Can pregnant diabetics be treated with glyburide?

Women's Health

Volumn 5, Issue 6, 2009, Pages 649-658

  Melamed, Nir ^a,b   Yogev, Yariv ^a,b  

^a RABIN MEDICAL CENTER   (Israel)

^b TEL AVIV UNIVERSITY   (Israel)

Author keywords

Drugs; Gestational diabetes; Glibenclamide; Glyburide; Oral hypoglycemic

Indexed keywords

ACETOHEXAMIDE; CHLORPROPAMIDE; GLIBENCLAMIDE; GLIMEPIRIDE; GLIPIZIDE; INSULIN; ORAL ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE; TOLBUTAMIDE;

CLINICAL TRIAL; CONGENITAL MALFORMATION; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; ETHNICITY; FETOMATERNAL TRANSFUSION; FETUS MALFORMATION; FIRST TRIMESTER PREGNANCY; GLYCEMIC CONTROL; GROWTH DISORDER; HUMAN; HYPOGLYCEMIA; LARGE FOR GESTATIONAL AGE; MACROSOMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; ORAL GLUCOSE TOLERANCE TEST; PLACENTAL TRANSFER; PREGNANCY DIABETES MELLITUS; PREVALENCE; REVIEW; RISK FACTOR; SMALL FOR DATE INFANT; TERATOGENICITY; UMBILICAL CORD BLOOD;

DIABETES, GESTATIONAL; DRUG THERAPY, COMBINATION; FEMALE; GLYBURIDE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MATERNAL-FETAL EXCHANGE; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS;

EID: 70549098562     PISSN: 17455057     EISSN: 17455065     Source Type: Journal    
DOI: 10.2217/whe.09.55     Document Type: Review

References (56)

1. Moore T: Diabetes in pregnancy. In: Maternal-Fetal Medicine: Principles and Practice. Creasy RK, Resnik R, Iams JD (Eds). Saunders, Philadelphia, PA, USA 1023-1061 (2004).
2. Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS: Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N. Engl. J. Med. 352, 2477-2486 (2005).
3. Langer O, Yogev Y, Most O, Xenakis EM: Gestational diabetes: the consequences of not treating. Am. J. Obstet. Gynecol. 192, 989-997 (2005).
4. Landon MB, Thom E, Spong CY et al.: The National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network randomized clinical trial in progress: standard therapy versus no therapy for mild gestational diabetes. Diabetes Care 30 (Suppl. 2), S194-S199 (2007).
5. Diabetes and pregnancy. ACOG technical bulletin no.200 (replaces no. 92). American College of Obstetricians and Gynecologists, Washington, DC, USA. 359-366 (1994).
6. American Diabetes Association: Gestational diabetes mellitus. Diabetes Care 21(Suppl. 1), S60-S61 (1998).
7. Metzger BE, Coustan DR: Summary and recommendations of the Fourth International Workshop-Conference on gestational diabetes mellitus. The Organizing Committee. Diabetes Care 21(Suppl. 2), B161-B167 (1998).
8. Zucker P, Simon G: Prolonged symptomatic neonatal hypoglycemia associated with maternal chlorpropamide therapy. Pediatrics 42, 824-825 (1968).
9. Farquhar JW, Isles TE: Hypoglycemia in newborn infants of normal and diabetic mothers. S. Afr. Med. J. 42, 237-245 (1968).
10. Kemball ML, McIver C, Milner RD, Nourse CH, Schiff D, Tiernan JR: Neonatal hypoglycaemia in infants of diabetic mothers given sulphonylurea drugs in pregnancy. Arch. Dis. Child 45, 696-701 (1970).
11. Denno KM, Sadler TW: Effects of the biguanide class of oral hypoglycemic agents on mouse embryogenesis. Teratology 49, 260-266 (1994).
12. Smoak IW, Sadler TW: Embryopathic effects of short-term exposure to hypoglycemia in mouse embryos in vitro. Am. J. Obstet. Gynecol. 163, 619-624 (1990).
13. Piacquadio K, Hollingsworth DR, Murphy H: Effects of in utero exposure to oral hypoglycaemic drugs. Lancet 338, 866-869 (1991).
14. Sutherland HW, Stowers JM, Cormack JD, Bewsher PD: Evaluation of chlorpropamide in chemical diabetes diagnosed during pregnancy. Br. Med. J. 3, 9-13 (1973).
15. Sutherland HW, Bewsher PD, Cormack JD et al.: Effect of moderate dosage of chlorpropamide in pregnancy on fetal outcome. Arch. Dis. Child 49, 283-291 (1974).
16. Notelovitz M: Letter: Oral hypoglycaemic therapy in diabetic pregnancies. Lancet 2, 902-903 (1974).
17. Coetzee EJ, Jackson WP: Oral hypoglycaemics in the first trimester and fetal outcome. S. Afr. Med. J. 65, 635-637 (1984).
18. Langer O, Conway DL, Berkus MD, Xenakis EM, Gonzales O: A comparison of glyburide and insulin in women with gestational diabetes mellitus. N. Engl. J. Med. 343, 1134-1138 (2000). (Pubitemid 30781983) •• Landmark randomized controlled study comparing insulin and glyburide in the management of gestational diabetes.
19. Kaaja R, Ronnemaa T: Gestational diabetes: pathogenesis and consequences to mother and offspring. Rev. Diabet. Stud. 5, 194-202 (2008).
20. Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care 23(Suppl. 1), S27-S31 (2000).
21. Gabbe SG, Gregory RP, Power ML, Williams SB, Schulkin J: Management of diabetes mellitus by obstetrician- gynecologists. Obstet. Gynecol. 103, 1229-1234 (2004).
22. Smoak IW: Embryopathic effects of the oral hypoglycemic agent chlorpropamide in cultured mouse embryos. Am. J. Obstet. Gynecol. 169, 409-414 (1993).
23. Towner D, Kjos SL, Leung B et al.: Congenital malformations in pregnancies complicated by NIDDM. Diabetes Care 18, 1446-1451 (1995).
24. Schaefer-Graf UM, Buchanan TA, Xiang A, Songster G, Montoro M, Kjos SL: Patterns of congenital anomalies and relationship to initial maternal fasting glucose levels in pregnancies complicated by type 2 and gestational diabetes. Am. J. Obstet. Gynecol. 182, 313-320 (2000).
25. Sheffield JS, Butler-Koster EL, Casey BM, McIntire DD, Leveno KJ: Maternal diabetes mellitus and infant malformations. Obstet. Gynecol. 100, 925-930 (2002).
26. Elliott BD, Langer O, Schenker S, Johnson RF: Insignificant transfer of glyburide occurs across the human placenta. Am. J. Obstet. Gynecol. 165, 807-812 (1991). • First study to report that glyburide crosses the placenta only in minimal amounts.
27. Elliott BD, Schenker S, Langer O, Johnson R, Prihoda T: Comparative placental transport of oral hypoglycemic agents in humans: a model of human placental drug transfer. Am. J. Obstet. Gynecol. 171, 653-660 (1994).
28. Koren G: Glyburide and fetal safety: transplacental pharmacokinetic considerations. Reprod. Toxicol. 15, 227-229 (2001).
29. Gedeon C, Behravan J, Koren G, Piquette- Miller M: Transport of glyburide by placental ABC transporters: implications in fetal drug exposure. Placenta 27, 1096-1102 (2006).
30. Kraemer J, Klein J, Lubetsky A, Koren G: Perfusion studies of glyburide transfer across the human placenta: implications for fetal safety. Am. J. Obstet. Gynecol. 195, 270-274 (2006).
31. Kremer CJ, Duff P: Glyburide for the treatment of gestational diabetes. Am. J. Obstet. Gynecol. 190, 1438-1439 (2004).
32. Jacobson GF, Ramos GA, Ching JY, Kirby RS, Ferrara A, Field DR: Comparison of glyburide and insulin for the management of gestational diabetes in a large managed care organization. Am. J. Obstet. Gynecol. 193, 118-124 (2005).
33. Ramos GA, Jacobson GF, Kirby RS, Ching JY, Field DR: Comparison of glyburide and insulin for the management of gestational diabetics with markedly elevated oral glucose challenge test and fasting hyperglycemia. J. Perinatol. 27, 262-267 (2007).
34. Lain KY, Garabedian MJ, Daftary A, Jeyabalan A: Neonatal adiposity following maternal treatment of gestational diabetes with glyburide compared with insulin. Am. J. Obstet. Gynecol. 200, 501 E1-E6 (2009).
35. Klieger C, Pollex E, Koren G: Treating the mother - protecting the unborn: the safety of hypoglycemic drugs in pregnancy. J. Matern. Fetal Neonatal Med. 21, 191-196 (2008).
36. Gutzin SJ, Kozer E, Magee LA, Feig DS, Koren G: The safety of oral hypoglycemic agents in the first trimester of pregnancy: a meta-analysis. Can. J. Clin. Pharmacol. 10, 179-183 (2003). • One of the important sources regarding the safety of glyburide in early pregnancy.
37. Sivan E, Feldman B, Dolitzki M, Nevo N, Dekel N, Karasik A: Glyburide crosses the placenta in vivo in pregnant rats. Diabetologia 38, 753-756 (1995).
38. Hebert M, Ma X, Naraharisetti S et al.: Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin. Pharmacol. Ther. 85, 607-614 (2009). • First study investigating the pharmacokinetics of glyburide in pregnant women.
39. American Diabetes Association: Gestational diabetes mellitus. Diabetes Care 27 (Suppl. 1), S88-S90 (2004).
40. ACOG Practice Bulletin. Clinical management guidelines for obstetrician- gynecologists. No.30, September 2001 (replaces Technical Bulletin No. 200, December 1994). Gestational diabetes. Obstet. Gynecol. 98, 525-538 (2001).
41. Kitzmiller J: Limited efficacy of glyburide for glycemic control. Am. J. Obstet. Gynecol. 185(Suppl. 6), S198 (1991).
42. Bertini AM, Silva JC, Taborda W et al.: Perinatal outcomes and the use of oral hypoglycemic agents. J. Perinat. Med. 33, 519-523 (2005).
43. Nicholson W, Bolen S, Witkop CT, Neale D, Wilson L, Bass E: Benefits and risks of oral diabetes agents compared with insulin in women with gestational diabetes: a systematic review. Obstet. Gynecol. 113, 193-205 (2009).
44. Moretti ME, Rezvani M, Koren G: Safety of glyburide for gestational diabetes: a meta-analysis of pregnancy outcomes. Ann. Pharmacother. 42, 483-490 (2008).
45. Langer O, Yogev Y, Xenakis EM, Rosenn B: Insulin and glyburide therapy: dosage, severity level of gestational diabetes, and pregnancy outcome. Am. J. Obstet. Gynecol. 192, 134-139 (2005).
46. Moore TR: Glyburide for the treatment of gestational diabetes. A critical appraisal. Diabetes Care 30(Suppl. 2), S209-S213 (2007). •• Recent critical review that discusses the limitations of the randomized study of Langer et al. and the subsequent case-control and cohort studies.
47. Chmait R, Dinise T, Moore T: Prospective observational study to establish predictors of glyburide success in women with gestational diabetes mellitus. J. Perinatol. 24, 617-622 (2004).
48. Rochon M, Rand L, Roth L, Gaddipati S: Glyburide for the management of gestational diabetes: risk factors predictive of failure and associated pregnancy outcomes. Am. J. Obstet. Gynecol. 195, 1090-1094 (2006).
49. Conway DL, Gonzales O, Skiver D: Use of glyburide for the treatment of gestational diabetes: the San Antonio experience. J. Matern. Fetal Neonatal Med. 15, 51-55 (2004).
50. Kahn BF, Davies JK, Lynch AM, Reynolds RM, Barbour LA: Predictors of glyburide failure in the treatment of gestational diabetes. Obstet. Gynecol. 107, 1303-1309 (2006).
51. Goetzl L, Wilkins I: Glyburide compared to insulin for the treatment of gestational diabetes mellitus: a cost analysis. J. Perinatol. 22, 403-406 (2002).
52. Greene MF: Oral hypoglycemic drugs for gestational diabetes. N. Engl. J. Med. 343, 1178-1179 (2000).
53. Gabbe SG, Graves CR: Management of diabetes mellitus complicating pregnancy. Obstet. Gynecol. 102, 857-868 (2003).
54. Koren G: The use of glyburide in gestational diabetes - an ideal example of 'bench to bedside'. Pediatr. Res. 49, 734 (2001).
55. Kitzmiller JL, Block JM, Brown FM et al.: Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes Care 31, 1060-1079 (2008).
56. Kitzmiller J: Limited efficacy of glyburide for glycemic control. Am. J. Obstet. Gynecol. 185(Suppl. 6), S198 (2001).