Pharmacokinetics, efficacy and safety of glyburide for treatment of gestational diabetes mellitus

Expert Opinion on Drug Metabolism and Toxicology

Volumn 12, Issue 6, 2016, Pages 691-699

  Malek, Rana ^a   Davis, Stephen N ^b  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF MARYLAND MEDICAL CENTER   (United States)

Author keywords

Efficacy; gestational diabetes mellitus; glyburide; pharmacokinetics; safety

Indexed keywords

GLIBENCLAMIDE; INSULIN; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL;

ACTIVE TRANSPORT; AREA UNDER THE CURVE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN RELEASE; LARGE FOR GESTATIONAL AGE; LIPID SOLUBILITY; LONG TERM CARE; MACROSOMIA; MONOTHERAPY; NEWBORN INTENSIVE CARE; NONHUMAN; ORAL GLUCOSE TOLERANCE TEST; PLACENTAL TRANSFER; PREECLAMPSIA; PREGNANCY DIABETES MELLITUS; REVIEW; SELF MONITORING; STEADY STATE; ANIMAL; DIABETES, GESTATIONAL; DRUG EFFECTS; FEMALE; NEONATAL INTENSIVE CARE UNIT; NEWBORN; PATHOPHYSIOLOGY; PREGNANCY; STATISTICS AND NUMERICAL DATA;

ANIMALS; BLOOD GLUCOSE; DIABETES, GESTATIONAL; FEMALE; GLYBURIDE; HUMANS; HYPOGLYCEMIC AGENTS; INFANT, NEWBORN; INSULIN; INTENSIVE CARE UNITS, NEONATAL; PREGNANCY;

EID: 84969833600     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1080/17425255.2016.1187131     Document Type: Review

References (50)

1. A.Ferrara Increasing prevalence of gestational diabetes mellitus: a public health perspective. Diabetes Care. 2007;30(Suppl 2):S141–146.
2. Freinkel N: Banting Lecture. Of pregnancy and progeny. Diabetes. 1980;29:1023–1035.
3. E.M.Wendland, M.R.Torloni, M.Falavigna, et al. Gestational diabetes and pregnancy outcomes – a systematic review of the World Health Organization (WHO) and the International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria. BMC Pregnancy Childbirth. 2012;12:23.
4. C.M.Boney, A.Verma, R.Tucker, et al. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005;115:e290–296.
5. T.D.Clausen, E.R.Mathiesen, T.Hansen, et al. High prevalence of type 2 diabetes and pre-diabetes in adult offspring of women with gestational diabetes mellitus or type 1 diabetes: the role of intrauterine hyperglycemia. Diabetes Care. 2008;31:340–346.
6. B.E.Metzger. Long-term outcomes in mothers diagnosed with gestational diabetes mellitus and their offspring. Clin Obstet Gynecol. 2007;50:972–979.
7. D.S.Feig, A.Razzaq, K.Sykora, et al. Trends in deliveries, prenatal care, and obstetrical complications in women with pregestational diabetes: a population-based study in Ontario, Canada, 1996–2001. Diabetes Care. 2006;29:232–235.
8. C.Kim, K.M.Newton, R.H.Knopp. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002;25:1862–1868.
9. D.B.Carr, K.M.Utzschneider, R.L.Hull, et al. Gestational diabetes mellitus increases the risk of cardiovascular disease in women with a family history of type 2 diabetes. Diabetes Care. 2006;29:2078–2083.
10. R.Retnakaran, Y.Qi, P.W.Connelly, et al. Glucose intolerance in pregnancy and postpartum risk of metabolic syndrome in young women. J Clin Endocrinol Metab. 2010;95:670–677.
11. O.Langer, D.L.Conway, M.D.Berkus, et al. A comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med. 2000;343:1134–1138.•• This paper was the first trial confirming clinical efficacy of glyburide for treatment of GDM. There were no safety concerns raised with this paper.
12. D.A.Ogunyemi, A.Fong, S.Rad, et al. Attitudes and practices of healthcare providers regarding gestational diabetes: results of a survey conducted at the 2010 meeting of the International Association of Diabetes in Pregnancy Study Group (IADPSG). Diabet Med. 2011;28:976–986.
13. W.Camelo Castillo, K.Boggess, T.Stürmer, et al. Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000–2011. Obstet Gynecol. 2014;123:1177–1184. ••This paper highlighted the widespread off-label use of glyburide for GDM.
14. J.M.Feldman. Glyburide: a second-generation sulfonylurea hypoglycemic agent. History, chemistry, metabolism, pharmacokinetics, clinical use and adverse effects. Pharmacotherapy. 1985;5:43–62.
15. L.A.Jaber, E.J.Antal, R.L.Slaughter, et al. Comparison of pharmacokinetics and pharmacodynamics of short- and long-term glyburide therapy in NIDDM. Diabetes Care. 1994;17:1300–1306.
16. S.Ravindran, O.L.Zharikova, R.A.Hill, et al. Identification of glyburide metabolites formed by hepatic and placental microsomes of humans and baboons. Biochem Pharmacol. 2006;72:1730–1737.
17. T.Rydberg, A.Jönsson, M.Røder, et al. Hypoglycemic activity of glyburide (glibenclamide) metabolites in humans. Diabetes Care. 1994;17:1026–1030.• This paper proved the hypoglycemic properties of glyburide metabolites.
18. B.D.Elliott, O.Langer, S.Schenker, et al. Insignificant transfer of glyburide occurs across the human placenta. Am J Obstet Gynecol. 1991;165:807–812.
19. G.Koren. Glyburide and fetal safety; transplacental pharmacokinetic considerations. Reprod Toxicol. 2001;15:227–229.
20. M.F.Hebert, X.Ma, S.B.Naraharisetti, et al. Are we optimizing gestational diabetes treatment with glyburide? The pharmacologic basis for better clinical practice. Clin Pharmacol Ther. 2009;85:607–614. •This paper highlighted the unique pharmacology of glyburide in pregnant women.
21. R.A.Schwartz, B.Rosenn, K.Aleksa, et al. Glyburide transport across the human placenta. Obstet Gynecol. 2015;125:583–588.
22. D.L.Shuster, L.J.Risler, B.Prasad, et al. Identification of CYP3A7 for glyburide metabolism in human fetal livers. Biochem Pharmacol. 2014;92:690–700.
23. J.Kraemer, J.Klein, A.Lubetsky, et al. Perfusion studies of glyburide transfer across the human placenta: implications for fetal safety. Am J Obstet Gynecol. 2006;195:270–274.
24. V.Ganapathy, P.D.Prasad, M.E.Ganapathy, et al. Placental transporters relevant to drug distribution across the maternal-fetal interface. J Pharmacol Exp Ther. 2000;294:413–420.
25. T.N.Nanovskaya, I.Nekhayeva, G.D.Hankins, et al. Effect of human serum albumin on transplacental transfer of glyburide. Biochem Pharmacol. 2006;72:632–639.
26. M.Maliepaard, G.L.Scheffer, I.F.Faneyte, et al. Subcellular localization and distribution of the breast cancer resistance protein transporter in normal human tissues. Cancer Res. 2001;61:3458–3464.
27. Y.Nakamura, S.Ikeda, T.Furukawa, et al. Function of P-glycoprotein expressed in placenta and mole. Biochem Biophys Res Commun. 1997;235:849–853.
28. M.V.St-Pierre, M.A.Serrano, R.I.Macias, et al. Expression of members of the multidrug resistance protein family in human term placenta. Am J Physiol Regul Integr Comp Physiol. 2000;279:R1495–1503.
29. C.Gedeon, J.Behravan, G.Koren, et al. Transport of glyburide by placental ABC transporters: implications in fetal drug exposure. Placenta. 2006;27:1096–1102.
30. C.Gedeon, G.Anger, M.Piquette-Miller, et al. Breast cancer resistance protein: mediating the trans-placental transfer of glyburide across the human placenta. Placenta. 2008;29:39–43.
31. E.Pollex, A.Lubetsky, G.Koren. The role of placental breast cancer resistance protein in the efflux of glyburide across the human placenta. Placenta. 2008;29:743–747.•This paper defined the role of the BCRP in glyburide efflux across the human placenta.
32. E.K.Pollex, G.Anger, J.Hutson, et al. Breast cancer resistance protein (BCRP)-mediated glyburide transport: effect of the C421A/Q141K BCRP single-nucleotide polymorphism. Drug Metab Dispos. 2010;38:740–744.
33. L.Zhou, S.B.Naraharisetti, L.Liu, et al. Contributions of human cytochrome P450 enzymes to glyburide metabolism. Biopharm Drug Dispos. 2010;31:228–242.
34. L.Zhou, Y.Zhang, M.F.Hebert, et al. Increased glyburide clearance in the pregnant mouse model. Drug Metab Dispos. 2010;38:1403–1406.
35. G.J.Anger. Piquette-Miller M: Impact of hyperlipidemia on plasma protein binding and hepatic drug transporter and metabolic enzyme regulation in a rat model of gestational diabetes. J Pharmacol Exp Ther. 2010;334:21–32.•This paper showed that plasma lipids impact the degree of glyburide transfer across the placenta.
36. N.Myngheer, K.Allegaert, A.Hattersley, et al. Fetal macrosomia and neonatal hyperinsulinemic hypoglycemia associated with transplacental transfer of sulfonylurea in a mother with KCNJ11-related neonatal diabetes. Diabetes Care. 2014;37:3333–3335.
37. G.F.Jacobson, G.A.Ramos, J.Y.Ching, et al. Comparison of glyburide and insulin for the management of gestational diabetes in a large managed care organization. Am J Obstet Gynecol. 2005;193:118–124. •This large study noted increased rates of preeclampsia and longer NICU admissions in mothers on glyburide for GDM.
38. M.Mirzamoradi, Z.Heidar, Z.Faalpoor, et al. Comparison of glyburide and insulin in women with gestational diabetes mellitus and associated perinatal outcome: a randomized clinical trial. Acta Med Iran. 2015;53:97–103.
39. C.Anjalakshi, V.Balaji, M.S.Balaji, et al. A prospective study comparing insulin and glibenclamide in gestational diabetes mellitus in Asian Indian women. Diabetes Res Clin Pract. 2007;76:474–475.
40. Y.-F.Jiang, X.-Y.Chen, T.Ding, et al. Comparative efficacy and safety of OADs in management of GDM: network meta-analysis of randomized controlled trials. J Clin Endocrinol Metab. 2015;100:2071–2080.
41. D.L.Conway, O.Gonzales, Skiver D: Use of glyburide for the treatment of gestational diabetes: the San Antonio experience. J Matern Fetal Neonatal Med. 2004;15:51–55.
42. R.Chmait, T.Dinise, T.Moore. Prospective observational study to establish predictors of glyburide success in women with gestational diabetes mellitus. J Perinatol. 2004;24:617–622.
43. M.E.Moretti, M.Rezvani. Koren G: Safety of glyburide for gestational diabetes: a meta-analysis of pregnancy outcomes. Ann Pharmacother. 2008;42:483–490.
44. G.A.Ramos, G.F.Jacobson, R.S.Kirby, et al. Comparison of glyburide and insulin for the management of gestational diabetics with markedly elevated oral glucose challenge test and fasting hyperglycemia. J Perinatol. 2007;27:262–267.• This study noted higher rates of macrosomia and neonatal hypoglycemia with glyburide use.
45. Y.W.Cheng, J.H.Chung, I.Block-Kurbisch, et al. Treatment of gestational diabetes mellitus: glyburide compared to subcutaneous insulin therapy and associated perinatal outcomes. J Matern Fetal Neonatal Med. 2012;25:379–384.
46. W.Camelo Castillo, K.Boggess, T.Stürmer, et al. Association of adverse pregnancy outcomes with glyburide vs insulin in women with gestational diabetes. JAMA Pediatr. 2015;169:452–458.
47. Y.Yogev, A.Ben-Haroush, R.Chen, et al. Undiagnosed asymptomatic hypoglycemia: diet, insulin, and glyburide for gestational diabetic pregnancy. Obstet Gynecol. 2004;104:88–93.
48. T.L.Hernandez, J.E.Friedman, R.E.Van Pelt, et al. Patterns of glycemia in normal pregnancy: should the current therapeutic targets be challenged?. Diabetes Care. 2011;34:1660–1668.
49. S.Stark Casagrande, J.E.Fradkin, S.H.Saydah, et al. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013;36:2271–2279.
50. A.S.Gangji, T.Cukierman, H.C.Gerstein, et al. A systematic review and meta-analysis of hypoglycemia and cardiovascular events: a comparison of glyburide with other secretagogues and with insulin. Diabetes Care. 2007;30:389–394.