Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: A pilot randomized controlled trial

American Journal of Obstetrics and Gynecology

Volumn 214, Issue 6, 2016, Pages 720.e1-720.e17

  Costantine, Maged M ^a   Cleary, Kirsten ^b   Hebert, Mary F ^c   Ahmed, Mahmoud S ^a   Brown, Linda M ^f   Ren, Zhaoxia ^g   Easterling, Thomas R ^c   Haas, David M ^e   Haneline, Laura S ^e   Caritis, Steve N ^d   Venkataramanan, Raman ^d   West, Holly ^a   D'Alton, Mary ^b   Hankins, Gary ^a  

^a University of Texas Medical Branch School of Medicine   (United States)

^b Och Spine at New York Presbyterian Hospitals   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^e INDIANA UNIVERSITY   (United States)

^f RTI INTERNATIONAL   (United States)

^g EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

Author keywords

angiogenic; pharmacokinetics; pravastatin; preeclampsia; safety

Indexed keywords

CHOLESTEROL; LOW DENSITY LIPOPROTEIN; PLACEBO; PRAVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ADULT; AREA UNDER THE CONCENTRATION TIME CURVE; AREA UNDER THE CURVE; ARTICLE; CHILD DEATH; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; COMPARATIVE STUDY; CONGENITAL MALFORMATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE EXACERBATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG SAFETY; EVOKED BRAIN STEM AUDITORY RESPONSE; FAINTNESS; FATIGUE; FEMALE; FEVER; FLATULENCE; FLU LIKE SYNDROME; FOLLOW UP; GESTATIONAL AGE; HEADACHE; HEARTBURN; HIGH RISK PATIENT; HUMAN; INFLUENZA; LIMIT OF QUANTITATION; LIVER INJURY; LOW DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MIGRAINE; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; NAUSEA; ORAL CLEARANCE; OUTCOME ASSESSMENT; OUTCOME VARIABLE; PHARMACOKINETIC PARAMETERS; PHASE 1 CLINICAL TRIAL; PILOT STUDY; PREECLAMPSIA; PREGNANT WOMAN; PREMATURE LABOR; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RENAL CLEARANCE; RHABDOMYOLYSIS; RISK BENEFIT ANALYSIS; SIDE EFFECT; STEADY STATE; SWELLING; THORAX PAIN; TIME TO MAXIMUM PLASMA CONCENTRATION; UMBILICAL CORD BLOOD; VAGINA BLEEDING; VOMITING; WHEEZING; BIRTH WEIGHT; BLOOD; CHEMISTRY; CLINICAL TRIAL; FETUS BLOOD; FIRST TRIMESTER PREGNANCY; HIGH RISK PREGNANCY; NEWBORN; PRE-ECLAMPSIA; PREGNANCY; SECOND TRIMESTER PREGNANCY;

ADULT; BIRTH WEIGHT; CHOLESTEROL; DOUBLE-BLIND METHOD; FEMALE; FETAL BLOOD; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; INFANT, NEWBORN; PILOT PROJECTS; PRAVASTATIN; PRE-ECLAMPSIA; PREGNANCY; PREGNANCY TRIMESTER, FIRST; PREGNANCY TRIMESTER, SECOND; PREGNANCY, HIGH-RISK;

EID: 84975677838     PISSN: 00029378     EISSN: 10976868     Source Type: Journal    
DOI: 10.1016/j.ajog.2015.12.038     Document Type: Article

References (40)

1. American College of Obstetricians and Gynecologists Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy Obstet Gynecol 122 2013 1122 1131
2. S. Baumwell, and S.A. Karumanchi Preeclampsia: clinical manifestations and molecular mechanisms Nephron Clin Pract 106 2007 c72 c81
3. M.L. Mongraw-Chaffin, P.M. Cirillo, and B.A. Cohn Preeclampsia and cardiovascular disease death: prospective evidence from the child health and development studies cohort Hypertension 56 2010 166 171
4. J.R. Barton, and B. Sibai Prediction and prevention of recurrent preeclampsia Obstet Gynecol 112 2008 359
5. S. Hernández-DIaz, S. Toh, and S. Cnattingius Risk of pre-eclampsia in first and subsequent pregnancies: prospective cohort study BMJ 338 2009 b2255
6. B.C. Young, R.J. Levine, and S.A. Karumanchi Pathogenesis of preeclampsia Annu Rev Pathol 5 2010 173 192
7. W. Ramma, and A. Ahmed Is inflammation the cause of preeclampsia? Biochem Soc Trans 39 2011 1619 1627
8. G.K. Hansson Inflammation, atherosclerosis, and coronary artery disease N Engl J Med 352 2005 1685 1695
9. L.M. Askie, L. Duley, D.J. Henderson-Smart, and L.A. Stewart PARIS Collaborative Group. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data Lancet 369 2007 1791 1798
10. E.J. Mills, B. Rachlis, P. Wu, P.J. Devereaux, P. Arora, and D. Perri Primary prevention of cardiovascular mortality and events with statin treatments: a network meta-analysis involving more than 65,000 patients J Am Coll Cardiol 52 2008 1769 1781
11. J.J. Brugts, T. Yetgin, S.E. Hoeks, and et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trials BMJ 338 2009 b2376
12. M. Cudmore, S. Ahmad, B. Al-Ani, and et al. Negative regulation of soluble Flt-1 and soluble endoglin release by heme oxygenase-1 Circulation 115 2007 1789 1797
13. M. Costantine, E. Tamayo, E. Bytautiene, and et al. Using pravastatin to improve the vascular reactivity in a mouse model of soluble Fms-like tyrosine kinase-1-induced preeclampsia Obstet Gynecol 116 2010 114 120
14. K.A. Fox, M. Longo, E. Tamayo, and et al. Effects of pravastatin on mediators of vascular function in a mouse model of soluble Fms-like tyrosine kinase-1-induced preeclampsia Am J Obstet Gynecol 205 2011 366.e1 366.e5
15. A. Ahmed, J. Singh, Y. Khan, S.V. Seshan, and G. Girardi A new mouse model to explore therapies for preeclampsia PLoS One 5 10 2010 e13663
16. J. Singh, A. Ahmed, and G. Girardi Role of complement component C1q in the onset of preeclampsia in mice Hypertension 58 2011 716 724
17. K. Kumasawa, M. Ikawa, H. Kidoya, and et al. Pravastatin induces placental growth factor and ameliorates preeclampsia in a mouse model Proc Natl Acad Sci USA 108 2011 1451 1455
18. A.F. Saad, T. Kechichian, H. Yin, and et al. Effects of pravastatin on angiogenic and placental hypoxic imbalance in a mouse model of preeclampsia Rep Sci 21 2014 138 145
19. M.M. Costantine, K. Cleary for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network Pravastatin for the prevention of preeclampsia in high risk pregnant women Obstet Gynecol 121 2013 349 353
20. American College of Obstetricians and Gynecologists Diagnosis and management of preeclampsia and eclampsia. ACOG Practice bulletin Obstet Gynecol 99 2002 159 167
21. R. Edison, and M. Muenke Mechanistic and epidemiologic considerations in the evaluation of adverse birth outcomes following gestational exposure to statins Am J Med Genet 131A 2004 287
22. B. Ofori, E. Rey, and A. Berard Risk of congenital anomalies in pregnant users of statin drugs Br J Clin Pharmacol 64 2007 496
23. N. Taguchi, E.T. Rubin, A. Hosokawa, and et al. Prenatal exposure to HMG-CoA reductase inhibitor: effects on fetal and neonatal outcomes Reprod Toxicol 26 2008 175
24. E.E. Petersen, A.A. Mitchell, J.C. Carey, and et al. Maternal exposure to statins and risk for birth defects Am J Med Genet 146A 2008 2701 2705
25. U. Winterfeld, A. Allignol, A. Panchaud, and et al. Pregnancy outcome following maternal exposure to statins: a multicentre prospective study Br J Obstet Gynaecol 120 2013 463 471
26. B.T. Bateman, S. Hernandez-Diaz, M.A. Fischer, and et al. Statins and congenital malformations: Cohort study BMJ 350 2015 h1035
27. L.A. Woollett Maternal cholesterol in fetal development: transport of cholesterol from the maternal to the fetal circulation Am J Clin Nutr 82 2005 1155 1161
28. M. Ethier-Chiasson, A. Duchesne, J.C. Forest, and et al. Influence of maternal lipid profile on placental protein expression of LDLr and SR-BI Biochem Biophys Res Commun 359 2007 8 14
29. M.A.1 Pfeffer, A. Keech, F.M. Sacks, and et al. Safety and tolerability of pravastatin in long-term clinical trials: prospective Pravastatin Pooling (PPP) Project Circulation 105 2002 2341 2346
30. T. Hatanaka Clinical pharmacokinetics of pravastatin: mechanisms of pharmacokinetic events Clin Pharmacokinet 39 2000 397 412
31. J. Zarek, M.K. DeGorter, A. Lubetsky, and et al. The transfer of pravastatin in the dually perfused human placenta Placenta 34 2013 719 721
32. T.N. Nanovskaya, S.L. Patrikeeva, J. Paul, M. Costantine, G.D.V. Hankins, and M.S. Ahmed Transplacental transfer and distribution of pravastatin Am J Obstet Gynecol 209 2013 373.e1 373.e5
33. S.M. Singhvi, H.Y. Pan, R.A. Morrison, and D.A. Willard Disposition of pravastatin sodium, a tissue-selective HMG-CoA reductase inhibitor, in healthy subjects Br J Clin Pharmacol 29 1990 239 243
34. K. Ogawa, S. Hasegawa, Y. Udaka, K. Nara, S. Iwai, and K. Oguchi Individual difference in the pharmacokinetics of a drug, pravastatin, in healthy subjects J Clin Pharmacol 43 2003 1268 1273
35. M. Hasegawa, H. Kusuhara, D. Sugiyama, and et al. Functional involvement of rat organic anion transporter 3 (rOAT3; Slc22a8) in the renal uptake of organic anions J Pharmacol Exp Ther 300 2002 746 753
36. X. Zhang, D.I. Vernikovskaya, X. Wang, and et al. Quantitative determination of pravastatin and its metabolite 3α-hydroxy pravastatin in plasma and urine of pregnant patients by LC-MS/MS Biomed Chromatogr 30 2016 548 554
37. H.Y. Pan Clinical pharmacology of pravastatin, a selective inhibitor of HMG-CoA reductase Eur J Clin Pharmacol 40 Suppl 1 1991 S15 S18
38. S.M. Singhvi, H.Y. Pan, R.A. Morrison, and et al. Disposition of pravastatin sodium, a tissue-selective HMG-CoA reductase inhibitor, in healthy subjects Br J Clin Pharmacol 29 1990 239 243
39. American College of Obstetricians and Gynecologists Diagnosis and management of preeclampsia and eclampsia. ACOG Practice bulletin no. 33 Obstet Gynecol 99 2002 159 167
40. American College of Obstetricians and Gynecologists Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy Obstet Gynecol 122 2013 1122 1131