Journal
CLINICAL PHARMACOLOGY & THERAPEUTICS
Volume 85, Issue 6, Pages 607-614Publisher
WILEY
DOI: 10.1038/clpt.2009.5
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Funding
- National Institutes of Health (NIH)/National Institute of Child Health and Human [U10HD047892, U10HD047905, U10HD047890, U10HD047891]
- NIH/National Center for Research Resources [UL1RR025014, M01RR00037, M01RR023942, P41EB001975]
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Glyburide's pharmacokinetics (PK) and pharmacodynamics have not been studied in women with gestational diabetes mellitus (GDM). The objective of this study was to assess steady-state PK of glyburide, as well as insulin sensitivity, beta-cell responsivity, and overall disposition indices after a mixed-meal tolerance test (MMTT) in women with GDM (n = 40), nonpregnant women with type 2 diabetes mellitus (T2DM) (n = 26), and healthy pregnant women (n = 40, MMTT only). At equivalent doses, glyburide plasma concentrations were similar to 50% lower in pregnant women than in nonpregnant subjects. The average umbilical cord/maternal plasma glyburide concentration ratio at the time of delivery was 0.7 +/- 0.4. Insulin sensitivity was approximately fivefold lower in women with GDM as compared with healthy pregnant women. Despite comparable beta-cell responsivity indices, the average beta-cell function corrected for insulin resistance was more than 3.5-fold lower in women with glyburide-treated GDM than in healthy pregnant women. Women with GDM in whom glyburide treatment has failed may benefit from alternative medication or dosage escalation; however, fetal safety should be kept in mind.
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