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Review

The clinical significance of statins-macrolides interaction: comprehensive review of in vivo studies, case reports, and population studies

, &
Pages 921-936 | Published online: 23 Jul 2019

References

  • Schachter M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam Clin Pharmacol. 2005;19(1):117–125. doi:10.1111/j.1472-8206.2004.00299.x15660968
  • Stancu C, Sima A. Statins: mechanism of action and effects. J Cell Mol Med. 2001;5(4):378–387. doi:10.1111/j.1582-4934.2001.tb00172.x12067471
  • Naci H, Brugts JJ, Fleurence R, Tsoi B, Toor H, Ades AE. Comparative benefits of statins in the primary and secondary prevention of major coronary events and all-cause mortality: a network meta-analysis of placebo-controlled and active-comparator trials. Eur J Prev Cardiol. 2013;20(4):641–657. doi:10.1177/204748731348043523447425
  • Istvan ES, Deisenhofer J. Structural mechanism for statin inhibition of HMG-CoA reductase. Science (New York, NY). 2001;292(5519):1160–1164. doi:10.1126/science.1059344
  • Everett DW, Chando TJ, Didonato GC, Singhvi SM, Pan HY, Weinstein SH. Biotransformation of pravastatin sodium in humans. Drug Metab Dispos. 1991;19(4):740–748.1680649
  • Martin PD, Warwick MJ, Dane AL, et al. Metabolism, excretion, and pharmacokinetics of rosuvastatin in healthy adult male volunteers. Clin Ther. 2003;25(11):2822–2835.14693307
  • Saito Y. Pitavastatin: an overview. Atheroscler Suppl. 2011;12(3):271–276. doi:10.1016/S1567-5688(11)70886-822152281
  • Elsby R, Hilgendorf C, Fenner K. Understanding the critical disposition pathways of statins to assess drug-drug interaction risk during drug development: it’s not just about OATP1B1. Clin Pharmacol Ther. 2012;92(5):584–598. doi:10.1038/clpt.2012.16323047648
  • Henwood JM, Heel RC. Lovastatin. A preliminary review of its pharmacodynamic properties and therapeutic use in hyperlipidaemia. Drugs. 1988;36(4):429–454. doi:10.2165/00003495-198836040-000033069436
  • Igel M, Sudhop T, von Bergmann K. Metabolism and drug interactions of 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins). Eur J Clin Pharmacol. 2001;57(5):357–364.11599653
  • Beauduy CE, Winston LG. Tetracyclines, macrolides, clindamycin, chloramphenicol, streptogramins, & oxazolidinones In: Katzung BG, editor. Basic & Clinical Pharmacology, 14e. New York, NY: McGraw-Hill Education; 2017: 815–825.
  • Shi J, Montay G, Bhargava VO. Clinical pharmacokinetics of telithromycin, the first ketolide antibacterial. Clin Pharmacokinet. 2005;44(9):915–934. doi:10.2165/00003088-200544090-0000316122280
  • Zuckerman JM, Qamar F, Bono BR. Review of Macrolides (Azithromycin, Clarithromycin), Ketolids (Telithromycin) and Glycylcyclines (Tigecycline). Med Clin. 2011;95(4):761–791. doi:10.1016/j.mcna.2011.03.012
  • Parkinson A, Ogilvie BW, Buckley DB, Kazmi F, Czerwinski M, Parkinson O. Biotransformation of xenobiotics In: Casarett and Doull’s Toxicology: The Basic Science of Poisons, 8e. Curtis D. Klaassen. New York, NY: McGraw-Hill Education; 2012: 185–366.
  • Hirota T, Ieiri I. Drug-drug interactions that interfere with statin metabolism. Expert Opin Drug Metab Toxicol. 2015;11(9):1435–1447. doi:10.1517/17425255.2015.105614926058399
  • Pinto AG, Wang YH, Chalasani N, et al. Inhibition of human intestinal wall metabolism by macrolide antibiotics: effect of clarithromycin on cytochrome P450 3A4/5 activity and expression. Clin Pharmacol Ther. 2005;77(3):178–188. doi:10.1016/j.clpt.2004.10.00215735612
  • Greenblatt DJ, von Moltke LL, Harmatz JS, et al. Inhibition of triazolam clearance by macrolide antimicrobial agents: in vitro correlates and dynamic consequences. Clin Pharmacol Ther. 1998;64(3):278–285. doi:10.1016/S0009-9236(98)90176-X9757151
  • Ito K, Ogihara K, Kanamitsu S, Itoh T. Prediction of the in vivo interaction between midazolam and macrolides based on in vitro studies using human liver microsomes. Drug Metab Dispos. 2003;31(7):945–954. doi:10.1124/dmd.31.7.94512814973
  • Polasek TM, Miners JO. Quantitative prediction of macrolide drug-drug interaction potential from in vitro studies using testosterone as the human cytochrome P4503A substrate. Eur J Clin Pharmacol. 2006;62(3):203–208. doi:10.1007/s00228-005-0091-x16416302
  • Quinney SK, Malireddy SR, Vuppalanchi R, et al. Rate of onset of inhibition of gut-wall and hepatic CYP3A by clarithromycin. Eur J Clin Pharmacol. 2013;69(3):439–448. doi:10.1007/s00228-012-1339-x22777148
  • Zhou S, Yung Chan S, Cher Goh B, et al. Mechanism-based inhibition of cytochrome P450 3A4 by therapeutic drugs. Clin Pharmacokinet. 2005;44(3):279–304. doi:10.2165/00003088-200544030-0000515762770
  • Lin JH, Lu AY. Inhibition and induction of cytochrome P450 and the clinical implications. Clin Pharmacokinet. 1998;35(5):361–390. doi:10.2165/00003088-199835050-000039839089
  • Niemi M. Role of OATP transporters in the disposition of drugs. Pharmacogenomics. 2007;8(7):787–802. doi:10.2217/14622416.8.7.78718240907
  • Kameyama Y, Yamashita K, Kobayashi K, Hosokawa M, Chiba K. Functional characterization of SLCO1B1 (OATP-C) variants, SLCO1B1*5, SLCO1B1*15 and SLCO1B1*15+C1007G, by using transient expression systems of HeLa and HEK293 cells. Pharmacogenet Genomics. 2005;15(7):513–522.15970799
  • Jiang F, Choi JY, Lee JH, et al. The influences of SLCO1B1 and ABCB1 genotypes on the pharmacokinetics of simvastatin, in relation to CYP3A4 inhibition. Pharmacogenomics. 2017;18(5):459–469. doi:10.2217/pgs-2016-019928350522
  • Menochet K, Kenworthy KE, Houston JB, Galetin A. Use of mechanistic modeling to assess interindividual variability and interspecies differences in active uptake in human and rat hepatocytes. Drug Metab Dispos. 2012;40(9):1744–1756. doi:10.1124/dmd.112.04619322665271
  • Lau YY, Huang Y, Frassetto L, Benet LZ. Effect of OATP1B transporter inhibition on the pharmacokinetics of atorvastatin in healthy volunteers. Clin Pharmacol Ther. 2007;81(2):194–204. doi:10.1038/sj.clpt.610003817192770
  • Niemi M, Pasanen MK, Neuvonen PJ. SLCO1B1 polymorphism and sex affect the pharmacokinetics of pravastatin but not fluvastatin. Clin Pharmacol Ther. 2006;80(4):356–366. doi:10.1016/j.clpt.2006.06.01017015053
  • Chang JH, Zhang X, Messick K, et al. Unremarkable impact of Oatp inhibition on the liver concentration of fluvastatin, lovastatin and pitavastatin in wild-type and Oatp1a/1b knockout mouse. Xenobiotica. 2018;49:1–9.
  • Pasanen MK, Fredrikson H, Neuvonen PJ, Niemi M. Different effects of SLCO1B1 polymorphism on the pharmacokinetics of atorvastatin and rosuvastatin. Clin Pharmacol Ther. 2007;82(6):726–733. doi:10.1038/sj.clpt.610022017473846
  • Deng JW, Song IS, Shin HJ, et al. The effect of SLCO1B1*15 on the disposition of pravastatin and pitavastatin is substrate dependent: the contribution of transporting activity changes by SLCO1B1*15. Pharmacogenet Genomics. 2008;18(5):424–433. doi:10.1097/FPC.0b013e3282fb02a318408565
  • Prueksaritanont T, Chu X, Evers R, 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):587–598. doi:10.1111/bcp.1237724617605
  • Kunze A, Huwyler J, Camenisch G, Poller B. Prediction of organic anion-transporting polypeptide 1B1- and 1B3-mediated hepatic uptake of statins based on transporter protein expression and activity data. Drug Metab Dispos. 2014;42(9):1514–1521. doi:10.1124/dmd.114.05841224989890
  • Seithel A, Eberl S, Singer K, et al. The influence of macrolide antibiotics on the uptake of organic anions and drugs mediated by OATP1B1 and OATP1B3. Drug Metab Dispos. 2007;35(5):779–786. doi:10.1124/dmd.106.01440717296622
  • Hirano M, Maeda K, Shitara Y, Sugiyama Y. Drug-drug interaction between pitavastatin and various drugs via OATP1B1. Drug Metab Dispos. 2006;34(7):1229–1236. doi:10.1124/dmd.106.00929016595711
  • Keskitalo JE, Kurkinen KJ, Neuvoneni PJ, Niemi M. ABCB1 haplotypes differentially affect the pharmacokinetics of the acid and lactone forms of simvastatin and atorvastatin. Clin Pharmacol Ther. 2008;84(4):457–461. doi:10.1038/clpt.2008.2519238649
  • Hochman JH, Pudvah N, Qiu J, et al. Interactions of human P-glycoprotein with simvastatin, simvastatin acid, and atorvastatin. Pharm Res. 2004;21(9):1686–1691.15497697
  • Umeyama Y, Fujioka Y, Okuda T. Clarification of P-glycoprotein inhibition-related drug-drug interaction risks based on a literature search of the clinical information. Xenobiotica. 2014;44(12):1135–1144. doi:10.3109/00498254.2014.92895824937160
  • Holtzman CW, Wiggins BS, Spinler SA. Role of P-glycoprotein in statin drug interactions. Pharmacotherapy. 2006;26(11):1601–1607. doi:10.1592/phco.26.11.160117064205
  • Mao Q, Unadkat JD. Role of the breast cancer resistance protein (BCRP/ABCG2) in drug transport–an update. Aaps J. 2014;17(1):65–82. doi:10.1208/s12248-014-9668-625236865
  • Keskitalo JE, Zolk O, Fromm MF, Kurkinen KJ, Neuvonen PJ, Niemi M. ABCG2 polymorphism markedly affects the pharmacokinetics of atorvastatin and rosuvastatin. Clin Pharmacol Ther. 2009;86(2):197–203. doi:10.1038/clpt.2009.7919474787
  • Keskitalo JE, Pasanen MK, Neuvonen PJ, Niemi M. Different effects of the ABCG2 c.421C>A SNP on the pharmacokinetics of fluvastatin, pravastatin and simvastatin. Pharmacogenomics. 2009;10(10):1617–1624. doi:10.2217/pgs.09.8519842935
  • Watanabe T, Kusuhara H, Watanabe T, et al. Prediction of the overall renal tubular secretion and hepatic clearance of anionic drugs and a renal drug-drug interaction involving organic anion transporter 3 in humans by in vitro uptake experiments. Drug Metab Dispos. 2011;39(6):1031–1038. doi:10.1124/dmd.110.03612921383204
  • Niemi M, Arnold KA, Backman JT, et al. Association of genetic polymorphism in ABCC2 with hepatic multidrug resistance-associated protein 2 expression and pravastatin pharmacokinetics. Pharmacogenet Genomics. 2006;16(11):801–808. doi:10.1097/01.fpc.0000230422.50962.9117047488
  • Kullak-Ublick GA, Stieger B, Meier PJ. Enterohepatic bile salt transporters in normal physiology and liver disease. Gastroenterology. 2004;126(1):322–342.14699511
  • Bi YA, Qiu X, Rotter CJ, et al. Quantitative assessment of the contribution of sodium-dependent taurocholate co-transporting polypeptide (NTCP) to the hepatic uptake of rosuvastatin, pitavastatin and fluvastatin. Biopharm Drug Dispos. 2013;34(8):452–461. doi:10.1002/bdd.186123996477
  • Khan FY. Rhabdomyolysis: a review of the literature. Neth J Med. 2009;67(9):272–283.19841484
  • Jacobson TA. Comparative pharmacokinetic interaction profiles of pravastatin, simvastatin, and atorvastatin when coadministered with cytochrome P450 inhibitors. Am J Cardiol. 2004;94(9):1140–1146. doi:10.1016/j.amjcard.2004.07.08015518608
  • Kantola T, Kivisto KT, Neuvonen PJ. Erythromycin and verapamil considerably increase serum simvastatin and simvastatin acid concentrations. Clin Pharmacol Ther. 1998;64(2):177–182. doi:10.1016/S0009-9236(98)90151-59728898
  • KETEX (telithromycin) tablets [Prescribing Information-drug Interactions]. Bridgewater, NJ 08807: Sanofi-aventis U.S. LLC; 2015.
  • Kaleem Z, Khan JA, Mushtaq Z, Altaf S, Javed I. Assessment of potential interaction between simvastatin and clarithromycin in healthy adult male subjects. Pak J Pharm Sci. 2018;31(3):801–806.29716858
  • Siedlik PH, Olson SC, Yang BB, Stern RH. Erythromycin coadministration increases plasma atorvastatin concentrations. J Clin Pharmacol. 1999;39(5):501–504.10234598
  • LIPITOR (atorvastatin) tablets [prescribing information]. NY, NY 10017: Parke-Davis-Pfizer Inc; 2009.
  • Amsden GW, Kuye O, Wei GC. A study of the interaction potential of azithromycin and clarithromycin with atorvastatin in healthy volunteers. J Clin Pharmacol. 2002;42(4):444–449.11936570
  • 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):51–56. doi:10.1007/s00228-003-0573-712682802
  • LIVALO (pitavastatin) prescribing information (drug interactions); 2016 Available from: https://www.kowapharma.com/documents/LIVALO_PI_CURRENT.pdf. Accessed 512, 2018.
  • Torres PA, Helmstetter JA, Kaye AM, Kaye AD. Rhabdomyolysis: pathogenesis, diagnosis, and treatment. Ochsner J. 2015;15(1):58–69.25829882
  • Davidson MH, Clark JA, Glass LM, Kanumalla A. Statin safety: an appraisal from the adverse event reporting system. Am J Cardiol. 2006;97(8a):32c–43c. doi:10.1016/j.amjcard.2005.12.008
  • Hill FJ, McCloskey SJ, Sheerin N. From a fish tank injury to hospital haemodialysis: the serious consequences of drug interactions. BMJ Case Rep. 2015;2015:bcr2015209961. doi:10.1136/bcr-2015-209961
  • Fallah A, Deep M, Smallwood D, Hughes P. Life-threatening rhabdomyolysis following the interaction of two commonly prescribed medications. Australas Med J. 2013;6(3):112–114. doi:10.4066/AMJ.2013.161623589735
  • Azmi HM, Fahad S, Kumar VA. Lovastatin-erythromycin induced myositis: case report and possible mechanism. J Pharm Pharm. 2015;1(1):30–32. doi:10.5530/jppcm.2015.1.7
  • Grunden JW, Fisher KA. Lovastatin-induced rhabdomyolysis possibly associated with clarithromycin and azithromycin. Ann Pharmacother. 1997;31(7–8):859–863. doi:10.1177/1060028097031007109220046
  • Kahri AJ, Valkonen MM, Vuoristo MK, Pentikäinen PJ. Rhabdomyolysis associated with concomitant use of simvastatin and clarithromycin. Ann Pharmacother. 2004;38(4):719. doi:10.1345/aph.1D243
  • Spach DH, Bauwens JE, Clark CD, Burke WG. Rhabdomyolysis associated with lovastatin and erythromycin use. West J Med. 1991;154(2):213–215.2006579
  • Alreja G, Inayatullah S, Goel S, Braden G. Rhabdomyolysis caused by an unusual interaction between azithromycin and simvastatin. J Cardiovasc Dis Res. 2012;3(4):319–322. doi:10.4103/0975-3583.10272023233778
  • Wagner J, Suessmair C, Pfister HW. Rhabdomyolysis caused by co-medication with simvastatin and clarithromycin. J Neurol. 2009;256(7):1182–1183. doi:10.1007/s00415-009-5078-619252767
  • Page SR, Yee KC. Rhabdomyolysis in association with simvastatin and dosage increment in clarithromycin. Intern Med J. 2014;44(7):690–693. doi:10.1111/imj.1246425041770
  • Lee AJ, Maddix DS. Rhabdomyolysis secondary to a drug interaction between simvastatin and clarithromycin. Ann Pharmacother. 2001;35(1):26–31. doi:10.1345/aph.1017711197581
  • Molden E, Andersson KS. Simvastatin-associated rhabdomyolysis after coadministration of macrolide antibiotics in two patients. Pharmacotherapy. 2007;27(4):603–607. doi:10.1592/phco.27.4.60317381388
  • Nguyen KA, Li L, Lu D, et al. A comprehensive review and meta-analysis of risk factors for statin-induced myopathy. Eur J Clin Pharmacol. 2018;74(9):1099–1109. doi:10.1007/s00228-018-2482-929785580
  • Mendes P, Robles PG, Mathur S. Statin-induced rhabdomyolysis: a comprehensive review of case reports. Physiother Can. 2014;66(2):124–132. doi:10.3138/ptc.2012-6524799748
  • Cziraky MJ, Willey VJ, McKenney JM, et al. Statin safety: an assessment using an administrative claims database. Am J Cardiol. 2006;97(8a):61c–68c. doi:10.1016/j.amjcard.2005.12.01116377285
  • Slobodnick A, Shah B, Pillinger MH, Krasnokutsky S. Colchicine: old and new. Am J Med. 2015;128(5):461–470. doi:10.1016/j.amjmed.2014.12.01025554368
  • Davis MW, Wason S, Digiacinto JL. Colchicine-antimicrobial drug interactions: what pharmacists need to know in treating gout. Consult Pharm. 2013;28(3):176–183. doi:10.4140/TCP.n.2013.17623462027
  • Nishio S, Watanabe H, Kosuge K, Uchida S, Hayashi H, Ohashi K. Interaction between amlodipine and simvastatin in patients with hypercholesterolemia and hypertension. Hypertens Res. 2005;28(3):223–227. doi:10.1291/hypres.28.22316097365
  • Pan Y, Chothe PP, Swaan PW. Identification of novel Breast Cancer Resistance Protein (BCRP) Inhibitors by virtual screening. Mol Pharm. 2013;10(4):1236–1248. doi:10.1021/mp300547h23418667
  • Strandell J, Bate A, Hagg S, Edwards IR. Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction. Br J Clin Pharmacol. 2009;68(3):427–434. doi:10.1111/j.1365-2125.2009.03473.x19740401
  • Rowan C, Brinker AD, Nourjah P, et al. Rhabdomyolysis reports show interaction between simvastatin and CYP3A4 inhibitors. Pharmacoepidemiol Drug Saf. 2009;18(4):301–309. doi:10.1002/pds.171119206087
  • Rowan CG, Brunelli SM, Munson J, et al. Clinical importance of the drug interaction between statins and CYP3A4 inhibitors: a retrospective cohort study in the health improvement network. Pharmacoepidemiol Drug Saf. 2012;21(5):494–506. doi:10.1002/pds.319922422642
  • Patel AM, Shariff S, Bailey DG, et al. Statin toxicity from macrolide antibiotic coprescription: a population-based cohort study. Ann Intern Med. 2013;158(12):869–876. doi:10.7326/0003-4819-158-12-201306180-0000423778904
  • Li DQ, Kim R, McArthur E, et al. Risk of adverse events among older adults following co-prescription of clarithromycin and statins not metabolized by cytochrome P450 3A4. Can Med Assoc J. 2015;187(3):174–180. doi:10.1503/cmaj.14095025534598
  • Mesgarpour B, Gouya G, Herkner H, Reichardt B, Wolzt M. A population-based analysis of the risk of drug interaction between clarithromycin and statins for hospitalisation or death. Lipids Health Dis. 2015;14:131. doi:10.1186/s12944-015-0134-y26497728
  • Kolovou V, Bilianou H, Kolovou G. Safe use of statins: focus on muscle toxicity. Clin Lipidol. 2016;11(1):16–22.
  • Chang C-H, Kusama M, Ono S, Sugiyama Y, Orii T, Akazawa M. Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information. BMJ Open. 2013;3(4):e002040. doi:10.1136/bmjopen-2012-002040
  • New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury FDA Drug Safety Communication. August 6th, 2011 Available from: https://wayback.archive-it.org/7993/20170112031805/http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm. Accessed December 11, 2018.
  • ZOCOR (simvastatin) tablets [prescribing information]. Cramlington, Northumberland, UK NE23 3JU: Merck Sharp & Dohme Ltd; 2010.
  • Lovastatin - FDA prescribing information, side effects and uses. Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA; 2018 Available from: https://www.drugs.com/pro/lovastatin.html. Accessed January 18, 2019.
  • PRAVACHOL (Pravastatin) tablets [Prescribing Information]. Princeton, New Jersey 08543 USA; Bristol-Myers Squibb Company; 2014.
  • Garcia MJ, Reinoso RF, Sanchez Navarro A, Prous JR. Clinical pharmacokinetics of statins. Methods Find Exp Clin Pharmacol. 2003;25(6):457–481.12949632