title: Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes.
abstract: OBJECTIVE
  Glyburide is thought to be safe for use during pregnancy for treatment of gestational diabetes mellitus (GDM). However, there are limited data on the effectiveness of glyburide when compared with insulin as used in a real-world setting.
  
  
  OBJECTIVE
  To estimate the risk of adverse maternal and neonatal outcomes in women with GDM treated with glyburide compared with insulin.
  
  
  METHODS
  Retrospective cohort study of a population-based cohort from a nationwide US employer-based insurance claims database from January 1, 2000, to December 31, 2011. We identified women with GDM and their newborns. We excluded those with type 1 or 2 diabetes and those younger than 15 years or older than 45 years.
  
  
  METHODS
  Treatment with glyburide or insulin during pregnancy within 150 days before delivery.
  
  
  METHODS
  We used binomial regression to estimate risk ratios (RRs) and risk differences with 95% confidence intervals for the association of glyburide with diagnosis codes for obstetric trauma, cesarean delivery, birth injury, preterm birth, hypoglycemia, respiratory distress, jaundice, large for gestational age, and hospitalization in the neonatal intensive care unit. Inverse probability of treatment weights were used to adjust for maternal characteristics that differed between the treatment groups.
  
  
  RESULTS
  Among 110,879 women with GDM, 9173 women (8.3%) were treated with glyburide (n = 4982) or insulin (n = 4191). After adjusting for differences at baseline, newborns of women treated with glyburide were at increased risk for neonatal intensive care unit admission (RR = 1.41; 95% CI, 1.23-1.62), respiratory distress (RR = 1.63; 95% CI, 1.23-2.15), hypoglycemia (RR = 1.40; 95% CI, 1.00-1.95), birth injury (RR = 1.35; 95% CI, 1.00-1.82), and large for gestational age (RR = 1.43; 95% CI, 1.16-1.76) compared with those treated with insulin; they were not at increased risk for obstetric trauma (RR = 0.92; 95% CI, 0.71-1.20), preterm birth (RR = 1.06; 95% CI, 0.93-1.21), or jaundice (RR = 0.96; 95% CI, 0.48-1.91). The risk of cesarean delivery was 3% lower in the glyburide group (adjusted RR = 0.97; 95% CI, 0.93-1.00). The risk difference associated with glyburide was 2.97% (95% CI, 1.82-4.12) for neonatal intensive care unit admission, 1.41% (95% CI, 0.61-2.20) for large for gestational age, and 1.11% (95% CI, 0.50-1.72) for respiratory distress.
  
  
  CONCLUSIONS
  Newborns from privately insured mothers treated with glyburide were more likely to experience adverse outcomes than those from mothers treated with insulin. Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority.
authors.affiliation: Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore2Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.
authors.forename: Wendy
authors.initials: W
authors.lastname: Camelo Castillo
authors.affiliation: Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill.
authors.forename: Kim
authors.initials: K
authors.lastname: Boggess
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.
authors.forename: Til
authors.initials: T
authors.lastname: Stürmer
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.
authors.forename: M Alan
authors.initials: MA
authors.lastname: Brookhart
authors.affiliation: Department of Pediatrics, Duke University, Durham, North Carolina.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Benjamin
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.
authors.forename: Michele
authors.initials: M
authors.lastname: Jonsson Funk
mesh_terms: D000328:Adult; D015331:Cohort Studies; D016640:Diabetes, Gestational / Q000188:drug therapy*; D005260:Female; D005905:Glyburide / Q000009:adverse effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000139:chemically induced; D007328:Insulin / Q000009:adverse effects*; D007744:Obstetric Labor Complications / Q000139:chemically induced; D011247:Pregnancy; D011256:Pregnancy Outcome; D012044:Regression Analysis; D012189:Retrospective Studies
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D005905:Glyburide