Background Women with gestational diabetes mellitus are rarelytreated with a sulfonylurea drug, because of concern about teratogenicityand neonatal hypoglycemia. There is little information aboutthe efficacy of these drugs in this group of women.
Methods We studied 404 women with singleton pregnancies andgestational diabetes that required treatment. The women wererandomly assigned between 11 and 33 weeks of gestation to receiveglyburide or insulin according to an intensified treatment protocol.The primary end point was achievement of the desired level ofglycemic control. Secondary end points included maternal andneonatal complications.
Results The mean (±SD) pretreatment blood glucose concentrationas measured at home for one week was 114±19 mg per deciliter(6.4±1.1 mmol per liter) in the glyburide group and 116±22mg per deciliter (6.5±1.2 mmol per liter) in the insulingroup (P=0.33). The mean concentrations during treatment were105± 16 mg per deciliter (5.9±0.9 mmol per liter)in the glyburide group and 105±18 mg per deciliter (5.9±1.0mmol per liter) in the insulin group (P=0.99). Eight women inthe glyburide group (4 percent) required insulin therapy. Therewere no significant differences between the glyburide and insulingroups in the percentage of infants who were large for gestationalage (12 percent and 13 percent, respectively); who had macrosomia,defined as a birth weight of 4000 g or more (7 percent and 4percent); who had lung complications (8 percent and 6 percent);who had hypoglycemia (9 percent and 6 percent); who were admittedto a neonatal intensive care unit (6 percent and 7 percent);or who had fetal anomalies (2 percent and 2 percent). The cord-seruminsulin concentrations were similar in the two groups, and glyburidewas not detected in the cord serum of any infant in the glyburidegroup.
Conclusions In women with gestational diabetes, glyburide isa clinically effective alternative to insulin therapy.
Source Information
From the Department of Obstetrics and Gynecology, St. Luke'sRoosevelt Hospital Center, New York (O.L.); and the Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, San Antonio (D.L.C., M.D.B., E.M.-J.X., O.G.).
Address reprint requests to Dr. Langer at the Department of Obstetrics and Gynecology, St. Luke'sRoosevelt Hospital Center, 1000 10th Ave., New York, NY 10019, or at olanger{at}slrhc.org.
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