Rhabdomyolysis reports show interaction between simvastatin and CYP3A4 inhibitors

Pharmacoepidemiology and Drug Safety

Volumn 18, Issue 4, 2009, Pages 301-309

  Rowan, Christopher ^a   Brinker, Allen D ^b   Nourjah, Parivash ^b   Chang, Jennie ^b   Mosholder, Andrew ^b   Barrett, Jeffrey S ^c   Avigan, Mark ^b  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b Center for Drug Evaluation and Research   (United States)

^c CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

Author keywords

Adverse reactions; CYP3A4 inhibitors; HMG CoA reductase inhibitors; Interaction; Rhabdomyolysis; Spontaneous reports; Statins

Indexed keywords

CLARITHROMYCIN; CREATINE KINASE; CYCLOSPORIN; CYTOCHROME P450 3A4 INHIBITOR; CYTOCHROME P450 INHIBITOR; DILTIAZEM; ERYTHROMYCIN; FLUCONAZOLE; FLUVOXAMINE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ITRACONAZOLE; KETOCONAZOLE; MIBEFRADIL; NEFAZODONE; PRAVASTATIN; SIMVASTATIN; UNCLASSIFIED DRUG; VERAPAMIL; CYP3A4 PROTEIN, HUMAN; CYTOCHROME P450 3A; ENZYME INHIBITOR;

ADULT; AGED; ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DISEASE ASSOCIATION; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG SELECTIVITY; FEMALE; HUMAN; INCIDENCE; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RHABDOMYOLYSIS; RISK ASSESSMENT; CHEMICALLY INDUCED DISORDER; DRUG INTERACTION; DRUG SURVEILLANCE PROGRAM; METABOLISM; MIDDLE AGED; RISK FACTOR;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; CYTOCHROME P-450 CYP3A; DRUG INTERACTIONS; ENZYME INHIBITORS; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; PRAVASTATIN; RHABDOMYOLYSIS; RISK ASSESSMENT; RISK FACTORS; SIMVASTATIN; YOUNG ADULT;

EID: 65449181616     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1711     Document Type: Article

References (34)

1. Smith SC, Allen J, Blair SN, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update - Endorsed by the National Heart, Lung, and Blood Institute. Circulation 2006; 113(19): 2363-2372.
2. Ucar M, Mjorndal T, Dahlqvist R. HMG-CoA reductase inhibitors and myotoxicity. Drug Saf 2000; 22(6): 441-457.
3. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med 2002; 346(7): 539-540.
4. Koga T, Fukuda K, Shimada Y, et al. Tissue selectivity of pravastatin sodium, lovastatin and simvastatin - the relationship between inhibition of denovo sterol synthesis and active-drug concentrations in the liver, spleen and testis in rat. Eur J Biochem 1992; 209(1): 315-319.
5. Shitara Y, Sugiyama Y. Pharmacokinetic and, pharmacodynamic alterations of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors: drug-drug interactions and interindividual differences in transporter and metabolic enzyme functions. Pharmacol. Ther. 2006; 112(1): 71-105.
6. Vickers S, Duncan CA, Chen IW, et al. Metabolic disposition studies on simvastatin, a cholesterol-lowering prodrug. Drug Metab Dispos 1990; 18(2): 138-145.
7. Pan HY, Devault AR, Wangiverson D, et al. Comparative pharmacokinetics and pharmacodynamics of pravastatin and lovastatin. J Clin Pharmacol 1990; 30(12): 1128-1135.
8. Pentikainen PJ, Saraheimo M, Schwartz JI, et al. Comparative pharmacokinetics of lovastatin, simvastatin and pravastatin in humans. J Clin Pharmacol 1992; 32(2): 136-140.
9. Cilla DD, Whitfield LR, Gibson DM, et al. Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects. Clin Pharmacol Ther 1996; 60(6): 687-695.
10. McTaggart F, Buckett L, Davidson R, et al. Preclinical and clinical pharmacology of rosuvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. Am J Cardiol 2001; 87(5A): 28B-32B.
11. Hsiang BN, Zhu YJ, Wang ZQ, et al. A novel human hepatic organic anion transporting polypeptide (OATP2) - Identification of a liverspecific human organic anion transporting polypeptide and identification of rat and human hydroxymethylglutaryl-CoA reductase inhibitor transporters. J Biol Chem 1999; 274(52): 37161-37168.
12. Ho RH, Tirona RG, Leake BF, et al. Drug and bile acid transporters in rosuvastatin hepatic uptake: function, expression, and pharmacogenetics. Gastroenterology 2006; 130(6): 1793-1806.
13. Fischer V, Johanson L, Heitz F, et al. The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor fluvastatin: effect on human cytochrome P-450 and implications for metabolic drug interactions. Drug Metab Dispos 1999; 27(3): 410-416.
14. Nakai D, Nakagomi R, Furuta Y, et al. Human liver-specific organic anion transporter, LST-1, mediates uptake of pravastatin by human hepatocytes. J Pharmacol Exp Ther 2001; 297(3): 861-867.
15. 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.
16. Kantola T, Kivisto KT, Neuvonen PJ. Effect of itraconazole on the pharmacokinetics of atorvastatin. Clin Pharmacol Ther 1998; 64(1): 58-65.
17. Wang JS, Neuvonen M, Wen X, et al. Gemfibrozil inhibits CYP2C8mediated cerivastatin metabolism in human liver microsomes. Drug Metab Dispos 2002; 30(12): 1352-1356.
18. Schneck DW, Birmingham BK, Zalikowski JA, et al. The effect of gemfibrozil on the pharmacokinetics of rosuvastatin. Clin Pharmacol Ther 2004; 75(5): 455-463.
19. Chen CP, Mireles RJ, Campbell SD, et al. Differential interaction of 3hydroxy- 3-methylglutaryl-COA reductase inhibitors with ABCB1, ABCC2, and OATP1 B1. Drug Metab Dispos 2005; 33(4): 537-546.
20. Shitara Y, Hirano M, Sato H, et al. Gemfibrozil and its glucuronide inhibit the organic anion transporting polypeptide 2 (OATP2/ OATP1 B1:SLC21A6)-mediated hepatic uptake and CYP2C8-mediated metabolism of cerivastatin: analysis of the mechanism of the clinically relevant drug-drug interaction between cerivastatin and gemfibrozil. J Pharmacol Exp Ther 2004; 311(1): 228-236.
21. Shitara Y, Itoh T, Sato H, et al. Inhibition of transporter-mediated hepatic uptake as a mechanism for drug-drug interaction between cerivastatin and cyclosporin A. J Pharmacol Exp Ther 2003; 304(2): 610-616.
22. Olbricht C,Wanner C, Eisenhauer T, et al. Accumulation of lovastatin, but not pravastatin, in the blood of cyclosporine-treated kidney graft patients after multiple doses. Clin Pharmacol Ther 1997; 62(3): 311-321.
23. Prueksaritanont T, Ma B, Tang C, et al. Metabolic interactions between mibefradil and HMG-CoA reductase inhibitors: an in vitro investigation with human liver preparations. Br J Clin Pharmacol 1999; 47(3): 291-298.
24. Neuvonen PJ, Jalava KM. Itraconazole drastically increases plasma concentrations of lovastatin and lovastatin acid. Clin Pharmacol Ther 1996; 60(1): 54-61.
25. Flockhart D. Drug interactions: cytochrome P450 drug interaction table: Indiana University School of Medicine 2007.
26. Gonzalez FJ, Tukey RH. Chapter 3. Drug Metabolism. Brunton LL, Lazo JS, Parker KL: Goodman & Gilman's The Pharmacological Basis of Therapeutics, (11th edn).
27. Davidson MH, Gandhi SK, Ming EE, et al. Concomitant prescribing rates of statins and Cytochrome P450 3A4 inhibitors and inducers in real-world clinical practice. Pharmacoepidemiol Drug Saf 2006; 15: S289-S289.
28. Lee AJ, Maddix DS. Rhabdomyolysis secondary to a drug interaction between simvastatin and clarithromycin. Ann Pharmacother 2001; 35(1): 26-31.
29. Jacobson RH, Wang P, Glueck CJ. Myositis and rhabdomyolysis associated with concurrent use of simvastatin and nefazodone. JAMA 1997; 277(4): 296-296.
30. Ronaldson KJ, O'Shea JM, Boyd IW. Risk factors for rhabdomyolysis with simvastatin and atorvastatin. Drug Saf 2006; 29(11): 1061-1067.
31. Pasanen MK, Neuvonen M, Neuvonen PJ, et al. SLCO1B1 polymorphism markedly affects the pharmacokinetics of simvastatin acid. Pharmacogenet Genomics 2006; 16(12): 873-879.
32. Nakagomi-Hagihara R, Nakai D, Tokui T, Abe T, Ikeda T. Gemfibrozil and its glucuronide inhibit the hepatic uptake of pravastatin mediated by OATP1 B1. Xenobiotica 2007; 37(5): 474-486.
33. Brinker A, Beitz J. Use of a spontaneous adverse drug events database for identification of unanticipated drug benefits. Clin Pharmacol Ther 2002; 71(1): 99-102.
34. Chang JT, Staffa JA, Parks M, Green L. Rhabdomyolysis with HMGCoA reductase inhibitors and gemfibrozil combination therapy. Pharmacoepidemiol Drug Saf. 2004; 13(7): 417-426.