Hypoglycemics: Pharmacokinetic considerations during pregnancy

Therapeutic Drug Monitoring

Volumn 31, Issue 5, 2009, Pages 533-541

  Klieger, Chagit ^a   Pollex, Erika ^a   Kazmin, Aleksey ^a   Koren, Gideon ^a  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

Author keywords

Diabetes; Hypoglycemic agents; Pharmacokinetics; Pregnancy

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ACARBOSE; EXENDIN 4; GLIBENCLAMIDE; GLICLAZIDE; HUMAN INSULIN; INSULIN; INSULIN ASPART; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; METFORMIN; MIGLITOL; NICARDIPINE; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; RECOMBINANT HUMAN INSULIN; REPAGLINIDE; ROSIGLITAZONE; SULFONAMIDE; SULFONYLUREA DERIVATIVE; WARFARIN;

CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DIABETIC NEPHROPATHY; DIABETIC RETINOPATHY; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; EVENING DOSAGE; FETOMATERNAL TRANSFUSION; GLUCOSE METABOLISM; HORMONAL REGULATION; HUMAN; HYPERINSULINEMIA; HYPOGLYCEMIA; INSULIN BLOOD LEVEL; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN RELEASE; INSULIN RESISTANCE; INSULIN SENSITIVITY; LUNG FUNCTION; MACROSOMIA; MATERNAL SERUM; NON INSULIN DEPENDENT DIABETES MELLITUS; OVARY POLYCYSTIC DISEASE; PATIENT COMPLIANCE; PLACENTAL TRANSFER; PREGNANCY; PREGNANCY DIABETES MELLITUS; PRIORITY JOURNAL; PROTEIN BINDING; REVIEW; SIDE EFFECT; STOMACH EMPTYING; UMBILICAL CORD BLOOD;

DEPRESSION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MATERNAL-FETAL EXCHANGE; PREGNANCY; PREGNANCY COMPLICATIONS;

EID: 70349653063     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e3181b385ba     Document Type: Review

References (107)

1. American College of Obstetricians and Gynecologists. Gestational Diabetes: ACOG. Practice Bulletin No 30. Obstet Gynecol. 2001;98: 525-538.
2. Anonymous. Sulphonylureas in pregnancy. Lancet. 1991;338:1222
3. Greene M. Oral hypoglycemic drugs for gestational diabetes. N Engl J Med. 2000;343:1178-1179.
4. Clark MJ Jr, Sterrett JJ, Carson DC. Diabetes guidelines: a summary and comparison of the recommendations of the American Diabetes Association, Veterans Health Administration, and American Association of Clinical Epidemiologists. Clin Ther. 2000;22:899-910; discussion 898.
5. Clinical Practice Guidelines. Alexandria, VA: American Diabetes Association; 2004.
6. Briggs G. Drugs in Pregnancy and Lactation. Philadelphia, PA: Lippincott; 2005:735.
7. Koren G. Maternal-Fetal Toxicology. 3rd ed. New York, NY: Marcel Dekker; 2001.
8. Garcia-Bournissen F, Feig DS, Koren G. Maternal-fetal transport of hypoglycemic drugs. Clin Pharmacokinet. 2003;42:303-313.
9. Lobstein R, Lalkin A, Koren G. Pharmacokinetic changes during pregnancy and their clinical relevance. Clin Pharmacokinet. 1997;33: 328-343.
10. Chiloiro M, Darconza G, Picciolili E, et al. Gastric emptying and orocecal transit time in pregnancy. J Gastroenterol. 2001;36:538-543.
11. Wong CA, Loffredi M, Ganchiff JN, et al. Gastric emptying of water in term pregnancy. Anesthesiology. 2002;96:1395-1400.
12. Mendenhall HW. Serum protein concentrations in pregnancy: I. Concentration in maternal serum. Am J Obstet Gynecol. 1970;106:388-399.
13. Lund CJ, Donovan JC. Blood volume during pregnancy; significance of plasma and red cell volumes. Am J Obstet Gynecol. 1967;98:394-403.
14. Mano Y, Tsukada H, Kurihara T, et al. Development of dosage design of hepatic metabolizing drugs using serum albumin level in chronic hepatic failure. Biol Pharm Bull. 2006;29:1692-1699.
15. Tracy TS, Venkataramanan R, Glover DD, et al. Temporal changes in drug metabolism (CYP 1A2, CYP 2D6 and CYP3A activity). Am J Obstet Gynecol. 2005;192:633-639.
16. Anderson G. Pregnancy-induced changes in pharmacokinetics. A mechanistic-based approach. Clin Pharmacokinet. 2005;44:989-1008.
17. Dunlop W, Davison JM. Renal haemodynamics and tubular function in human pregnancy. Baillieres Clin Obstet Gynaecol. 1987;1:769-787.
18. Eliott BD, Schenker S, Langer O, et al. Comparative placental transport of oral hypoglycemic agents in humans: a model of human placental drug transfer. Am J Obstet Gynecol. 1994;171:653-660.
19. Frederiksen MC. Physiologic change in pregnancy and their effect on drug disposition. Semin Perinatol. 2001;25:120-123.
20. Koren G. Glyburide and fetal safety: transplacental pharmacokinetic considerations. Reprod Toxicol. 2001;15:227-229.
21. Ganapathy V, Prasad PD, Ganapathy ME, et al. Placental transporters relevant to drug distribution across the maternal-fetal interface. J Pharmacol Exp Ther. 2000;294:413-420.
22. Lynden TW, Robinson JM, Tridandapani S, et al. The Fc receptor for IgG expressed in the villous endothelium of human placenta is Fc gamma RIIb2. J Immunol. 2001;166:3882-3889.
23. Ganapathy V, Prasad PD. Role of transporters in placental transfer of drugs. Toxicol Appl Pharmacol. 2005;207(Suppl 2):381-387.
24. Molsa M, Heikkinen T, Hakkola J, et al. Functional role of Pglycoprotein in the human blood-placental barrier. Clin Pharmacol Ther. 2005;78:118-122.
25. Pollex E, Lubetsky A, Koren G. The role of placental breast cancer resistance protein in the efflux of glyburide across the human placenta. Placenta. 2008;29:743-747.
26. Petrovic V, Wang JH, Piquette-Miller M. Effect of endotoxin on the expression of placental drug transporters and glyburide disposition in pregnant rats. Drug Metab Dispos. 2008;36:1944-1950.
27. Steels JM, Johnstone FD, Hume R, et al. Insulin requirements during pregnancy in women with type 1 diabetes. Obstet Gynecol. 1994;83: 253-258.
28. Jovanovic L, Knopp RH, Brown Z, et al. Declining insulin requirement in the late first trimester of diabetic pregnancy. Diabetes Care. 2001;24: 1130-1136.
29. Gray RS, Cowan P, Steel JM, et al. Insulin action and pharmacokinetics in insulin treated diabetics during the third trimester of pregnancy. Diabet Med. 1984;1:273-278.
30. Bjorklund AO, Adamson UKC, Lins PS, et al. Diminished insulin clearance during late pregnancy in patients with type I diabetes mellitus. Clin Sci. 1998;95:317-323.
31. Kautzky-Willer A, Prager R, Waldhausl W, et al. Pronounced insulin resistance and inadequate beta-cell secretion characterize lean gestational diabetes during and after pregnancy. Diabetes Care. 1997;20: 1717-1723.
32. Challier JC, Haugel S, Desmiazieres V. Effects of insulin on glucose uptake and metabolism in the human placenta. J Clin Endocrinol Metab. 1986;62:803-807.
33. Menon R, Cohen R, Sperling M, et al. Transplacental passage of insulin in pregnant women with insulin-dependent diabetes mellitus: its role in fetal macrosomia. N Engl J Med. 1990;323:309-315.
34. Weiss PA, Kainer F, Purstner P, et al. Anti-insulin antibodies and birth weight in pregnancies complicated by diabetes. Early Hum Dev. 1998; 53:145-154.
35. CarpenterMW, Canick JA, Hogan JW, et al. Amniotic fluid insulin at 14- 20 weeks' gestation: association with later maternal glucose intolerance and birth macrosomia. Diabetes Care. 2001;24:1259-1263.
36. Kimmerle R, Chantelau E. Transplacental passage of insulin [editorial]. N Engl J Med. 1991;324:198-199.
37. Balsells M, Corcoy R, Mauricio D, et al. Insulin antibody response to a short course of human insulin therapy in women with gestational diabetes. Diabetes Care. 1997;20:1172-1175.
38. Howey DC, Bowsher RR, Brunelle RL, et al. Lys (B28), Pro (B29)- human insulin: a rapidly absorbed analog of human insulin. Diabetes. 1994;43:396-402.
39. Holleman F, Hoekstra JB. Insulin lispro. N Engl J Med. 1997;337:176-183.
40. Anderson JH, Brunelle RL, Koivisto VA, et al. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Diabetes. 1997;46:265-270.
41. Jovanovic L, Ilic S, Pettitt DJ, et al. The metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care. 1999;22: 1422-1426.
42. Boskovic R, Feig DS, Derewlany L, et al. Transfer of insulin lispro across the human placenta: in vitro perfusion studies. Diabetes Care. 2003;26:1390-1394.
43. Bhattacharyya A, Brown S, Hughes S, et al. Insulin lispro and regular human insulin in pregnancy. QJM. 2001;94:255-260.
44. Wyatt JW, Frias JL, Hoyme HE, et al. Congenital anomaly rate in offspring of mothers with diabetes treated with insulin lispro during pregnancy. Diabet Med. 2005;22:803-807.
45. Aydin Y, Berker D, Direktor N, et al. Is insulin lispro safe in pregnant women: does it cause any adverse outcomes on infants or mothers? Diabetes Res Clin Pract. 2008;80:444-448.
46. Heinemann L, Kapitza C, Starke AA, et al. Time-action profile of the insulin analog B28Asp. Diabet Med. 1996;13:683-684.
47. Home PD, Lindholm A, Hylleberg B, et al. Improved glycemic control with insulin aspart: a multi-center randomized double-blind crossover trial in type I diabetic patients; UK Insulin Aspart Study Group. Diabetes Care. 1998;21:1904-1909.
48. Home PD, Barriocanal L, Lindholm A. Comparative pharmacokinetics and pharmacodynamics of the novel rapid-acting insulin analog, insulin aspart in healthy volunteers. Eur J Clin Pharmacol. 1999;55:199-203.
49. Jovanovic L, Howard C, Pettitt D, et al. Insulin aspart vs regular human insulin in basal/bolus therapy for patients with gestational diabetes mellitus: safety and efficacy. Diabetologia. 2005;48:A317-A318.
50. McCance DR, Damm P, Mathiesen ER, et al. Evaluation of insulin antibodies and placental transfer of insulin aspart in pregnant women with type 1 diabetes mellitus. Diabetologia. 2008;51:2141-2143.
51. Mathiesen E, Kinsley B, McCance D, et al. Maternal hypoglycemia and glycemic control in pregnancy: a randomized trial comparing insulin aspart with human insulin in 322 subjects with type 1 diabetes. Diabetes Care. 2007;30:771-776.
52. Pettitt DJ, Ospina P, Howard C, et al. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med. 2007;10: 1129-1135.
53. Homko CJ, Reece AE. Insulins and oral hypoglycemic agents in pregnancy. J Matern Fetal Neonatal Med. 2006;19:679-686.
54. Wooldrenrink JM, Van Loon AJ, Storms F, et al. Use of insulin glargine during pregnancy in seven type 1 diabetic women. Diabetes Care. 2005; 28:2394-2395.
55. Di Cianni G, Torlone E, Lencioni C, et al. Perinatal outcomes associated with the use of glargine during pregnancy. Diabet Med. 2008;25:993-996.
56. Gallen IW, Jaap A, Roland JM, et al. Survey of glargine use in 115 pregnant women with type I diabetes. Diabet Med. 2008;25:165-169.
57. Imbergamo MP, Amato MC, Sciortino G, et al. Use of glargine in pregnant women with type 1 diabetes mellitus: a case-control study. Clin Ther. 2008;30:1476-1484.
58. Price N, Bartlett C, Gillmer MD. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG. 2007;114:453-457.
59. Whittingham JL, Havelund S, Jonassen L. Crystal structure of prolonged-acting insulin with albumin-binding properties. Biochemistry. 1997;36:2826-2831.
60. Becker RH, Frick AD. Clinical pharmacokinetics and pharmacodynamics of insulin glulisine. Clin Pharmacokinet. 2008;47:7-20.
61. Lapolla A, Dalfra MG, Fedele D. Insulin therapy in pregnancy complicated by diabetes: are insulin analogs a new tool? Diabetes Metab Res Rev. 2005;21:241-252.
62. Vaughan NJA, Oakley NW. Treatment of diabetes in pregnancy. Clin Obstet Gynecol. 1986;13:291-306.
63. Nachum Z, Ben-Shlomo I, Weiner E, et al. Twice daily versus four times daily insulin dose regimens for diabetes in pregnancy: randomized controlled trial. BMJ. 1999;319:1223-1227.
64. Elliot BD, Langer O, Schenker S, et al. Insignificant transfer of glyburide occurs across the human placenta. Am J Obstet Gynecol. 1991;165:807-812.
65. Mollar-Puchades MA, Martin-Cortes A, Perez-Calvo A, et al. Use of repaglinide on a pregnant woman during embryogenesis. Diabetes Obes Metab. 2007;9:146-147.
66. Yaris F, Yaris E, Kadioglu M, et al. Normal pregnancy outcome following inadvertent exposure to rosiglitazone, gliclazide, and atorvastatin in a diabetic and hypertensive woman. Reprod Toxicol. 2004;18:619-621.
67. Napoli A, Ciampa F, Colatrella A, et al. Use of repaglinide during the first weeks of pregnancy in two type 2 diabetic women. Diabetes Care. 2006;29:2326-2327.
68. Kolagasi O, Sari F, Akar M, et al. Normal pregnancy and healthy child after continued exposure to gliclazide and ramipril during pregnancy. Ann Pharmacother. 2009;43:147-149.
69. Moore T. Glyburide for the treatment of gestational diabetes: a critical appraisal. Diabetes care. 2007;30:S209-S213.
70. Ben-Haroush A, Yogev Y, Chen R, et al. The postprandial glucose profile in the diabetic pregnancy. Am J Obstet Gynecol. 2004;191:576-581.
71. Rydberg T, Jönsson A, Karlsson MO, et al. Concentration-effect relations of glibenclamide and its active metabolites in man: modelling of pharmacokinetics and pharmacodynamics. Br J Clin Pharmacol. 1997;43:373-381.
72. Iwakawa S, Miyashita K, Hashimoto Y, et al. Effect of glimepiride and glibenclamide on S-warfarin 7-hydroxylation by human liver microsomes, recombinant human CYP2C9.1 and CYP2C9.3. Biol Pharm Bull. 2006;29:1983-1985.
73. Kim KA, Park JY. Inhibitory effect of glyburide on human cytochrome P450 isoform in human liver microsomes. Drug Metab Dispos. 2003;31: 1090-1092.
74. Juurlink DN, Mamdani M, Kopp A, et al. Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA. 2003;289:1652-1658.
75. Van Gierbergen PL, Treiber A, Clozel M, et al. In vivo and in vitro studies exploring the pharmacokinetic interaction between bosentan, a dual endothelin receptor antagonist, and glyburide. Clin Pharmacol Ther. 2002;71:253-262.
76. Kramer J, Feig D, Klein J, et al. The transport of glyburide in the human placenta: implication for treatment of gestational diabetes. Am J Obstet Gynecol. 2006;195:270-274.
77. Langer O, Conway DL, Berkus MD, et al. Comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med. 2000; 343:1134-1138.
78. Moretti ME, Rezvani M, Koren G. Safety of glyburide for gestational diabetes: a meta-analysis of pregnancy outcomes. Ann Pharmacother. 2008;42:483-490.
79. Hebert M, Naraharisetti S, Ma X, et al. Are we guessing glyburide dosage in the treatment of gestational diabetes (GDM)? The pharmacological evidence for better clinical practice [abstract]. Presented at: The Society for Maternal-Fetal Medicine (SMFM); January 28-February 2, 2008; Dallas, TX.
80. Gedeon C, Anger G, Piquette-Miller M, et al. Breast cancer resistance protein: mediating the transplacental transfer of glyburide across the human placenta. Placenta. 2008;29:39-43.
81. Golstein PE, Boom A, Van Geffel J, et al. P-glycoprotein inhibition by glibenclamide and related compounds. Pflugers Arch. 1999;437:652-660.
82. Zhou L, Naraharisetti SB, Wang H, et al. The breast cancer resistance protein (Bcrp 1/A bcg2) limits fetal distribution of glybuide in pregnant mouse: an Obstetric-Fetal Pharmacology Research Unit Network and University of Washington Specialized Center of Research study. Mol Pharmacol. 2008;73:949-959.
83. Abraham EH, Shrivastav B, Salikhova AY, et al. Cellular and biophysical evidence for interactions between adenosine triphosphate and Pglycoprotein substrates: functional implications for adenosine triphosphate/ drug co-transport in P-glycoprotein over-expressing tumor cells and in P-glycoprotein low-level expressing erythrocytes. Blood Cells Mol Dis. 2001;27:181-200.
84. Ushigome F, Takanaga H, Matsuo H, et al. Human placental transport of vinblastine, vincristine, digoxin and progesterone: contribution of P-glycoprotein. Eur J Pharmacol. 2000;408:1-10.
85. Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs. 2003;63:1879-1894.
86. Glueck CJ, Goldenberg N, Pranikoff J, et al. Height, weight, and motorsocial development during the first 18 months of life in 126 infants born to 109 mothers with poly-cystic ovarian syndrome who conceived on and continued metformin through pregnancy. Hum Reprod. 2004;19:1323-1330.
87. Hsieh CH, He CT, Lee CH, et al. Both slow-release and regular releaseform metformin improve glycemic control without altering plasma visfatin level in patients with type 2 diabetes mellitus. Metabolism. 2007; 56:1087-1092.
88. Rowan J, Hague W, Gao W, et al. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008;358:2003-2015.
89. Jakubowicz DJ, Iuorno MJ, Jakubowicz S, et al. Effects of metformin on early pregnancy loss in the polycystic ovary syndrome. J Clin Endocrinol Metab. 2002;87:524-529.
90. Glueck CJ, Wang P, Kobayashi S, et al. Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. Fertil Steril. 2002;77:520-525.
91. Gilbert C, Valois M, Koren G. Pregnancy outcome after first trimester exposure to metformin: a mete-analysis. Fertil Steril. 2006;86:658-663. (Pubitemid 44307028)
92. National Institute for Health and Clinical Excellence. Diabetes in Pregnancy: Management of Diabetes and Its Complications From Pre- Conception to the Postnatal Period. London, United Kingdom: NICE; 2008.
93. Taylor R, Cooper BG, Catalano C, et al. The effect of intravenous metformin on glucose metabolism during hyperglycaemia in type 2 diabetes. Diabet Med. 1992;9:61-65.
94. Scheen AJ. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 1996;30:359-371.
95. Sambol NC, Brookes LG, Chiang J, et al. Food intake and dosage level, but not table vs solution dosage form, affects the absorption of metformin HCl in man. Br J Clin Pharmacol. 1996;42:510-512.
96. Marathe PH, Wen Y, Norton J, et al. Effect of altered gastric emptying and gastrointestinal motility on metformin absorption. Br J Clin Pharmacol. 2000;50:325-332.
97. Parry E, Shields R, Turnbull AC. Transit time in the small intestine in pregnancy. J Obstet Gynaecol Br Commonw. 1970;77:900-901.
98. Charles B, Norris R, Xiano X, et al. Population pharmacokinetics of metformin in late pregnancy. Ther Drug Monit. 2006;28:67-72.
99. Hughes RC, Gardiner SJ, Begg EJ, et al. Effects of pregnancy on the pharmacokinetics of metformin. Diabet Med. 2006;23:323-326.
100. Mannucci E, Monami M, Di Bari M, et al. Cardiac safety profile of rosiglitazone. A comprehensive meta-analysis of randomized clinical trials. Int J Cardiol. March 26, 2009 [Epub Ahead of Print].
101. Chan LY, Yeung JH, Lau TK, et al. Placental transfer of rosiglitazone in the first trimester of human pregnancy. Fertil Steril. 2005;83:955-958.
102. Haddad GF, Jodicke C, Thomas MA, et al. Case series of rosiglitazone used during the first trimester of pregnancy. Reprod Toxicol. 2008;26: 183-184.
103. de Veciana M, Trail PA, Lau TK, et al. A comparison of oral acarbose and insulin in women with gestational diabetes. Obstet Gynecol. 2002; 99(Suppl):5S.
104. Coustan DR. Pharmacological management of gestational diabetes. Diabetes Care. 2007;30:S206-S208.
105. Hiles RA, Bawdon RE, Petrella EM. Ex vivo human placental transfer of the peptides pramlintide and exenatide. Hum Exp Toxicol. 2003;22: 623-628.
106. Strack TR. Inhaled human insulin. Drugs Today. 2006;42:207-221.
107. Health Canada. New Restrictions on the Use of Rosiglitazone Products Due to Cardiac Safety Concerns. Ottowa: Health Canada; 2007.