Results of a safety initiative for patients on concomitant amiodarone and simvastatin therapy in a Veterans Affairs Medical Center

Journal of Managed Care Pharmacy

Volumn 16, Issue 7, 2010, Pages 472-481

  Karimi, Sahar ^a   Hough, Augustus ^b   Beckey, Cherylyn ^b   Parra, David ^b,c  

^a KAISER PERMANENTE   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c UNIVERSITY OF MINNESOTA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; AMIODARONE; AMPRENAVIR; ATAZANAVIR; CREATINE KINASE; CYCLOSPORIN; DARUNAVIR; DILTIAZEM; FENOFIBRATE; FOSAMPRENAVIR; GEMFIBROZIL; INDINAVIR; ITRACONAZOLE; KETOCONAZOLE; LIPID; LOPINAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MACROLIDE; NEFAZODONE; NICOTINIC ACID; PRAVASTATIN; PROTEINASE INHIBITOR; PYRROLE DERIVATIVE; RITONAVIR; ROSUVASTATIN; SAQUINAVIR; SIMVASTATIN; TIPRANAVIR; VERAPAMIL; ANTIARRHYTHMIC AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

AMINOTRANSFERASE BLOOD LEVEL; CREATINE KINASE BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; KIDNEY FUNCTION; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MYALGIA; MYOPATHY; PUBLIC HOSPITAL; REVIEW; RHABDOMYOLYSIS; RISK FACTOR; UNITED STATES; VETERAN; AGED; CHEMICALLY INDUCED; CLINICAL PRACTICE; DOSE RESPONSE; DRUG INTERACTION; DRUG LABELING; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; MUSCULAR DISEASES; RETROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA; VERY ELDERLY;

AGED; AGED, 80 AND OVER; AMIODARONE; ANTI-ARRHYTHMIA AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; DRUG LABELING; FEMALE; FOLLOW-UP STUDIES; HOSPITALS, VETERANS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MUSCULAR DISEASES; PHYSICIAN'S PRACTICE PATTERNS; QUALITY ASSURANCE, HEALTH CARE; RETROSPECTIVE STUDIES; RHABDOMYOLYSIS; RISK FACTORS; SIMVASTATIN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77958538072     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2010.16.7.472     Document Type: Review

References (39)

1. Pasternak RC, Smith SC, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C. ACC/AHA/NHLBI Clinical advisory on the use of and safety of statins. Circulation. 2002;106(8):1024-28. Available at: http://circ.ahajournals.org/cgi/ reprint/106/8/1024. Accessed August 2, 2010.
2. 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. 2002;360(9326):7-22. (Pubitemid 34756487)
3. Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998;279(20):1615-22. Available at: http://jama.ama- assn.org/cgi/reprint/279/20/1615. Accessed August 2, 2010.
4. Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995;333:1301-07. Available at: http://content.nejm.org/cgi/reprint/333/20/1301.pdf. Accessed August 2, 2010.
5. Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996;335(14):1001-09. Available at: http://content.nejm.org/cgi/reprint/335/14/ 1001.pdf. Accessed August 2, 2010.
6. LaRosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: a meta-analysis of randomized controlled trials. JAMA. 1999;282(24):2340-46. Available at: http://jama.ama-assn.org/cgi/reprint/282/24/ 2340. Accessed August 2, 2010.
7. No authors listed. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344(8934):1383-89.
8. No authors listed. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998;339(19):1349-57. Available at: http://content.nejm.org/cgi/reprint/339/19/1349.pdf. Accessed August 2, 2010.
9. Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med. 2009;150(12):858-68. Available at: http://www.annals.org/content/150/12/ 858.full.pdf+html. Accessed August 2, 2010.
10. Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006;114(25):2788-97. Available at: http://circ.ahajournals.org/cgi/reprint/114/ 25/2788. Accessed August 2, 2010.
11. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003;289(13):1681-90.
12. Jacobson TA. Toward "Pain-Free" statin prescribing: clinical algorithm for diagnosis and management of myalgia. Mayo Clin Proc. 2008;83(6):687-700. Available at: http://www.mayoclinicproceedings.com/content/ 83/6/687.full.pdf+html. Accessed August 2, 2010.
13. 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.
14. Ballantyne CM, Corsini A, Davidson MH, et al. Risk for myopathy with statin therapy in high-risk patients. Arch Intern Med. 2003;163(13):553-64. Available at: http://archinte.ama-assn.org/cgi/reprint/163/5/553. Accessed August 2, 2010.
15. U.S. Food and Drug Administration. Interaction between amiodarone (marketed as Cordarone and Pacerone) and simvastatin (marketed as Zocor and generics) or simvastatin-combination products (marketed as Vytorin and Simcor). Drug Safety Newsletter. 2008;1(4):46-48. Available at: www.fda.gov/downloads/ Drugs/DrugSafety/DrugSafetyNewsletter/ucm109178.pdf. Accessed August 2, 2010.
16. SEARCH Collaborative Group, Link E, Parish S, Armitage J, et al. SLCO1B1 variants and statin-induced myopathy - a genomewide study. N Engl Med. 2008;359(8):789-99. Available at: http://content.nejm.org/cgi/reprint/359/8/789. pdf. Accessed August 2, 2010.
17. Search Study Collaborative Group, Bowman L, Armitage J, Bulbulia R, Parish S, Collins R. Study of the effectiveness of additional reductions in cholesterol and homocysteine (SEARCH): characteristics of a randomized trial among 12064 myocardial infarction survivors. Am Heart J. 2007;154(5):815-23. Available at study website (trial-related documents, SEARCH baseline paper) at: www.searchinfo.org. Accessed August 2, 2010.
18. Bellosta S, Paoletti R, Corsini A. Safety of statins. Focus on clinical pharmacokinetics and drug interactions. Circulation. 2004:109(23 suppl):50-57. Available at: http://circ.ahajournals.org/cgi/reprint/109/23-suppl-1/III-50. Accessed August 2, 2010.
19. Pacerone (amiodarone HCl) tablets, 100 mg and 200 mg. Upsher-Smith. October 2009. Available at: http://www.upsher-smith.com/PDFs/Pacerone-PI.pdf. Accessed August 2, 2010.
20. Pravachol (pravastatin sodium) tablets. Bristol-Myers Squibb Company. March 2007. Available at: http://packageinserts.bms.com/pi/pi-pravachol.pdf. Accessed August 2, 2010.
21. Crestor (rosuvastatin calcium). AstraZeneca Pharmaceuticals LP. June 2010. Available at: http://www1.astrazeneca-us.com/pi/crestor.pdf. Accessed August 2, 2010.
22. Becquemont L, Neuvonen M, Verstuyft C, et al. Amiodarone interacts with simvastatin but not with pravastatin disposition kinetics. Clin Pharmacol Ther. 2007;81(5):679-84. (Pubitemid 46625102)
23. Merz T, Fuller SH. Elevated serum transaminase levels resulting from concomitant use of rosuvastatin and amiodarone. Am J Health Syst Pharm. 2007;64(17):1818-21.
24. Mevacor (lovastatin). Merck & Co, Inc. May 2010. Available at: http://www.merck.com/product/usa/pi-circulars/m/mevacor/mevacor-pi.pdf. Accessed August 2, 2010.
25. Lipitor (atorvastatin calcium) tablets. Pfizer Ireland Pharmaceuticals. June 2009. Available at: http://www.pfizer.com/files/products/uspi-lipitor.pdf. Accessed March 28, 2010.
26. Lescol (fluvastatin sodium) capsules. Novartis. October 2006. Available at: http://www.pharma.us.novartis.com/product/pi/pdf/Lescol.pdf. Accessed August 2, 2010.
27. Alsheikh-Ali AA, Karas RH. Adverse events with concomitant amiodarone and statin therapy. Prev Cardiol. 2005;8(2):95-97.
28. Jones PH, Davidson MH, Stein EA, et al.; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin and pravastatin across doses (STELLAR* Trial). Am J Cardiol. 2003;92(2):152-60.
29. World Health Organization. Global strategy on diet, physical activity and health: obesity and overweight. 2003. Available at: www.who.int/ dietphysicalactivity/publications/facts/obesity/en/. Accessed August 2, 2010.
30. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification and stratification. Am J Kidney Dis. 2002;39:S1-S26. Available at: http://www.kidney.org/professionals/ kdoqi/pdf/ckd-evaluation-classification-stratification.pdf. Accessed August 2, 2010.
31. Child-Turcotte-Pugh score - classification of liver dysfunction. Available at: http://www.globalrph.com/child-pugh.htm. Accessed August 2, 2010.
32. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption - II. Addiction. 1993;88(6):791-804.
33. Mayfield D, McLeod G, Hall P. The CAGE questionnaire: Validation of a new alcoholism screening instrument. Am J Psychiatry. 1974;131(10):1121-23.
34. Borders-Hemphill V. Concurrent use of statins and amiodarone. Consult Pharm. 2009;24(5):372-79.
35. Aoki Y, Belin RM, Clickner R, Jeffries R, Phillips L, Mahaffey KR. Serum TSH and total T4 in the United States population and their association with participant characteristics: National Health and Nutrition Examination Survey (NHANES 1999-2002). Thyroid. 2007;17(12):1211-23.
36. Hayashi T, Yokote K, Saito Y, Iguchi A. Pitavastatin: efficacy and safety in intensive lipid lowering. Expert Opin Pharmacother. 2007;8(14):2315-27.
37. Mukhtar RY, Reid J, Reckless JP. Pitavastatin. Int J Clin Pract. 2005;59(2):239-52.
38. Curtiss FR, Fairman KA. Quality improvement opportunities in prescriber alert programs. J Manag Care Pharm. 2010;16(4):292-96. Available at: http://www.amcp.org/data/jmcp/292-296.pdf.
39. U.S. Food and Drug Administration. FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. March 19, 2010. Available at http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm204882. htm#AdditionalInformationforHealthcareProfessionals2. Accessed August 2, 2010.