Lack of clinical pharmacodynamic and pharmacokinetic drug-drug interactions between warfarin and the antisense oligonucleotide mipomersen

Journal of Cardiovascular Pharmacology

Volumn 64, Issue 2, 2014, Pages 164-171

  Li, Zhaoyang ^a   Hard, Marjie L ^a   Grundy, John S ^b   Singh, Tejdip ^a   Von Moltke, Lisa L ^a   Boltje, Ingrid ^a  

^a GENZYME CORPORATION   (United States)

^b ISIS PHARMACEUTICALS   (United States)

Author keywords

drug drug interactions; homozygous familial hypercholesterolemia; mipomersen; pharmacokinetics,pharmacodynamics; warfarin

Indexed keywords

ANTISENSE OLIGODEOXYNUCLEOTIDE; MIPOMERSEN; OLIGONUCLEOTIDE; WARFARIN;

ADOLESCENT; ADULT; CLINICAL TRIAL; DRUG INTERACTION; FEMALE; HUMAN; HYPERLIPOPROTEINEMIA TYPE II; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; PHASE 1 CLINICAL TRIAL; PROTHROMBIN TIME; YOUNG ADULT;

ADOLESCENT; ADULT; DRUG INTERACTIONS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; HYPERLIPOPROTEINEMIA TYPE II; INTERNATIONAL NORMALIZED RATIO; MALE; MIDDLE AGED; OLIGODEOXYRIBONUCLEOTIDES, ANTISENSE; OLIGONUCLEOTIDES; PARTIAL THROMBOPLASTIN TIME; PROTHROMBIN TIME; WARFARIN; YOUNG ADULT;

EID: 84906061916     PISSN: 01602446     EISSN: 15334023     Source Type: Journal    
DOI: 10.1097/FJC.0000000000000101     Document Type: Article

References (28)

1. ALLHAT-LLT: The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT-LLT). JAMA. 2002;288:2998-3007.
2. Goldstein JL, Hobbs HH, Brown MS. Familial hypercholesterolemia. In: Scriver CR, Beaudet AL, Sly WS, Valle D (Eds). The Metabolic & Molecular Bases of Inherited Diseases. Vol 2. 8th ed. New York, NY: McGraw-Hill; 2001:2863-2913. part 12, chapter 120.
3. Genyzme and Isis Pharmaceuticals Press release. Genzyme and Isis announce FDA approval of KYNAMRO™ (mipomersen sodium) injection for the treatment of homozygous familial hypercholesterolemia. Available at: http://en.sanofi.com/ Images/31810-20130129-KYNAMRO-FDA-APPROVAL-en. pdf. Accessed July 17, 2013.
4. Crooke R, Baker BF, Wedel MK. Cardiovascular therapeutic applications. In: Crooke ST, ed. Antisense Drug Technology: Principles, Strategies and Applications. Boca Raton, FL: Taylor & Francis Group; 2007:601-639.
5. Toth PP. Antisense therapy and emerging applications for the management of dyslipidemia. J Clin Lipidol. 2011;5:441-449.
6. Kastelein JJ, Wedel MK, Baker BF, et al. Potent reduction of apolipoprotein B and low-density lipoprotein cholesterol by short-term administration of an antisense inhibitor of apolipoprotein. Circulation. 2006; 114:1729-1735. (Pubitemid 44607121)
7. Yu RZ, Kim TW, Hong A, et al. Cross-species pharmacokinetic comparison from mouse to man of a second-generation antisense oligonucleotide, ISIS 301012, targeting human apolipoprotein B-100. Drug Metab Dispos. 2007;35:460-468. (Pubitemid 46333910)
8. Yu RZ, Lemonidis KM, Graham MJ, et al. Cross-species comparison of in vivo PK/PD relationships for second-generation antisense oligonucleotides targeting apolipoprotein B-100. Biochem Pharmacol. 2009;77:910-919.
9. Yu RZ, Geary RS, Flaim JD, et al. Lack of pharmacokinetic interaction of mipomersen sodium (ISIS 301012), a 20-O-methoxyethyl modified antisense oligonucleotide targeting apolipoprotein B-100 messenger RNA, with simvastatin and ezetimibe. Clin Pharmacokinet. 2009;48:39-50.
10. Yu RZ, Grundy JS, Geary RS. Clinical pharmacokinetics of second generation antisense oligonucleotides. Expert Opin Drug Metab Toxicol. 2013;9:169-182.
11. Baek MS, Yu RZ, Gaus H, et al. In vitro metabolic stabilities and metabolism of 20-O-(methoxyethyl) partially modified phosphorothioate antisense oligonucleotides in preincubated rat or human whole liver homogenates. Oligonucleotides. 2010;20:309-316.
12. Wójcik M, Cieslak M, Stec WJ, et al. Nucleotide pyrophosphatase/phosphodiesterase 1 is responsible for degradation of antisense phosphorothioate oligonucleotides. Oligonucleotides. 2007;17:134-145. (Pubitemid 46651435)
13. Henry SP, Kim TW, Kramer-Stickland K, et al. Toxicologic properties of 20-o-methoxyethyl chimeric antisense inhibitors in animals and man. In: Crooke ST, ed. Antisense Drug Technology: Principles, Strategies and Applications. Boca Raton, FL: Taylor & Francis Group; 2007:327-363.
14. Kwoh TJ. An overview of the clinical safety experience of first-and second-generation antisense oligonucleotides. In: Crooke ST, ed. Antisense Drug Technology: Principles, Strategies and Applications. Boca Raton, FL: Taylor & Francis Group; 2007:365-399.
15. Highlights of prescribing information for COUMADIN. Available at: http://packageinserts.bms.com/pi/pi-coumadin.pdf. Accessed July 17, 2013.
16. García-Martín E, Martínez C, Ladero JM, et al. Interethnic and intraethnic variability of CYP2C8 and CYP2C9 polymorphisms in healthy individuals. Mol Diagn Ther. 2006;10:29-40.
17. Rosemary J, Adithan C. The pharmacogenetics of CYP2C9 and CYP2C19: Ethnic variation and clinical significance. Curr Clin Pharmacol. 2007;2:93-109. (Pubitemid 46729082)
18. Ansell J, Hirsh J, Hylek E, et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(suppl): 160S-198S. (Pubitemid 351892967)
19. Kaminsky LS, Zhang ZY. Human P450 metabolism of warfarin. Pharmacol Ther. 1997;73:67-74. (Pubitemid 26425815)
20. Rettie AE, Wienkers LC, Gonzalez FJ, et al. Impaired (S)-warfarin metabolism catalysed by the R144C allelic variant of CYP2C9. Pharmacogenetics. 1994;4:39-42. (Pubitemid 24106122)
21. Priskorn M, Sidhu JS, Larsen F, et al. Investigation of multiple dose citalopram on the pharmacokinetics and pharmacodynamics of racemic warfarin. Br J Clin Pharmacol. 1997;44:199-202. (Pubitemid 27327078)
22. Yates RA, Wong J, Seiberling M, et al. The effect of anastrozole on the single-dose pharmacokinetics and anticoagulant activity of warfarin in healthy volunteers. Br J Clin Pharmacol. 2001;51:429-435. (Pubitemid 32852980)
23. Jiang X, Williams KM, Liauw WS, et al. Effect of St John's wort and ginseng on the pharmacokinetics and pharmacodynamics of warfarin in healthy subjects. Br J Clin Pharmacol. 2004;57:592-599. (Pubitemid 38582179)
24. Dieterle W, Corynen S, Mann J. Effect of the oral renin inhibitor aliskiren on the pharmacokinetics and pharmacodynamics of a single dose of warfarin in healthy subjects. Br J Clin Pharmacol. 2004;58:433-436. (Pubitemid 39312468)
25. Malhotra B, Alvey C, Gong J, et al. Effects of fesoterodine on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. Br J Clin Pharmacol. 2011;72:257-262.
26. Macha S, Rose P, Mattheus M, et al. Lack of drug-drug interaction between empagliflozin, a sodium glucose cotransporter 2 inhibitor, and warfarin in healthy volunteers. Diabetes Obes Metab. 2013;15:316-323.
27. Gong IY, Schwarz UI, Crown N, et al. Clinical and genetic determinants of warfarin pharmacokinetics and pharmacodynamics during treatment initiation. PLoS One. 2011;6:e27808.
28. Garcia D, Regan S, Crowther M, et al. Warfarin maintenance dosing patterns in clinical practice: Implications for safer anticoagulation in the elderly population. Chest. 2005;127:2049-2056.