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• W4249898462 abstract "We thank Drs Ross and Kjos for their interest in our study. We agree that data regarding placental transport of glyburide are important for safety and efficacy information regarding the use of glyburide during pregnancy. Our study was an equivalency trial between glyburide and insulin, evaluating neonatal adiposity measured by total body electric conductance (TOBEC).1Lain K.Y. Garabedian M.J. Daftary A. Jeyabalan A. Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin.Am J Obstet Gynecol. 2009; 200: 501.e1-501.e6Abstract Full Text Full Text PDF Scopus (53) Google Scholar We demonstrated no difference in the primary outcome: neonatal percent fat mass. TOBEC was utilized, because percent fat mass better identifies subtle differences in body composition compared with birthweight or birthweight percentiles.2Lain K.Y. Catalano P.M. Factors that affect maternal insulin resistance and modify fetal growth and body composition.Metab Syndr Relat Disord. 2006; 4: 91-100Crossref PubMed Scopus (19) Google Scholar In our study, there was a difference in the distribution of percentile by weight (<10%, for appropriate for gestational age, and >90%; P = .01) and macrosomia (P = .01), but these measures are less precise measures of adiposity. Percentiles are flawed, because they are population and time specific and do not describe growth rate or growth potential. Furthermore, not all neonates at the extremes of size are pathologically small or large. In addition, any individual skinfold or circumference measure is limited compared with composite measures such as skinfold sum or arm fat area. Finally, fat mass and fat-free mass are correlated with birthweight and will increase with overall increasing weight. Importantly, however, the percent fat mass of each neonate, our primary outcome, was not different between groups. Individual and composite measures were included, but we did not have the power to observe differences in all secondary outcomes.1Lain K.Y. Garabedian M.J. Daftary A. Jeyabalan A. Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin.Am J Obstet Gynecol. 2009; 200: 501.e1-501.e6Abstract Full Text Full Text PDF Scopus (53) Google Scholar Concern was also raised for glyburide-induced fetal insulinemia and potential adverse effects on fetal programming. We included maternal and neonatal (cord blood) metabolic markers.1Lain K.Y. Garabedian M.J. Daftary A. Jeyabalan A. Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin.Am J Obstet Gynecol. 2009; 200: 501.e1-501.e6Abstract Full Text Full Text PDF Scopus (53) Google Scholar Although not powered for these secondary outcomes, there were no differences in cord blood insulin, c-peptide, or adiponectin concentrations. Approximately 570 neonates per group are needed to demonstrate differences in c-peptide. Only maternal glucose was lower in the glyburide group at time of delivery, with a trend of lower glucose in cord blood. There was also no difference in the insulin to glucose ratio. In summary, these biomarker data did not provide evidence of differences in fetal insulin production, exposure, or resistance. We agree that more data overall are needed regarding fetal exposure to different methods of glucose control for patients with diabetes during pregnancy. We hope that our data from this small, randomized clinical trial contribute to the questions regarding the use of glyburide for maternal glucose control. Glyburide: caution for efficacy and fetal programming effectsAmerican Journal of Obstetrics & GynecologyVol. 202Issue 4PreviewWe read with interest the article of Lain et al,1 “Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin.” The authors concluded that glyburide and insulin are equally effective for treatment of gestational diabetes mellitus, with no difference in neonatal adiposity, suggesting that this adds “to the safety data for the use of glyburide during pregnancy.” However, an assessment of their results and an understanding of new data regarding glyburide and fetal programming suggest that these conclusions should be reassessed. Full-Text PDF" @default.
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