The Clinical Pharmacogenetics Implementation Consortium Guideline for SLCO1B1 and Simvastatin-Induced Myopathy: 2014 Update

Clinical Pharmacology and Therapeutics

Volumn 96, Issue 4, 2014, Pages 423-428

  Ramsey, L B ^a   Johnson, S G ^b,c   Caudle, K E ^a   Haidar, C E ^a   Voora, D ^d   Wilke, R A ^e,f   Maxwell, W D ^g   McLeod, H L ^h   Krauss, R M ⁱ   Roden, D M ^j,k   Feng, Q ^j,k   Cooper Dehoff, R M ^l   Gong, L ^m   Klein, T E ^m   Wadelius, M ⁿ   Niemi, M ^o,p  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c KAISER PERMANENTE   (United States)

^d DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Sanford Health Medical Center   (United States)

^f UND School of Medicine & Health Sciences Southeast Campus   (United States)

^g University of South Carolina   (United States)

^h H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

ⁱ CHILDREN S HOSPITAL OAKLAND RESEARCH INSTITUTE   (United States)

^j VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^k VANDERBILT UNIVERSITY   (United States)

^l UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^m STANFORD UNIVERSITY   (United States)

ⁿ UPPSALA UNIVERSITY   (Sweden)

^o UNIVERSITY OF HELSINKI   (Finland)

^p KING ABDULAZIZ UNIVERSITY   (Saudi Arabia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; SIMVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ORGANIC ANION TRANSPORTER; SLCO1B1 PROTEIN, HUMAN;

DRUG EXPOSURE; GENE; GENOTYPE; GENOTYPE PHENOTYPE CORRELATION; HUMAN; MYOPATHY; PHARMACOGENETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SINGLE NUCLEOTIDE POLYMORPHISM; SLCO1B1 GENE; CHEMICALLY INDUCED; DRUG INTERACTION; GENETIC POLYMORPHISM; GENETICS; MUSCLE DISEASE;

DRUG INTERACTIONS; GENOTYPE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MUSCULAR DISEASES; ORGANIC ANION TRANSPORTERS; PHARMACOGENETICS; POLYMORPHISM, GENETIC; SIMVASTATIN;

EID: 84921691744     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2014.125     Document Type: Review

References (37)

1. Wilke, R.A. et al.; Clinical Pharmacogenomics Implementation Consortium (CPIC). The Clinical Pharmacogenomics Implementation Consortium: CPIC guideline for SLCO1B1 and simvastatin-induced myopathy. Clin. Pharmacol. Ther. 92, 112-117 (2012
2. Wilke, R.A. et al. Identifying genetic risk factors for serious adverse drug reactions: Current progress and challenges. Nat. Rev. Drug Discov. 6, 904-916 (2007
3. Buettner, C., Rippberger, M.J., Smith, J.K., Leveille, S.G., Davis, R.B. & Mittleman, M.A. Statin use and musculoskeletal pain among adults with and without arthritis. Am. J. Med. 125, 176-182 (2012
4. Wilke, R.A. & Dolan, M.E. Genetics and variable drug response. JAMA 306, 306-307 (2011
5. Ramsey, L.B. et al. Rare versus common variants in pharmacogenetics: SLCO1B1 variation and methotrexate disposition. Genome Res. 22, 1-8 (2012
6. Niemi, M., Pasanen, M.K. & Neuvonen, P.J. Organic anion transporting polypeptide 1B1: A genetically polymorphic transporter of major importance for hepatic drug uptake. Pharmacol. Rev. 63, 157-181 (2011
7. 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 15, 513-522 (2005
8. Tirona, R.G., Leake, B.F., Merino, G. & Kim, R.B. Polymorphisms in OATP-C: Identification of multiple allelic variants associated with altered transport activity among European-and African-Americans. J. Biol. Chem. 276, 35669-35675 (2001
9. Niemi, M. et al. High plasma pravastatin concentrations are associated with single nucleotide polymorphisms and haplotypes of organic anion transporting polypeptide-C (OATP-C, SLCO1B1). Pharmacogenetics 14, 429-440 (2004
10. Pasanen, M.K., Fredrikson, H., Neuvonen, P.J. & Niemi, M. Different effects of SLCO1B1 polymorphism on the pharmacokinetics of atorvastatin and rosuvastatin. Clin. Pharmacol. Ther. 82, 726-733 (2007
11. Pasanen, M.K., Neuvonen, M., Neuvonen, P.J. & Niemi, M. SLCO1B1 polymorphism markedly affects the pharmacokinetics of simvastatin acid. Pharmacogenet. Genomics 16, 873-879 (2006
12. Ho, R.H. et al. Drug and bile acid transporters in rosuvastatin hepatic uptake: Function, expression, and pharmacogenetics. Gastroenterology 130, 1793-1806 (2006
13. Niemi, M. Transporter pharmacogenetics and statin toxicity. Clin. Pharmacol. Ther. 87, 130-133 (2010
14. Kalliokoski, A. & Niemi, M. Impact of OATP transporters on pharmacokinetics. Br. J. Pharmacol. 158, 693-705 (2009
15. DeGorter, M.K. et al. Clinical and pharmacogenetic predictors of circulating atorvastatin and rosuvastatin concentrations in routine clinical care. Circ. Cardiovasc. Genet. 6, 400-408 (2013
16. Ramsey, L.B. et al. Genome-wide study of methotrexate clearance replicates SLCO1B1. Blood 121, 898-904 (2013
17. Van De Steeg, E. et al. Complete OATP1B1 and OATP1B3 deficiency causes human Rotor syndrome by interrupting conjugated bilirubin reuptake into the liver. J. Clin. Invest. 122, 519-528 (2012
18. Link, E. et al. SLCO1B1 variants and statin-induced myopathy-a genomewide study. N. Engl. J. Med. 359, 789-799 (2008
19. Heart Protection Study Collaborative Group; Bulbulia, R. et al. Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20,536 high-risk individuals: A randomised controlled trial. Lancet 378, 2013-2020 (2011
20. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: A randomised placebo-controlled trial. Lancet 360, 7-22 (2002
21. Voora, D. et al. The SLCO1B1∗5 genetic variant is associated with statininduced side effects. J. Am. Coll. Cardiol. 54, 1609-1616 (2009
22. Puccetti, L., Ciani, F. & Auteri, A. Genetic involvement in statins induced myopathy. Preliminary data from an observational case-control study. Atherosclerosis 211, 28-29 (2010
23. Brunham, L.R. et al. Differential effect of the rs4149056 variant in SLCO1B1 on myopathy associated with simvastatin and atorvastatin. Pharmacogenomics J. 12, 233-237 (2012
24. Stone, N.J. et 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. Circulation. 63, 2889-2934 (2014
25. Shuldiner, A.R. et al.; Pharmacogenomics Research Network Translational Pharmacogenetics Program Group. The Pharmacogenomics Research Network Translational Pharmacogenetics Program: Overcoming challenges of real-world implementation. Clin. Pharmacol. Ther. 94, 207-210 (2013
26. Wilke, R.A. et al. The emerging role of electronic medical records in pharmacogenomics. Clin. Pharmacol. Ther. 89, 379-386 (2011
27. Kullo, I.J., Jarvik, G.P., Manolio, T.A., Williams, M.S. & Roden, D.M. Leveraging the electronic health record to implement genomic medicine. Genet. Med. 15, 270-271 (2013
28. De Lemos, J.A. et al.; Investigators. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: Phase Z of the A to Z trial. JAMA 292, 1307-1316 (2004
29. Chung, J.Y. et al. Effect of OATP1B1 (SLCO1B1) variant alleles on the pharmacokinetics of pitavastatin in healthy volunteers. Clin. Pharmacol. Ther. 78, 342-350 (2005
30. Lee, E. et al. Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin. Pharmacol. Ther. 78, 330-341 (2005
31. Hippisley-Cox, J. & Coupland, C. Individualising the risks of statins in men and women in England and Wales: Population-based cohort study. Heart 96, 939-947 (2010
32. Thompson, P.D., Clarkson, P. & Karas, R.H. Statin-associated myopathy. JAMA 289, 1681-1690 (2003
33. McClure, D.L., Valuck, R.J., Glanz, M., Murphy, J.R. & Hokanson, J.E. Statin and statin-fibrate use was significantly associated with increased myositis risk in a managed care population. J. Clin. Epidemiol. 60, 812-818 (2007
34. Santos, P.C. et al. SLCO1B1 haplotypes are not associated with atorvastatininduced myalgia in Brazilian patients with familial hypercholesterolemia. Eur. J. Clin. Pharmacol. 68, 273-279 (2012
35. Carr, D.F. et al. SLCO1B1 genetic variant associated with statin-induced myopathy: A proof-of-concept study using the clinical practice research datalink. Clin. Pharmacol. Ther. 94, 695-701 (2013
36. Danik, J.S., Chasman, D.I., MacFadyen, J.G., Nyberg, F., Barratt, B.J. & Ridker, P.M. Lack of association between SLCO1B1 polymorphisms and clinical myalgia following rosuvastatin therapy. Am. Heart J. 165, 1008-1014 (2013
37. Graham, D.J. et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 292, 2585-2590 (2004).