ABCG2 Gene Polymorphisms as Risk Factors for Atorvastatin Adverse Reactions: A Case–Control Study

References

• Stone NJ , RobinsonJG , LichtensteinAHet al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines . Circulation129 ( 25 Suppl. 2 ), S1 – S45 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• National Institute for Clinical Excellence . Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease . NICE guidelines CG181 , London, UK ( 2014 ). www.nice.org.uk/guidance/cg181/resources/guidance-lipid-modification-cardiovascular-risk-assessment-and-the-modification-of-blood-lipids-for-the-primary-and-secondary-prevention-of-cardiovascular-disease-pdf .
   Google Scholar
• Mancini GB , BakerS , BergeronJet al. Diagnosis, prevention, and management of statin adverse effects and intolerance: proceedings of a Canadian Working Group Consensus Conference . Can. J. Cardiol.27 ( 5 ), 635 – 662 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Pasternak RC , SmithSC , Bairey-MerzCN , GrundySM , CleemanJI , LenfantC . ACC/AHA/NHLBI clinical advisory on the use and safety of statins. American College of Cardiology; American Heart Association; National Heart, Lung and Blood Institute . J. Am. Coll. Cardiol.40 ( 3 ), 567 – 572 ( 2002 ).
   PubMed Web of Science ®Google Scholar
• Chatzizisis YS , KoskinasKC , MisirliG , VaklavasC , HatzitoliosA , GiannoglouGD . Risk factors and drug interactions predisposing to statin-induced myopathy: implications for risk assessment, prevention and treatment . Drug Saf.33 ( 3 ), 171 – 187 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Neuvonen PJ , NiemiM , BackmanJT . Drug interactions with lipid-lowering drug: mechanisms and clinical relevance . Clin. Pharmacol. Ther.80 ( 6 ), 565 – 581 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Niemi M . Transporter pharmacogenetics and statin toxicity . Clin. Pharmacol. Ther.87 ( 1 ), 130 – 133 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Keskitalo JE , ZolkO , FrommMF , KurkinenKJ , NeuvonenPJ , NiemiM . ABCG2 polymorphism markedly affects the pharmacokinetics of atorvastatin and rosuvastatin . Clin. Pharmacol. Ther.86 ( 2 ), 197 – 203 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Link E , ParishS , ArmitageJet al. SLCO1B1 variants and statin-induced myopathy – a genomewide study . N. Engl. J. Med.359 ( 8 ), 789 – 799 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Voora D , ShahSH , SpasojevicIet al. The SLCO1B1*5 genetic variant is associated with statin-induced side effects . J. Am. Coll. Cardiol.54 ( 17 ), 1609 – 1616 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Donnelly LA , DoneyAS , TavendaleRet al. Common nonsynonymous substitutions in SLCO1B1 predispose to statin intolerance in routinely treated individuals with Type 2 diabetes: a go-DARTS study . Clin. Pharmacol. Ther.89 ( 2 ), 210 – 216 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Puccetti L , CianiF , AuteriA . Genetic involvement in statins induced myopathy. Preliminary data from an observational case-control study . Atherosclerosis211 , 28 – 29 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Brunham LR , LansbergPJ , ZhangLet al. Differential effect of the rs4149056 variant in SLCO1B1 on myopathy associated with simvastatin and atorvastatin . Pharmacogenomics J.12 ( 3 ), 233 – 237 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Ramsey LB , JohnsonSG , CaudletKEet al. The clinical pharmacogenomics implementation consortium: CPIC guideline for SLCO1B1 and simvastatin-induced myopathy: 2014 update . Clin. Pharmacol. Ther.96 ( 4 ), 423 – 428 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Miroševic Skvrce N , BožinaN , ZibarL , BarišicI , PejnovicL , Macolic ŠarinicV . CYP2C9 and ABCG2 polymorphisms as risk factors for developing adverse drug reactions in renal transplant patients taking fluvastatin: a case–control study . Pharmacogenomics14 ( 12 ), 1419 – 1431 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Ferrari M , GuastiL , MarescaAet al. Association between statin-induced creatine kinase elevation and genetic polymorphisms in SLCO1B1, ABCB1 and ABCG2 . Eur. J. Clin. Pharmacol.70 ( 5 ), 539 – 547 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Park JE , KimKB , BaeSK , MoonBS , LiuKH , ShinJG . Contribution of cytochrome P450 3A4 and 3A5 to the metabolism of atorvastatin . Xenobiotica38 ( 9 ), 1240 – 1251 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Wang D , GuoY , WrightonSA , CookeGE , SadeeW . Intronic polymorphism in CYP3A4 affects hepatic expression and response to statin drugs . Pharmacogenomics J.11 ( 4 ), 274 – 286 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Elens L , BeckerML , HaufroidVet al. Novel CYP3A4 intron 6 single nucleotide polymorphism is associated with simvastatin-mediated cholesterol reduction in the Rotterdam Study . Pharmacogenet. Genomics21 ( 12 ), 861 – 866 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Ballantyne CM , BlazingMA , HunninghakeDBet al. Effect on high-density lipoprotein cholesterol of maximum dose simvastatin and atorvastatin in patients with hypercholesterolemia: results of the Comparative HDL Efficacy and Safety Study (CHESS) . Am. Heart J.146 ( 5 ), 862 – 869 ( 2003 ).
   PubMed Web of Science ®Google Scholar
• Illingworth DR , CrouseJR3rd , HunninghakeDBet al. A comparison of simvastatin and atorvastatin up to maximal recommended doses in a large multicenter randomized clinical trial . Curr. Med. Res. Opin.17 ( 1 ), 43 – 50 ( 2001 ).
   PubMed Web of Science ®Google Scholar
• Omar MA , WilsonJP , CoxTS . Rhabdomyolysis and HMG-CoA reductase inhibitors . Ann. Pharmacother.35 ( 9 ), 1096 – 1107 ( 2001 ).
   PubMed Web of Science ®Google Scholar
• Armitage J . The safety of statins in clinical practice . Lancet370 ( 9601 ), 1781 – 1790 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Karch FE , LasagnaL . Adverse drug reactions. A critical review . JAMA234 ( 12 ), 1236 – 1241 ( 1975 ).
   PubMed Web of Science ®Google Scholar
• Danan G , BenichouC . Causality assessment of adverse reactions to drugs – I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries . J. Clin. Epidemiol.46 ( 11 ), 1323 – 1330 ( 1993 ).
   PubMed Web of Science ®Google Scholar
• ICH E2A guideline: note for guidance on clinical safety data management: definitions and standards for expedited reporting . In : CPMP/ICH/377/95 . European Agency for the Evaluation of Medicinal Products (EMEA) , London, UK , 1 – 10 ( 1995 ). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002749.pdf .
   Google Scholar
• Council for International Organizations of Medical Sciences . Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V . CIOMS , Geneva, Switzerland ( 2001 ).
   Google Scholar
• Alfirevic A , NeelyD , ArmitageJet al. Phenotype standardization for statin-induced myotoxicity . Clin. Pharmacol. Ther.96 ( 4 ), 470 – 476 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Law M , RudnickaAR . Statin safety: a systematic review . Am. J. Cardiol.97 ( 8A ), C52 – C60 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Aithal GP , WatkinsPB , AndradeRJet al. Case definition and phenotype standardization in drug-induced liver injury . Clin. Pharmacol. Ther.89 ( 6 ), 806 – 815 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Baxter K . Stockley’s drug interactions . Pharmaceutical Press , London, UK . www.medicinescomplete.com .
   Google Scholar
• Robey RW , IeranoC , ZhanZ , BatesSE . The challenge of exploiting ABCG2 in the clinic . Curr. Pharm. Biotechnol.12 ( 4 ), 595 – 608 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Wang B , WangJ , HuangSQ , SuHH , ZhouSF . Genetic polymorphism of the human cytochrome P450 2C9 gene and its clinical significance . Curr. Drug Metab.10 ( 7 ), 781 – 834 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• He SM , ZhouZW , LiXT , ZhouSF . Clinical drugs undergoing polymorphic metabolism by human cytochrome P450 2C9 and the implication in drug development . Curr. Med. Chem.18 ( 5 ), 667 – 713 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Holstein A , HahnM , PatzerO , SeeringerA , KovacsP , StinglJ . Impact of clinical factors and CYP2C9 variants for the risk of severe sulfonylurea-induced hypoglycemia . Eur. J. Clin. Pharmacol.67 ( 5 ), 471 – 476 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Kamiyama E , YoshigaeY , KasuyaA , TakeiM , KuriharaA , IkedaT . Inhibitory effects of angiotensin receptor blockers on CYP2C9 activity in human liver microsomes . Drug Metab. Pharmacokinet.22 ( 4 ), 267 – 275 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Taavitsainen P , KiukaanniemiK , PelkonenO . In vitro inhibition screening of human hepatic P450 enzymes by five angiotensin-II receptor antagonists . Eur. J. Clin. Pharmacol.56 ( 2 ), 135 – 140 ( 2000 ).
   PubMed Web of Science ®Google Scholar
• Wen X , WangJS , BackmanJT , LaitilaJ , NeuvonenPJ . Trimethoprim and sulfamethoxazole are selective inhibitors of CYP2C8 and CYP2C9, respectively . Drug Metab. Dispos.30 ( 6 ), 631 – 635 ( 2002 ).
   PubMed Web of Science ®Google Scholar
• Enokizono J , KusuharaH , SugiyamaY . Regional expression and activity of breast cancer resistance protein (Bcrp/Abcg2) in mouse intestine: overlapping distribution with sulfotransferases . Drug Metab. Dispos.35 ( 6 ), 922 – 928 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Takara K , SakaedaT , KakumotoMet al. Effects of alpha-adrenoceptor antagonist doxazosin on MDR1-mediated multidrug resistance and transcellular transport . Oncol. Res.17 ( 11–12 ), 527 – 533 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Adkison KK , VaidyaSS , LeeDYet al. Oral sulfasalazine as a clinical BCRP probe substrate: pharmacokinetic effects of genetic variation (C421A) and pantoprazole coadministration . J. Pharm. Sci.99 ( 2 ), 1046 – 1062 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Breedveld P , ZelcerN , PluimDet al. Mechanism of the pharmacokinetic interaction between methotrexate and benzimidazoles: potential role for breast cancer resistance protein in clinical drug-drug interactions . Cancer. Res.64 ( 16 ), 5804 – 5811 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Suzuki K , DokiK , HommaMet al. Co-administration of proton pump inhibitors delays elimination of plasma methotrexate in high-dose methotrexate therapy . Br. J. Clin. Pharmacol.67 ( 1 ), 44 – 49 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Miller SA , DykesDD , PoleskyHF . A simple salting out procedure for extracting DNA from human nucleated cells . Nucleic Acids Res.16 ( 3 ), 1215 ( 1998 ).
   Web of Science ®Google Scholar
• Haque KA , PfeifferRM , BeermanMB , StruewingJP , ChanockSJ , BergenAW . Performance of high-throughput DNA quantification methods . BMC Biotechnol.3 , 20 ( 2003 ).
   PubMed Web of Science ®Google Scholar
• Guo SW , ThompsonEA . A Monte Carlo method for combined segregation and linkage analysis . Am. J. Hum. Genet.51 ( 5 ), 1111 – 1126 ( 1992 ).
   PubMed Web of Science ®Google Scholar
• Slatkin M , ExcoffierL . Testing for linkage disequilibrium in genotypic data using the Expectation-Maximization algorithm . Heredity (Edinb.)76 ( Pt 4 ), 377 – 383 ( 1996 ).
   PubMedGoogle Scholar
• Excoffier L , LischerHE . Arlequin suite ver 3.5: a new series of programs to perform population genetics analyses under Linux and Windows . Mol. Ecol. Resour.10 ( 3 ), 564 – 567 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Hosmer DW , LemeshowS , SturdivantRX . In : Applied Logistic Regression (3rd Edition) . John Wiley & Sons Inc. , NJ, USA ( 2013 ).
   Google Scholar
• Andrew F Hayes, “Process”, release 2.12 . The Ohio State University , USA ( 2014 ). www.afhayes.com .
   Google Scholar
• R Core Team . R: a language and environment for statistical computing . R Foundation for Statistical Computing , Vienna, Austria ( 2013 ). www.R-project.org .
   Google Scholar
• Fujino H , SaitoT , OgawaS , KojimaJ . Transporter-mediated influx and efflux mechanisms of pitavastatin, a new inhibitor of HMG-CoA reductase . J. Pharm. Pharmacol.57 ( 10 ), 1305 – 1311 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• Kitamura S , MaedaK , WangY , SugiyamaY . Involvement of multiple transporters in the hepatobiliary transport of rosuvastatin . Drug Metab. Dispos.36 ( 10 ), 2014 – 2023 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Keskitalo JE , PasanenMK , NeuvonenPJ , NiemiM . Different effects of the ABCG2 c.421C>A SNP on the pharmacokinetics of fluvastatin, pravastatin and simvastatin . Pharmacogenomics10 ( 10 ), 1617 – 1624 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Niemi M . Transporter pharmacogenetics and statin toxicity . Clin. Pharmacol. Ther.87 ( 1 ), 130 – 133 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Robey RW , ToKK , PolgarOet al. ABCG2: a perspective . Adv. Drug Deliv. Rev.61 ( 1 ), 3 – 13 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Scarpini F , CappelloneR , AuteriA , PuccettiL . Role of genetic factors in statins side-effects . Cardiovasc. Hematol. Disord. Drug Targets12 ( 1 ), 35 – 43 ( 2012 ).
   PubMedGoogle Scholar
• Canestaro WJ , BrooksDG , ChaplinDet al. Statin pharmacogenomics: opportunities to improve patient outcomes and healthcare . J. Pers. Med.2 ( 4 ), 158 – 174 ( 2012 ).
   PubMedGoogle Scholar
• Bloss CS , MadlenskyL , SchorkNJ , TopolEJ . Genomic information as a behavioral health intervention: can it work?Per. Med.8 ( 6 ), 659 – 667 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Charland S , AgatepBC , EpsteinRSet al. Patient knowledge of pharmacogenetic information improves adherence to statin therapy: results of the additional KIF6 risk offers better adherence to statins (AKROBATS) trial . J. Am. Coll. Cardiol.59 , E1848 – E1848 ( 2012 ).
   Web of Science ®Google Scholar
• Santos PC , GagliardiAC , MinameMHet al. SLCO1B1 haplotypes are not associated with atorvastatin-induced myalgia in Brazilian patients with familial hypercholesterolemia . Eur. J. Clin. Pharmacol.68 ( 3 ), 273 – 279 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• McClure DL , ValuckRJ , GlanzM , MurphyJR , HokansonJE . Statin and statin-fibrate use was significantly associated with increased myositis risk in a managed care population . J. Clin. Epidemiol.60 ( 8 ), 812 – 818 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Ragia G , KolovouV , TavridouAet al. No effect of CYP3A4 intron 6 C>T polymorphism (CYP3A4*22) on lipid-lowering response to statins in Greek patients with primary hypercholesterolemia . Drug Metabol. Personal. Ther.30 ( 1 ), 43 – 48 ( 2015 ).
   PubMedGoogle Scholar
• Leusink M , de KeyserCE , Onland-MoretNCet al. No association between CYP3A4*22 and statin effectiveness in reducing the risk for myocardial infarction . Pharmacogenomics15 ( 11 ), 1471 – 1477 ( 2014 ).
   PubMed Web of Science ®Google Scholar
• Hoenig MR , WalkerPJ , GurnseyC , BeadleK , JohnsonL . The C3435T polymorphism in ABCB1 influences atorvastatin efficacy and muscle symptoms in a high-risk vascular cohort . J. Clin. Lipidol.5 ( 2 ), 91 – 96 ( 2011 ).
   PubMed Web of Science ®Google Scholar