Pharmacokinetics of Rosuvastatin: A Systematic Review of Randomised Controlled Trials in Healthy Adults.
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
accepted:
16
12
2020
pubmed:
12
1
2021
medline:
1
10
2021
entrez:
11
1
2021
Statut:
ppublish
Résumé
Rosuvastatin is a lipid-lowering drug that works by inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase, the rate-limiting enzyme responsible for producing cholesterol in humans. The pharmacokinetic data of rosuvastatin are considerably variable across studies. To review the pharmacokinetics of rosuvastatin from randomised controlled trials (RCTs) in healthy adults. A review of the pharmacokinetics of rosuvastatin was performed using systematic search strategies. The Sheiner method was used to summarise the pharmacokinetics of the drug. Randomised controlled studies (n = 70) involving healthy subjects (n = 2355) that examined the pharmacokinetics of rosuvastatin following single and multiple doses were included in the review. Rosuvastatin is given once daily in the dose range of 5-80 mg, with 40 mg being the maximum approved daily dose. Rosuvastatin achieves maximum plasma concentration at a median of 5 h (range: 0.5-6 h) under fasting conditions following single and multiple doses. Following single doses, rosuvastatin has a mean absolute oral availability of 20%, an overall mean total clearance of 28.3 L/h and an average terminal elimination half-life of approximately 20 h. The overall mean total clearance of the drug in Caucasian subjects was 1.7-fold higher than that in healthy Chinese subjects. The systemic exposure of rosuvastatin is characterised by a large coefficient of variation (48%.) There is a small accumulation with repeated dosing. The interaction of rosuvastatin with darunavir/ritonavir was considered statistically and clinically relevant. Interactions of rosuvastatin single doses with erythromycin, fluconazole, itraconazole and antacid were statistically significant. There is considerable variation in the pharmacokinetics of rosuvastatin between races. The clinical relevance of the statistically significant drug interactions is yet to be investigated following repeated co-administration for at least 15 days, consistent with a half-life of low-density lipoprotein of 3 days.
Sections du résumé
BACKGROUND
Rosuvastatin is a lipid-lowering drug that works by inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase, the rate-limiting enzyme responsible for producing cholesterol in humans. The pharmacokinetic data of rosuvastatin are considerably variable across studies.
OBJECTIVE
To review the pharmacokinetics of rosuvastatin from randomised controlled trials (RCTs) in healthy adults.
METHODS
A review of the pharmacokinetics of rosuvastatin was performed using systematic search strategies. The Sheiner method was used to summarise the pharmacokinetics of the drug.
RESULTS
Randomised controlled studies (n = 70) involving healthy subjects (n = 2355) that examined the pharmacokinetics of rosuvastatin following single and multiple doses were included in the review. Rosuvastatin is given once daily in the dose range of 5-80 mg, with 40 mg being the maximum approved daily dose. Rosuvastatin achieves maximum plasma concentration at a median of 5 h (range: 0.5-6 h) under fasting conditions following single and multiple doses. Following single doses, rosuvastatin has a mean absolute oral availability of 20%, an overall mean total clearance of 28.3 L/h and an average terminal elimination half-life of approximately 20 h. The overall mean total clearance of the drug in Caucasian subjects was 1.7-fold higher than that in healthy Chinese subjects. The systemic exposure of rosuvastatin is characterised by a large coefficient of variation (48%.) There is a small accumulation with repeated dosing. The interaction of rosuvastatin with darunavir/ritonavir was considered statistically and clinically relevant. Interactions of rosuvastatin single doses with erythromycin, fluconazole, itraconazole and antacid were statistically significant.
DISCUSSION AND CONCLUSIONS
There is considerable variation in the pharmacokinetics of rosuvastatin between races. The clinical relevance of the statistically significant drug interactions is yet to be investigated following repeated co-administration for at least 15 days, consistent with a half-life of low-density lipoprotein of 3 days.
Identifiants
pubmed: 33428168
doi: 10.1007/s40262-020-00978-9
pii: 10.1007/s40262-020-00978-9
doi:
Substances chimiques
Hydroxymethylglutaryl-CoA Reductase Inhibitors
0
Rosuvastatin Calcium
83MVU38M7Q
Types de publication
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
165-175Références
White CM. A review of the pharmacologic and pharmacokinetic aspects of rosuvastatin. J Clin Pharmacol. 2002;42(9):963–70.
pubmed: 12211221
Schachter M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam Clin Pharmacol. 2005;19(1):117–25.
pubmed: 15660968
Adams SP, Sekhon SS, Wright JM. Lipid-lowering efficacy of rosuvastatin. Cochrane Database Syst Rev. 2014;11:254.
Saku K, Zhang B, Noda K, Investigators PT. Randomized head-to-head comparison of pitavastatin, atorvastatin, and rosuvastatin for safety and efficacy (quantity and quality of LDL): the PATROL trial. Circ J. 2011;75(6):1493–505.
pubmed: 21498906
World Health Organization. Drug information Vol. 19, No. 2. 2005. Available from: http://apps.who.int/medicinedocs/en/d/Js7917e/2.13.html . [Accessed 7 Jul 2020].
McTaggart F. Comparative pharmacology of rosuvastatin. Atheroscler Suppl. 2003;4(1):9–14.
pubmed: 12714032
Martin PD, Warwick MJ, Dane AL, Hill SJ, Giles PB, Phillips PJ, et al. Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin Ther. 2003;25(11):2822–35.
pubmed: 14693307
Li XN, Xu HR, Chen WL, Chu NN, Zhu JR. Pharmacokinetics of rosuvastatin in healthy Chinese volunteers living in China: a randomized, open-label, ascending single- and multiple-dose study. Clin Ther. 2010;32(3):575–87.
pubmed: 20399994
Moon SJ, Jeon J-Y, Jang K, Yu K-S, Lim Y, Kim M-G. Pharmacokinetic interactions between telmisartan/amlodipine and rosuvastatin after multiple oral administrations in healthy Korean male subjects. Drug Des Devel Ther. 2019;13:2533.
pubmed: 31440035
pmcid: 6667348
Stopfer P, Giessmann T, Hohl K, Sharma A, Ishiguro N, Taub ME, et al. Effects of metformin and furosemide on rosuvastatin pharmacokinetics in healthy volunteers: implications for their use as probe drugs in a transporter cocktail. Eur J Drug Metab Pharmacokinet. 2018;43(1):69–80.
pubmed: 28685495
Benet LZ, Wu HF. Understanding the potential interethnic difference in rosuvastatin pharmacokinetics. J Pharm Sci. 2017;106(9):2231–3.
pubmed: 28502797
Soko N, Dandara C, Ramesar R, Kadzirange G, Masimirembwa C. Pharmacokinetics of rosuvastatin in 30 healthy Zimbabwean individuals of African ancestry. Br J Clin Pharmacol. 2016;82(1):326–8.
pubmed: 26910794
pmcid: 4917814
Huguet J, Lu J, Gaudette F, Chiasson J-L, Hamet P, Michaud V, et al. No effects of pantoprazole on the pharmacokinetics of rosuvastatin in healthy subjects. Eur J Clin Pharmacol. 2016;72(8):925–31.
pubmed: 27146814
He YJ, Zhang W, Tu JH, Kirchheiner J, Chen Y, Guo D, et al. Hepatic nuclear factor 1alpha inhibitor ursodeoxycholic acid influences pharmacokinetics of the organic anion transporting polypeptide 1B1 substrate rosuvastatin and bilirubin. Drug Metab Dispos. 2008;36(8):1453–6.
pubmed: 18443034
Martin PD, Warwick MJ, Dane AL, Brindley C, Short T. Absolute oral bioavailability of rosuvastatin in healthy white adult male volunteers. Clin Ther. 2003;25(10):2553–63.
pubmed: 14667956
Sheiner LB, Benet LZ, Pagliaro LA. A standard approach to compiling clinical pharmacokinetic data. J Pharmacokinet Biopharm. 1981;9(1):59–127.
pubmed: 7014827
Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, eds., Cochrane handbook for systematic reviews ofinterventions. John Wiley & Sons; 2019.
Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Comprehensive meta-analysis version 3 [computer software]. Englewood: Biostat; 2016.
Guideline on the investigation of bioequivalence. Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA) 2010 available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf . Accessed 5 Jan 2020.
Martin PD, Warwick MJ, Dane AL, Cantarini MV. A double-blind, randomized, incomplete crossover trial to assess the dose proportionality of rosuvastatin in healthy volunteers. Clin Ther. 2003;25(8):2215–24.
pubmed: 14512129
Li Y, Jiang X, Lan K, Zhang R, Li X, Jiang Q. Pharmacokinetic properties of rosuvastatin after single-dose, oral administration in Chinese volunteers: a randomized, open-label, three-way crossover study. Clin Ther. 2007;29(10):2194–203.
pubmed: 18042475
Gosai P, Liu J, Doyle RT, Johnson J, Carter R, Sica D, et al. Effect of omega-3-acid ethyl esters on the steady-state plasma pharmacokinetics of rosuvastatin in healthy adults. Expert Opin Pharmacol. 2008;9(17):2947–53.
Rovasyn 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). 2014. https://mri.cts-mrp.eu/human/downloads/DK_H_2232_004_PAR.pdf . Accessed 20 May 2019.
Prueksaritanont T, Chu X, Evers R, Klopfer SO, Caro L, Kothare PA, et al. Pitavastatin is a more sensitive and selective organic anion-transporting polypeptide 1B clinical probe than rosuvastatin. Br J Clin Pharmacol. 2014;78(3):587–98.
pubmed: 24617605
pmcid: 4243909
Rosuvastatine Resochem 5 mg, 10 mg, 20 mg and 40 mg, film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3059/001-004/DC. 2015. https://www.geneesmiddeleninformatiebank.nl/Pars/h114550.pdf . Accessed 20 May 2019.
Rosuvastatine Torrent 5 mg, 10 mg, 20 mg and 40 mg, film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). 2014. https://www.geneesmiddeleninformatiebank.nl/Pars/h113086.pdf . Accessed 20 May 2019.
Rosuvastatine Accord 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3255/001-004/DC. 2016. https://mri.cts-mrp.eu/Human/Downloads/NL_H_3255_001_PAR.pdf . Accessed 20 May 2019.
Rosuvastatine Hetero 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3517/001-004/DC. 2016. https://www.geneesmiddeleninformatiebank.nl/Pars/h117528.pdf . Accessed 20 May 2019.
Hetero (rosuvastatin). Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: CZ/H/0636/001-004/DC. 2017. https://www.geneesmiddeleninformatiebank.nl/Pars/h117528.pdf . Accessed 20 May 2019.
Rosuvastatin Galenicum 5mg, 10mg, 20mg and 40mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: MT/H/0202/001-004/DC. 2017. https://mri.cts-mrp.eu/human/downloads/MT_H_0202_002_PAR.pdf . Accessed 29 May 2019.
Rosuvastatine Genericon 10 mg, 20 mg and 40 mg, film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3584/001-003/DC. 2017. https://mri.cts-mrp.eu/human/downloads/NL_H_3584_001_PAR.pdf . Accessed 29 May 2019.
Lyklarzu rosuvastatin calcium. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: DK/H/2553/01-04/DC. 2017. https://mri.cts-mrp.eu/Human/Downloads/DK_H_2553_001_PAR.pdf . Accessed 29 May 2019.
Rosuvastatine Bristol 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3698/001-004/DC. 2017. https://www.geneesmiddeleninformatiebank.nl/Pars/h119055.pdf . Accessed 29 May 2019.
Rosuvastatine SUN 5 mg, 10 mg, 20 mg and 40 mg, film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3557/001-004/DC. 2017. https://www.geneesmiddeleninformatiebank.nl/Pars/h118014.pdf . Accessed 29 May 2019.
Rosuvastatine Momaja 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3366/001-004/DC. 2017. https://mri.cts-mrp.eu/Human/Downloads/NL_H_3366_001_PAR.pdf . Accessed 29 Jun 2019.
Rosuvastatin Jenson 5-40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: UK/H/5702/002/DC. 2018. https://myhealthbox.eu/hy/view/3757991/bf72fff70a49d75c8748eb2414757742/leaflet . Accessed 29 Jun 2019.
Zaid AN, Al Ramahi R, Cortesi R, Mousa A, Jaradat N, Ghazal N, et al. Investigation of the bioequivalence of rosuvastatin 20 mg tablets after a single oral administration in Mediterranean Arabs using a validated LC-MS/MS method. Sci Pharm. 2016;84(3):536–46.
pubmed: 28117319
pmcid: 5064244
Rosuvastatin Sigillata. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: DK/H/2681/001-003/DC. 2018. https://mri.cts-mrp.eu/human/downloads/DK_H_2681_001_PAR.pdf . Accessed 29 Jun 2019.
Harahap Y, Prasaja B, Azmi F, Lusthom W, Sinandang T, Felicia V, et al. Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects. Int J Clin Pharmacol Ther. 2016;54(3):212–6.
pubmed: 26073355
Martin PD, Schneck DW, Dane AL, Warwick MJ. The effect of a combination antacid preparation containing aluminium hydroxide and magnesium hydroxide on rosuvastatin pharmacokinetics. Curr Med Res Opin. 2008;24(4):1231–5.
pubmed: 18355422
Cooper KJ, Martin PD, Dane AL, Warwick MJ, Raza A, Schneck DW. The effect of erythromycin on the pharmacokinetics of rosuvastatin. Eur J Clin Pharmacol. 2003;59(1):51–6.
pubmed: 12682802
Cooper KJ, Martin PD, Dane AL, Warwick MJ, Schneck DW, Cantarini MV. The effect of fluconazole on the pharmacokinetics of rosuvastatin. Eur J Clin Pharmacol. 2002;58(8):527–31.
pubmed: 12451430
Cooper KJ, Martin PD, Dane AL, Warwick MJ, Schneck DW, Cantarini MV. Effect of itraconazole on the pharmacokinetics of rosuvastatin. Clin Pharmacol Ther. 2003;73(4):322–9.
pubmed: 12709722
Deng JW, Shon JH, Shin HJ, Park SJ, Yeo CW, Zhou HH, et al. Effect of silymarin supplement on the pharmacokinetics of rosuvastatin. Pharm Res. 2008;25(8):1807–14.
pubmed: 18236139
Zhang W, Deng S, Chen X-P, Zhou G, Xie H-T, He F-Y, et al. Pharmacokinetics of rosuvastatin when coadministered with rifampicin in healthy males: a randomized, single-blind, placebo-controlled, crossover study. Clin Ther. 2008;30(7):1283–9.
pubmed: 18691987
Lee J, Rhee SJ, Lee S, Yu KS. Evaluation of drug interactions between fimasartan and rosuvastatin after single and multiple doses in healthy Caucasians. Drug Des Devel Ther. 2018;12:787–94.
pubmed: 29670335
pmcid: 5896677
Caltabiano S, Mahar KM, Lister K, Tenero D, Ravindranath R, Cizman B, et al. The drug interaction potential of daprodustat when coadministered with pioglitazone, rosuvastatin, or trimethoprim in healthy subjects. Pharmacol Res Perspect. 2018;6(2):e00327.
pubmed: 29545948
pmcid: 5843756
Schneck DW, Birmingham BK, Zalikowski JA, Mitchell PD, Wang Y, Martin PD, et al. The effect of gemfibrozil on the pharmacokinetics of rosuvastatin. Clin Pharmacol Ther. 2004;75(5):455–63.
pubmed: 15116058
Shah Y, Iqbal Z, Ahmad L, Khuda F, Khan A, Khan A, et al. Effect of omeprazole on the pharmacokinetics of rosuvastatin in healthy male volunteers. Am J Ther. 2016;23(6):e1514–23.
pubmed: 25719441
Cooper KJ, Martin PD, Dane AL, Warwick MJ, Raza A, Schneck DW. Lack of effect of ketoconazole on the pharmacokinetics of rosuvastatin in healthy subjects. Br J Clin Pharmacol. 2003;55(1):94–9.
pubmed: 12534645
pmcid: 1884190
Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, et al. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015;31(2):229–41.
pubmed: 25350224
Foley-Comer AJ, Young AM, Russell-Yarde F, Jordan P. Aleglitazar, a balanced PPARalpha/gamma agonist, has no clinically relevant pharmacokinetic interaction with high-dose atorvastatin or rosuvastatin. Expert Opin Investig Drugs. 2011;20(1):3–12.
pubmed: 21114416
Jung JA, Lee SY, Kim JR, Ko JW, Jang SB, Nam SY, et al. A pharmacokinetic and pharmacodynamic drug interaction between rosuvastatin and valsartan in healthy subjects. Drug Des Devel Ther. 2015;9:745–52.
pubmed: 25767372
pmcid: 4354399
Kim CO, Oh ES, Kim H, Park MS. Pharmacokinetic interactions between glimepiride and rosuvastatin in healthy Korean subjects: does the SLCO1B1 or CYP2C9 genetic polymorphism affect these drug interactions? Drug Des Devel Ther. 2017;11:503–12.
pubmed: 28260863
pmcid: 5330189
Kosoglou T, Statkevich P, Yang B, Suresh R, Zhu Y, Boutros T, et al. Pharmacodynamic interaction between ezetimibe and rosuvastatin. Curr Med Res Opin. 2004;20(8):1185–95.
pubmed: 15324521
Lee D, Roh H, Son H, Jang SB, Lee S, Nam SY, et al. Pharmacokinetic interaction between rosuvastatin and metformin in healthy Korean male volunteers: a randomized, open-label, 3-period, crossover, multiple-dose study. Clin Ther. 2014;36(8):1171–81.
pubmed: 24976448
Martin PD, Dane AL, Schneck DW, Warwick MJ. An open-label, randomized, three-way crossover trial of the effects of coadministration of rosuvastatin and fenofibrate on the pharmacokinetic properties of rosuvastatin and fenofibric acid in healthy male volunteers. Clin Ther. 2003;25(2):459–71.
pubmed: 12749507
Son HRH, Lee D, Chang H, Kim J, Yun C, 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. 2013;35(7):915–22.
pubmed: 23810276
Samineni D, Desai PB, Sallans L, Fichtenbaum CJ. Steady-state pharmacokinetic interactions of darunavir/ritonavir with lipid-lowering agent rosuvastatin. J Clin Pharmacol. 2012;52(6):922–31.
pubmed: 21712498
Simonson SG, Martin PD, Mitchell PD, Lasseter K, Gibson G, Schneck DW. Effect of rosuvastatin on warfarin pharmacodynamics and pharmacokinetics. J Clin Pharmacol. 2005;45(8):927–34.
pubmed: 16027403
Son M, Guk J, Kim Y, Chae DW, Heo Y-A, Soh D, et al. Pharmacokinetic interaction between rosuvastatin, telmisartan, and amlodipine in healthy male Korean subjects: a randomized, open-label, multiple-dose, 2-period crossover study. Clin Ther. 2016;38(8):1845–57.
pubmed: 27422590
Son M, Kim Y, Lee D, Roh H, Son H, Guk J, et al. Pharmacokinetic interaction between rosuvastatin and telmisartan in healthy Korean male volunteers: a randomized, open-label, two-period, crossover, multiple-dose study. Clin Ther. 2014;36(8):1147–58.
pubmed: 24998012
Zhu T, Awni WM, Hosmane B, Kelly MT, Sleep DJ, Stolzenbach JC, et al. ABT-335, the choline salt of fenofibric acid, does not have a clinically significant pharmacokinetic interaction with rosuvastatin in humans. J Clin Pharmacol. 2009;49(1):63–71.
pubmed: 18952910
Seong SJ, Ohk B, Kang WY, Gwon MR, Kim BK, Cho S, et al. Pharmacokinetic drug interactions between amlodipine, valsartan, and rosuvastatin in healthy volunteers. Adv Ther. 2019;36(7):1642–56.
pubmed: 31119689
Roh H, Son H, Lee D, Chang H, Yun C, Park K. Pharmacokinetic interaction between rosuvastatin and olmesartan: a randomized, open-label, 3-period, multiple-dose crossover study in healthy Korean male subjects. Clin Ther. 2014;36(8):1159–70.
pubmed: 25017182
Birmingham BK, Bujac SR, Elsby R, Azumaya CT, Zalikowski J, Chen Y, et al. Rosuvastatin pharmacokinetics and pharmacogenetics in Caucasian and Asian subjects residing in the United States. Eur J Clin Pharmacol. 2015;71(3):329–40.
pubmed: 25630984
Tomlinson B, Chan P, Liu ZM. Statin responses in Chinese patients. J Atheroscler Thromb. 2018;25(2):199–202.
pubmed: 28740057
pmcid: 5827089
Naito R, Miyauchi K, Daida H. Racial differences in the cholesterol-lowering effect of statin. J Atheroscler Thromb. 2017;24(1):19–25.
pubmed: 27733728
pmcid: 5225129
DeGorter MK, Tirona RG, Schwarz UI, Choi YH, Dresser GK, Suskin N, et al. Clinical and pharmacogenetic predictors of circulating atorvastatin and rosuvastatin concentrations in routine clinical care. Circ Cardiovasc Genet. 2013;6(4):400–8.
pubmed: 23876492
pmcid: 3922121
Daniels TF, Killinger KM, Michal JJ, Wright RW Jr, Jiang Z. Lipoproteins, cholesterol homeostasis and cardiac health. Int J Biol Sci. 2009;5(5):474–88.
pubmed: 19584955
pmcid: 2706428
Tzeng TB, Schneck DW, Birmingham BK, Mitchell PD, Zhang H, Martin PD, et al. Population pharmacokinetics of rosuvastatin: implications of renal impairment, race, and dyslipidaemia. Curr Med Res Opin. 2008;24(9):2575–85.
pubmed: 18674408
Martin PD, Dane AL, Nwose OM, Schneck DW, Warwick MJ. No effect of age or gender on the pharmacokinetics of rosuvastatin: a new HMG-CoA reductase inhibitor. J Clin Pharmacol. 2002;42(10):1116–21.
pubmed: 12362926
Nazir S, Iqbal Z, Shah Y, Ahmad L, Khan A. Pharmacokinetic study of rosuvastatin in males and females. Eur J Drug Metab Pharmacokinet. 2015;40(3):313–8.
pubmed: 24920353
Davidson MH. Rosuvastatin: a highly efficacious statin for the treatment of dyslipidaemia. Expert Opin Investig Drugs. 2002;11(1):125–41.
pubmed: 12769127
Simonson SG, Raza A, Martin PD, Mitchell PD, Jarcho JA, Brown CD, et al. Rosuvastatin pharmacokinetics in heart transplant recipients administered an antirejection regimen including cyclosporine. Clin Pharmacol Ther. 2004;76(2):167–77.
pubmed: 15289793
Patel D, Bertz R, Ren S, Boulton DW, Nagard M. A systematic review of gastric acid-reducing agent-mediated drug-drug interactions with orally administered medications. Clin Pharmacokinet. 2020;59(4):447–62.
pubmed: 31788764
Ho RH, Tirona RG, Leake BF, Glaeser H, Lee W, Lemke CJ, et al. Drug and bile acid transporters in rosuvastatin hepatic uptake: function, expression, and pharmacogenetics. Gastroenterology. 2006;130(6):1793–806.
pubmed: 16697742
Thota S, Tippabhotla S, Khan S, Nakkawar M. Two-way crossover bioequivalence study of rosuvastatin tablets 5 mg in healthy, adult, asian-indian male volunteers under fasting condition. Int J Pharm Pharm Sci. 2013;5(3):289–93.
Rosuvastatin DSM Sinochem 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: NL/H/3453/001-004/DC. 2017. https://mri.ctsmrp.eu/Human/Downloads/NL_H_3453_004_PAR.pdf . Accessed 28 Jun 2019.
National Institute of Pharmacy, Directorate of GYEMSZI. Rosuvastatin-Teva film-coated tablets, rosuvastatin calcium 5, 10, 20, 40 mg. Public assessment report issued by the Heads of Medicines Agencies (HMA). Contract No.: HU/H/0218/001-004/DC. 2012. https://ogyei.gov.hu/kiseroirat/ph/ph_0000032428.pdf . Accessed 29 Jun 2019.
Astra Zeneca Canada. Crestor product monograph (14 May 2020). https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/crestor-product-monograph-en.pdf . Accessed 30 Nov 2020.
Trabelsi F, Bartůnek A, Vlavonou R, Navrátilová L, Dubé C, Tanguay M, et al. Single-dose, 2-way crossover, bioequivalence study of two rosuvastatin formulations in normal healthy subjects under fasting conditions. Int J Clin Pharmacol Ther. 2012;50(10):741–50.
pubmed: 22762855