Pharmacokinetics of 17-hydroxyprogesterone caproate in multifetal gestation - 19/08/11

Doi : 10.1016/j.ajog.2011.03.028

Steve N. Caritis, MD ^a, Shringi Sharma, PhD ^c, Raman Venkataramanan, PhD ^b,^c, Dwight J. Rouse, MD ^d, Alan M. Peaceman, MD ^e, Anthony Sciscione, DO ^f, Catherine Y. Spong, MD ^q, Michael W. Varner, MD ^g, Fergal D. Malone, MD ^h, Jay D. Iams, MD ⁱ, Brian M. Mercer, MD ^j, John M. Thorp, MD ^k, Yoram Sorokin, MD ^l, Marshall Carpenter, MD ^m, Julie Lo, MD ⁿ, Susan Ramin, MD ^o, Margaret Harper, MD, MS ^p
Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network^r
^a Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA
^b Department of Pathology, School of Medicine, University of Pittsburgh, Pittsburgh, PA
^c Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA
^d Departments of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL
^e Northwestern University, Chicago, IL
^f Drexel University, Philadelphia, PA
^g University of Utah, Salt Lake City, UT
^h Columbia University, New York, NY
ⁱ The Ohio State University, Columbus, OH
^j Case Western Reserve University, Cleveland, OH
^k University of North Carolina, Chapel Hill, NC
^l Wayne State University, Detroit, MI
^m Brown University, Providence, RI
ⁿ University of Texas Southwestern Medical Center, Dallas, TX
^o University of Texas Health Science Center at Houston, Houston, TX
^p Wake Forest University Health Sciences, Winston-Salem, NC
^q Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD
^r Other members of the Eunice Kennedy Shriver National Institute for Child Health and Human Development Maternal-Fetal Medicine Units Network are listed in the Acknowledgments.

Résumé

Objective

The purpose of this study was to define the pharmacokinetic parameters of 17-hydroxyprogesterone caproate (17-OHPC) in multifetal gestation.

Study Design

Blood was obtained at 24-28 weeks' gestation and at 32–35 weeks gestation in 97 women with twin and 26 women with triplet gestation who were receiving 17-OHPC. Six of the women with twins had daily blood sampling for 7 days between 24 and 28 weeks' gestation, and pharmacokinetic parameters were estimated with the use of noncompartmental analysis. Modeling was applied to estimate the population parameters and to simulate various treatment scenarios.

Results

The apparent half-life of 17-OHPC was 10 days. Body mass index significantly impacted 17-OHPC concentrations, but fetal number and parity did not. Apparent clearance was significantly greater in African American than in white women (P = .025).

Conclusion

This is the first pharmacokinetic analysis of 17-OHPC in pregnant women. Determination of half-life, covariates that affect plasma 17-OHPC concentrations, and the modeling of drug behavior provide insights into this drug's pharmacologic properties during multifetal pregnancy.

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Key words : 17-hydroxyprogesterone caproate, multifetal gestation, pharmacokinetics

Plan

Materials and Methods

Patients and drug administration

Pharmacokinetic sampling schedule

Sample analysis

Noncompartmental pharmacokinetic analysis

Population pharmacokinetic analysis

Statistical analysis

Results

Pharmacokinetics (intensive sampling)

Steady-state concentration

Impact of BMI and other covariates on 17-OHPC concentrations

Impact of fetal number of 17-OHPC concentration

Population pharmacokinetics

Plasma concentration simulations

Comment

	Cite this article as: Caritis SN, Sharma S, Venkataramanan R, et al. Pharmacokinetics of 17-hydroxyprogesterone caproate in multifetal gestation. Am J Obstet Gynecol 2011;205:40.e1-8.
	Reprints not available from the authors.
	Supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD27869, HD21410, HD40512, HD34136, HD34208, HD40485, HD27915, HD40544, HD40560, HD27917, HD40500, HD34116, HD40545, HD27860, HD36801) and does not necessarily represent the official views of the National Institute of Child Health and Human Development or the National Institutes of Health.

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Vol 205 - N° 1

P. 40.e1-40.e8 - juillet 2011 Retour au numéro

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Pharmacokinetics of 17-hydroxyprogesterone caproate in multifetal gestation - 19/08/11

Résumé

Objective

Study Design

Results

Conclusion

Plan

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