Pharmacokinetic interaction between rosuvastatin and olmesartan: A randomized, open-label, 3-period, multiple-dose crossover study in healthy Korean male subjects

Clinical Therapeutics

Volumn 36, Issue 8, 2014, Pages 1159-1170

  Roh, Hyerang ^a,b   Son, Hankil ^a,b   Lee, Donghwan ^a,b   Chang, Heechul ^c   Yun, Chohee ^c   Park, Kyungsoo ^a,b  

^a Yonsei University College of Medicine   (South Korea)

^b Yonsei University   (South Korea)

^c Daewoong Pharmaceutical Co Ltd   (South Korea)

Author keywords

drug drug interaction; olmesartan; pharmacokinetics; rosuvastatin

Indexed keywords

DRUG METABOLITE; N DESMETHYL ROSUVASTATIN; OLMESARTAN; ROSUVASTATIN; UNCLASSIFIED DRUG; ANTIHYPERTENSIVE AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMIDAZOLE DERIVATIVE; TETRAZOLE DERIVATIVE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLEPHAROCONJUNCTIVITIS; CONJUNCTIVA DISEASE; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSLIPIDEMIA; ELIMINATION RATE CONSTANT; FEVER; HEADACHE; HUMAN; HYPERTENSION; LABORATORY TEST; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MYALGIA; NORMAL HUMAN; NOSE OBSTRUCTION; PHYSICAL EXAMINATION; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; SINUS BRADYCARDIA; STEADY STATE; ADVERSE EFFECTS; ASIAN CONTINENTAL ANCESTRY GROUP; COMBINATION DRUG THERAPY; DRUG INTERACTION; MIDDLE AGED; ORAL DRUG ADMINISTRATION; SOUTH KOREA; YOUNG ADULT;

ADMINISTRATION, ORAL; ADULT; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; CROSS-OVER STUDIES; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; HEALTHY VOLUNTEERS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; IMIDAZOLES; MALE; MIDDLE AGED; REPUBLIC OF KOREA; ROSUVASTATIN CALCIUM; TETRAZOLES; YOUNG ADULT;

EID: 84906936953     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2014.06.022     Document Type: Article

References (31)

1. H. Lithell Hypertension and hyperlipidemia. A review Am J Hypertens 6 11 Pt 2 1993 303S 308S
2. C.M. White A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin J Clin Pharmacol 42 2002 963 970
3. P.H. Jones, M.H. Davidson, E.A. Stein for the STELLAR Study Group Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial) Am J Cardiol 92 2003 152 160
4. M.S. Kostapanos, H.J. Milionis, and T.D. Filippatos et al. A 12-week, prospective, open-label analysis of the effect of rosuvastatin on triglyceride-rich lipoprotein metabolism in patients with primary dyslipidemia Clin Ther 29 2007 1403 1414
5. P.H. Jones, D.B. Hunninghake, and K.C. Ferdinand et al. Effects of rosuvastatin versus atorvastatin, simvastatin, and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR trial Clin Ther 26 2004 1388 1399
6. C.V. Rizos, H.J. Milionis, and M.S. Kostapanos et al. Effects of rosuvastatin combined with olmesartan, irbesartan, or telmisartan on indices of glucose metabolism in Greek adults with impaired fasting glucose, hypertension, and mixed hyperlipidemia: a 24-week, randomized, open-label, prospective study Clin Ther 32 2010 492 505
7. M.S. Kostapanos, H.J. Milionis, and A. Agouridis et al. Rosuvastatin treatment is associated with an increase in insulin resistance in hyperlipidemic patients with impaired fasting glucose Int J Clin Pract 63 2009 1308 1313
8. Crestor Tablets. Accessdata FDA. http://www.accessdata.fda.gov/ drugsatfda-docs/label/2005/21366slr005lbl.pdf. Accessed June 20, 2013.
9. P. Manoria Olmesartan medoxomil: a clinical review Indian Heart J 58 2006 282 286
10. L.J. Scott, and P.L. McCormack Olmesartan medoxomil: a review of its use in the management of hypertension Drugs 68 2008 1239 1272
11. D.E. Mire, T.N. Silfani, and M.K. Pugsley A review of the structural and functional features of olmesartan medoxomil, an angiotensin receptor blocker J Cardiovasc Pharmacol 46 2005 585 593
12. M.I. El-Gamal, H.S. Anbar, and H.J. Chung et al. Discovery of olmesartan hexetil: a new potential prodrug of olmesartan Bioorg Med Chem Lett 23 2013 1347 1350
13. T.1 Ishizuka, Y. Yoshigae, N. Murayama, and T. Izumi Different hydrolases involved in bioactivation of prodrug-type angiotensin receptor blockers: carboxymethylenebutenolidase and carboxylesterase 1 Drug Metab Dispos 41 2013 1888 1895
14. T. Ishizuka, I. Fujimori, and A. Nishida et al. Paraoxonase 1 as a major bioactivating hydrolase for olmesartan medoxomil in human blood circulation: molecular identification and contribution to plasma metabolism Drug Metab Dispos 40 2012 374 380
15. Benicar (olmesartan medoxomil) tablet label. Accessdata FDA. http://www.accessdata.fda.gov/drugsatfda-docs/label/2012/021286s023lbl.pdf. Accessed June 20, 2013.
16. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, 2008. http://www.wma.net/en/30publications/10policies/ b3/. Accessed February 25, 2013.
17. Ministry of Food and Drug Safety (MFDS). Korea Good Clinical Practice (KGCP) guidelines [in Korean]. http://drugsafe.or.kr/iwt/ds/ko/bbs/EgovBbs.do? bbsId=BBSMSTR-000000000041&nttId=267. Accessed December 8, 2013.
18. Ministry of Food and Drug Safety (MFDS)/ Guidance for drug interaction studies and labeling. Ver-1.4, 2011 [in Korean]. http://www.mfds.go.kr/index.do? mid=1161&searchkey=title%3Acontents&searchword= %BB%F3%C8%A3%C0%DB%BF%EB&x=31&y=13. Accessed December 8, 2013.
19. S.C. Chow, and J.P. Liu Design and Analysis of Bioavailability and Bioequivalence Studies 3rd ed 2008 CRC Press, Taylor & Francis Group Boca Raton, FL 307 312
20. National Institute of Toxicological Research (NITR). Guideline on Food-Effect Bioavailability and Fed Bioequivalence Studies [in Korean]. http://www.mfds.go.kr/index.do?mid=695&seq=714&cmd=v. Accessed December 8, 2013.
21. X.N. Li et al. Pharmacokinetics of rosuvastatin in healthy Chinese volunteers living in China: a randomized, open-label, ascending single- and multiple-dose study Clin Ther 32 2010 575 587
22. Pharmacokinetics and safety of olmesartan medoxomil in combination with either amlodipine or atenolol compared to respective monotherapies in healthy subjects Fund Clin Pharmacol 23 2009 767 774
23. C.K. Hull, P.D. Martin, M.J. Warwick, and E. Thomas Quantification of the N-desmethyl metabolite of rosuvastatin in human plasma by automated SPE followed by HPLC with tandem MS detection J Pharm Biomed Anal 35 2004 609 614
24. C.K. Hull, A.D. Penman, C.K. Smith, and P.D. Martin Quantification of rosuvastatin in human plasma by automated solid-phase extraction using tandem mass spectrometric detection J Chromatogr B Analyt Technol Biomed Life Sci 772 2002 219 228
25. D. Liu, P. Hu, and N. Matsushima et al. Quantitative determination of olmesartan in human plasma and urine by liquid chromatography coupled to tandem mass spectrometry J Chromatogr B Analyt Technol Biomed Life Sci 856 2007 190 197
26. US Food and Drug Administration Center for Drug Evaluation and Research, Guidance for Industry: Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm292362.pdf. Accessed April 27, 2014.
27. H. Son, H. Roh, and D. Lee et al. Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects Clin Ther 35 2013 915 922
28. Ministry of Food and Drug Safety (MFDS). Guidance for Bioequivalence Studies [in Korean]. http://www.mfds.go.kr/index.do?mid=1161&searchkey= title%3Acontents&searchword= %BB%FD%B9%B0%C7%D0%C0%FB%B5%BF%B5%EE%BC%BA%BD%C3%C7%E8%B1%E2%C1%D8&x= 17&y=7. Accessed April 27, 2014.
29. S. Kitamura, K. Maeda, Y. Wang, and Y. Sugiyama Involvement of multiple transporters in the hepatobiliary transport of rosuvastatin Drug Metab Dispos 36 2008 2014 2023
30. A. Yamada, K. Maeda, and E. Kamiyama et al. Multiple human isoforms of drug transporters contribute to the hepatic and renal transport of olmesartan, a selective antagonist of the angiotensin II AT1-receptor Drug Metab Dispos 35 2007 2166 2176
31. J. Weiss, A. Sauer, and N. Divac et al. Interaction of angiotensin receptor type 1 blockers with ATP-binding cassette transporters Biopharm Drug Dispos 31 2010 150 161