دورية أكاديمية
Population pharmacokinetics of esomeprazole in patients with preterm preeclampsia.
| العنوان: | Population pharmacokinetics of esomeprazole in patients with preterm preeclampsia. |
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| المؤلفون: | Gebreyesus MS; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa., Decloedt EH; Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University and Tygerberg Hospital, Stellenbosch, South Africa., Cluver CA; Department of Obstetrics and Gynaecology, Stellenbosch University and Tygerberg Hospital, Stellenbosch, South Africa., Hunfeld NGM; Department of Pharmacy and Intensive Care, Erasmus University Rotterdam, Rotterdam., Helgadóttir H; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Iceland, Reykjavik, Iceland., Björnsson ES; Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Iceland, Reykjavik, Iceland., Wasmann RE; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa., Denti P; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. |
| المصدر: | British journal of clinical pharmacology [Br J Clin Pharmacol] 2022 Oct; Vol. 88 (10), pp. 4639-4645. Date of Electronic Publication: 2022 Jun 03. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Oxford : Wiley-Blackwell Original Publication: London, Macmillan Journals Ltd. |
| مواضيع طبية MeSH: | Esomeprazole* , Pre-Eclampsia*/drug therapy, Cytochrome P-450 CYP2C19/genetics ; Female ; Humans ; Infant, Newborn ; Pregnancy ; Proton Pump Inhibitors |
| مستخلص: | Esomeprazole is a proton pump inhibitor being investigated for treatment of preeclampsia. Esomeprazole pharmacokinetics during pregnancy are unknown. We used data from 10 pregnant participants with preterm preeclampsia, and 49 non-pregnant participants to develop a population pharmacokinetic model of esomeprazole. A two-compartment model described the data well. In pregnant participants after single dose, clearance was 42.2% (14.9-61.6%) lower compared to non-pregnant, most likely due to inhibition of CYP2C19. In non-pregnant participants after repeated dosing, clearance was 54.9% (48.2-63.5%) lower in extensive metabolizers and bioavailability was 33% (10.0-52.0%) higher compared to single dosing, which could be due to autoinhibition of CYP2C19. During pregnancy, the CYP2C19 autoinhibition effect with repeated dosing is expected to lead to much lower increase in exposure compared to non-pregnant individuals, since CYP2C19 is already inhibited due to pregnancy. (© 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.) |
| References: | Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108(3):308-328. doi:10.1038/ajg.2012.444. Andersson T, Hassan-Alin M, Hasselgren G, Röhss K, Weidolf L. Pharmacokinetic studies with esomeprazole, the (S)-isomer of omeprazole. Clin Pharmacokinet. 2001;40(6):411-426. doi:10.2165/00003088-200140060-00003. Dean L. Esomeprazole therapy and CYP2C19 genotype drug class: proton pump inhibitors. In: Pratt VM, Scott SA, Pirmohamed M, et al., eds. Medical Genetics Summaries. Bethesda, MD: National Center for Biotechnology Information; 2019. Klotz U. Clinical impact of CYP2C19 polymorphism on the action of proton pump inhibitors: a review of a special problem. Int J Clin Pharmacol Ther. 2006;44(7):297-302. doi:10.5414/CPP44297. Andersson T, Röhss K, Bredberg E, Hassan-Alin M. Pharmacokinetics and pharmacodynamics of esomeprazole, the S-isomer of omeprazole. Aliment Pharmacol Ther. 2001;15(10):1563-1569. doi:10.1046/j.1365-2036.2001.01087.x. Anderson GD. Pregnancy-induced changes in pharmacokinetics: a mechanistic-based approach. Clin Pharmacokinet. 2005;44(10):989-1008. doi:10.2165/00003088-200544100-00001. Chappell LC, Cluver CA, Kingdom J, Tong S. Pre-eclampsia. Lancet. 2021;398(10297):341-354. doi:10.1016/S0140-6736(20)32335-7. Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009;33(3):130-137. doi:10.1053/j.semperi.2009.02.010. Machano MM, Joho AA. Prevalence and risk factors associated with severe pre-eclampsia among postpartum women in Zanzibar: a cross-sectional study. BMC Public Health. 2020;20(1):1-10. doi:10.1186/s12889-020-09384-z. Tong S, Kaitu'u-Lino TJ, Hastie R, Brownfoot F, Cluver C, Hannan N. Pravastatin, proton-pump inhibitors, metformin, micronutrients, and biologics: new horizons for the prevention or treatment of preeclampsia. Am J Obstet Gynecol. 2022;226(2):S1157-S1170. doi:10.1016/j.ajog.2020.09.014. De Silva M, Brownfoot F, Hannan NJ, et al. A systematic review of proton pump inhibitors for the prevention and treatment of preeclampsia and gestational hypertension. Open J Obstet Gynecol. 2019;9(1):21-28. doi:10.4236/ojog.2019.91003. Onda K, Tong S, Beard S, et al. Proton pump inhibitors decrease soluble fms-like tyrosine kinase-1 and soluble endoglin secretion, decrease hypertension, and rescue endothelial dysfunction. Hypertension. 2017;69(3):457-468. doi:10.1161/HYPERTENSIONAHA.116.08408. Cluver CA, Hannan NJ, van Papendorp E, et al. Esomeprazole to treat women with preterm preeclampsia: a randomized placebo controlled trial. Am J Obstet Gynecol. 2018;219(4):388.e1-388.e17. doi:10.1016/j.ajog.2018.07.019. Hunfeld NG, Touw DJ, Mathot RA, et al. A comparison of the acid-inhibitory effects of esomeprazole and pantoprazole in relation to pharmacokinetics and CYP2C19 polymorphism. Aliment Pharmacol Ther. 2010;31(1):150-159. doi:10.1111/j.1365-2036.2009.04150.x. Helgadóttir H, Lund SH, Gizurarson S, Waldum H, Björnsson ES. Pharmacokinetics of single and repeated oral doses of esomeprazole and gastrin elevation in healthy males and females. Scand J Gastroenterol. 2021;56(2):128-136. doi:10.1080/00365521.2020.1859610. Keizer RJ, Karlsson MO, Hooker A. Modeling and simulation workbench for NONMEM: tutorial on Pirana, PsN, and Xpose. CPT Pharmacometrics Syst Pharmacol. 2013;2(6):1-9. doi:10.1038/psp.2013.24. Beal SL. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn. 2001;28(5):481-504. doi:10.1023/A:1012299115260. Keizer RJ, Zandvliet AS, Beijnen JH, Schellens JHM, Huitema ADR. Performance of methods for handling missing categorical covariate data in population pharmacokinetic analyses. AAPS J. 2012;14(3):601-611. doi:10.1208/s12248-012-9373-2. Strom CM, Goos D, Crossley B, et al. Testing for variants in CYP2C19: population frequencies and testing experience in a clinical laboratory. Genet Med. 2012;14(1):95-100. doi:10.1038/gim.0b013e3182329870. Alexander SPH, Fabbro D, Kelly E, et al. The Concise Guide to PHARMACOLOGY 2021/22: Enzymes. Br J Pharmacol. 2021;178(S1):S313-S411. doi:10.1111/bph.15542. Jeong H. Altered drug metabolism during pregnancy: hormonal regulation of drug-metabolizing enzymes. Expert Opin Drug Metab Toxicol. 2010;6(6):689-699. doi:10.1517/17425251003677755. Andersson T, Andren K, Cederberg C, Lagerstrom P, Lundborg P, Skanberg I. Pharmacokinetics and bioavailability of omeprazole after single and repeated oral administration in healthy subjects. Br J Clin Pharmacol. 1990;29(5):557-563. doi:10.1111/j.1365-2125.1990.tb03679.x. Poweleit EA, Cinibulk MA, Novotny SA, Wagner-schuman M, Ramsey LB, Strawn JR. Selective serotonin reuptake inhibitor pharmacokinetics during pregnancy: clinical and research implications. Front Pharmacol. 2022;13:1-8. doi:10.3389/fphar.2022.833217. Nagase M, Shimada H, Nii M, et al. Population pharmacokinetic analysis of esomeprazole in Japanese subjects with various CYP2C19 phenotypes. J Clin Pharm Ther. 2020;45(5):1030-1038. doi:10.1111/jcpt.13129. Liu D, Yang H, Jiang J, et al. Pharmacokinetic and pharmacodynamic modeling analysis of intravenous esomeprazole in healthy volunteers. J Clin Pharmacol. 2016;56(7):816-826. doi:10.1002/jcph.733. Standing JF, Sandström M, Andersson T, Rohss K, Karlsson MO. Population pharmacokinetic modelling of esomeprazole nonlinearity. Accessed May 24, 2022. https://www.page-meeting.org/?abstract=1577. Shin JM, Kim N. Pharmacokinetics and pharmacodynamics of the proton pump inhibitors. J Neurogastroenterol Motil. 2013;19(1):25-35. doi:10.5056/jnm.2013.19.1.25. El Rouby N, Lima JJ, Johnson JA. Proton pump inhibitors: from CYP2C19 pharmacogenetics to precision medicine. Expert Opin Drug Metab Toxicol. 2018;14(4):447-460. doi:10.1080/17425255.2018.1461835. Hassan-Alin M, Andersson T, Bredberg E, Rohss K. Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects. Eur J Clin Pharmacol. 2000;56(9-10):665-670. doi:10.1007/s002280000206. |
| فهرسة مساهمة: | Keywords: early-onset preeclampsia; modelling; pharmacokinetics |
| المشرفين على المادة: | 0 (Proton Pump Inhibitors) EC 1.14.14.1 (Cytochrome P-450 CYP2C19) N3PA6559FT (Esomeprazole) |
| تواريخ الأحداث: | Date Created: 20220523 Date Completed: 20220913 Latest Revision: 20221003 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1111/bcp.15416 |
| PMID: | 35599445 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1365-2125 |
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| DOI: | 10.1111/bcp.15416 |