risk of hypoglycemia, and a 35% higher risk of birth injury, compared with infants born to women treated with insulin. The large study sample provides much more statistical power than prior randomized clinical trials to detect any differences in outcomes and to characterize those differences with greater precision.
|
Dr. Richard I.G. Holt |
Richard I.G. Holt, Ph.D., is in the human development and health academic unit at the University of Southampton (U.K.). He was a member of the 2008 National Institute for Health and Care Excellence diabetes and pregnancy guideline development group. He reported having no financial disclosures. These comments are based on Dr. Holt’s accompanying editorial (JAMA Pediatr. 2015 March 30 [doi:10.1001/jamapediatrics.2015.144]).
Newborns of women who have gestational diabetes treated with glyburide appear to be at increased risk for admission to the neonatal intensive care unit, respiratory distress, hypoglycemia, birth injury, and large for gestational age status, compared with newborns of women treated with insulin, according to a report published March 30 in JAMA Pediatrics.
In recent years, off-label use of glyburide for gestational diabetes has risen dramatically in the United States. A few small clinical trials and observational studies have suggested that the agent is associated with poorer neonatal outcomes than insulin. Currently, insulin is the only pharmacologic treatment approved for the treatment of gestational diabetes mellitus by the Food and Drug Administration and endorsed by the American Diabetes Association.
To examine the issue in a study population large enough to detect small, but clinically important, differences between the two treatments, researchers performed a retrospective cohort study involving 9,173 mother/infant pairs enrolled in a health plan database that covered approximately 30 million patients per year across the United States.
Compared with insulin, glyburide was associated with an increased risk in the newborns of NICU admission (adjusted relative risk, 1.41), respiratory distress (aRR, 1.63), neonatal hypoglycemia (aRR, 1.40), birth injury (aRR, 1.35), and large for gestation age status (aRR, 1.43).
Glyburide was not associated with an increased risk of neonatal jaundice, obstetric trauma, or preterm birth, the investigators wrote (JAMA Pediatr. 2015 March 30 [doi:10.1001/jamapediatrics.2015.74]).
The study population included women (average age, 33.5 years) who delivered singleton live-born infants in 2000-2011 and who filed pharmacy claims for either glyburide (4,982 patients) or insulin (4,191 patients) during the 150 days preceding delivery.
The mean duration of treatment was 50.4 days with glyburide and 54.1 days with insulin.
The proportion of women treated with glyburide rose from 8.5% at the beginning of the study period to 64.4% at the end, wrote Wendy Camelo Castillo, Ph.D., of the department of pharmaceutical health services research, University of Maryland, Baltimore, and her associates.
Glyburide’s link to adverse outcomes “demands further attention” and suggests that women treated with the drug are not achieving adequate glucose control, the researchers wrote.
The Agency for Healthcare Research and Quality and the University of North Carolina at Chapel Hill supported the study. Dr. Camelo Castillo reported having no financial disclosures; her associates reported financial ties to varous pharmaceutical companies.
Newborns of women who have gestational diabetes treated with glyburide appear to be at increased risk for admission to the neonatal intensive care unit, respiratory distress, hypoglycemia, birth injury, and large for gestational age status, compared with newborns of women treated with insulin, according to a report published March 30 in JAMA Pediatrics.
In recent years, off-label use of glyburide for gestational diabetes has risen dramatically in the United States. A few small clinical trials and observational studies have suggested that the agent is associated with poorer neonatal outcomes than insulin. Currently, insulin is the only pharmacologic treatment approved for the treatment of gestational diabetes mellitus by the Food and Drug Administration and endorsed by the American Diabetes Association.
To examine the issue in a study population large enough to detect small, but clinically important, differences between the two treatments, researchers performed a retrospective cohort study involving 9,173 mother/infant pairs enrolled in a health plan database that covered approximately 30 million patients per year across the United States.
Compared with insulin, glyburide was associated with an increased risk in the newborns of NICU admission (adjusted relative risk, 1.41), respiratory distress (aRR, 1.63), neonatal hypoglycemia (aRR, 1.40), birth injury (aRR, 1.35), and large for gestation age status (aRR, 1.43).
Glyburide was not associated with an increased risk of neonatal jaundice, obstetric trauma, or preterm birth, the investigators wrote (JAMA Pediatr. 2015 March 30 [doi:10.1001/jamapediatrics.2015.74]).
The study population included women (average age, 33.5 years) who delivered singleton live-born infants in 2000-2011 and who filed pharmacy claims for either glyburide (4,982 patients) or insulin (4,191 patients) during the 150 days preceding delivery.
The mean duration of treatment was 50.4 days with glyburide and 54.1 days with insulin.
The proportion of women treated with glyburide rose from 8.5% at the beginning of the study period to 64.4% at the end, wrote Wendy Camelo Castillo, Ph.D., of the department of pharmaceutical health services research, University of Maryland, Baltimore, and her associates.
Glyburide’s link to adverse outcomes “demands further attention” and suggests that women treated with the drug are not achieving adequate glucose control, the researchers wrote.
The Agency for Healthcare Research and Quality and the University of North Carolina at Chapel Hill supported the study. Dr. Camelo Castillo reported having no financial disclosures; her associates reported financial ties to varous pharmaceutical companies.
Key clinical point: The newborns of women with gestational diabetes treated with glyburide are at increased risk for adverse outcomes, compared with newborns of women treated with insulin.
Major finding: Compared with insulin, glyburide was associated with an increased risk in newborns of NICU admission (adjusted relative risk, 1.41), respiratory distress (aRR, 1.63), neonatal hypoglycemia (aRR, 1.40), birth injury (aRR, 1.35), and LGA status (aRR, 1.43).
Data source: A retrospective cohort study of pregnancy and neonatal outcomes in 9,173 mothers across the United States who received pharmacotherapy for gestational diabetes during a 12-year period.
Disclosures: The Agency for Healthcare Research and Quality and the University of North Carolina at Chapel Hill supported the study. Dr. Camelo Castillo reported having no financial disclosures; her associates reported financial ties to various pharmaceutical companies.
