Combination therapy for dyslipidemia: Safety and regulatory considerations

American Journal of Cardiology

Volumn 90, Issue 10 SUPPL. 2, 2002, Pages 50-60

  Davidson, Michael H ^a  

^a RUSH MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; ATORVASTATIN; BILE ACID; CERIVASTATIN; COLESEVELAM; EZETIMIBE; FENOFIBRATE; FIBRIC ACID DERIVATIVE; FLUINDOSTATIN; GEMFIBROZIL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOVASTATIN PLUS NICOTINIC ACID; MEVINOLIN; NICOTINIC ACID; SIMVASTATIN; UBIQUINONE;

ARTICLE; CLINICAL PRACTICE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; DOSE RESPONSE; DRUG APPROVAL; DRUG MECHANISM; DRUG RELEASE; DRUG SAFETY; DYSLIPIDEMIA; FLUSHING; HUMAN; INCIDENCE; LIVER FUNCTION; LIVER TOXICITY; MYOPATHY; PRIORITY JOURNAL; RHABDOMYOLYSIS; RISK BENEFIT ANALYSIS; RISK FACTOR; SIDE EFFECT;

EID: 0037146230     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9149(02)02970-3     Document Type: Article

References (52)

1. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 157:1997;2413-2445.
2. National Drug Code Directory. US Food and Drug Administration. Center for Drug Evaluation and Research. Available at: http://www.fda.gov/cder/ndc/. Accessed: September 4, 2002.
3. Stein E.A. New statins and new doses of older statins. Curr Atheroscler Rep. 3:2000;14-28.
4. Brown A.S., Bakker-Arkema R.G., Yellen L., Henley R.W. Jr, Guthrie R., Campbell C.F., Koren M., Woo W., McLain R., Black D.M. Treating patients with documented atherosclerosis to National Cholesterol Education Program-recommended low-density-lipoprotein cholesterol goals with atorvastatin, fluvastatin, lovastatin and simvastatin. J Am Coll Cardiol. 32:1998;665-672.
5. Pasternak R.C., Smith S.C., Bairey-Merz C.N., Grundy S.M., Cleeman J.I., Lenfant C. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol. 40:2002;567-572.
6. Yusuf S., Sleight P., Pogue J., Bosch J., Davies R., Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med. 342:2000;145-153.
7. Dahlof B., Devereux R.B., Kjeldsen S.E., Julius S., Beevers G., Faire U., Fyhrquist F., Ibsen H., Kristiansson K., Lederballe-Pedersen O., et al. Cardiovascular morbidity and mortality in the Losartan Intervention for Endpoint reduction in hypertension study (LIFE) a randomised trial against atenolol . Lancet. 23:2002;995-1003.
8. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 285:2001;2486-2497.
9. Gebhard R.L., Ewing S.L., Schlasner L.A., Hunninghake D.B., Prigge W.F. Effect of 3-hydroxy-3-methyl coenzyme. A reductase inhibition on human gut mucosa. Lipids. 26:1991;492-494.
10. Di Mauro S., Bonilla E., Davidson M., Hirano M., Schon E.A. Mitochondria in neuromuscular disorders. Biochem Biophys Acta. 1366:1998;199-210.
11. Laaksonen R., Jokelainen K., Sahi T., Tikkanen M.J., Himberg J.J. Decreases in serum ubiquinone concentrations do not result in reduced levels in muscle tissue during short-term simvastatin treatments in humans. Clin Pharmacol Ther. 57:1995;62-66.
12. Simvastatin. Physician's Desk Reference. 2002;Medical Economics Company, MontVale, NJ.
13. Isaacsohn J., Black D., Troendle A., Orloff D. The impact of the National Cholesterol Education Program Adult Treatment Panel III guidelines on drug development. Am J Cardiol. 89:(suppl):2002;45C-49C.
14. Davidson M.H. Does differing metabolism by cytochrome P450 have clinical importance. Curr Atheroscler Rep. 2:2000;14-19.
15. Insull W. Jr, Isaacsohn J., Kwiterovich P., Ma P., Brazg R., Dujovne C. Efficacy and safety of cerivastatin 0.8 mg in patients with hypercholesterolemia the pivotal placebo-controlled clinical trial . J Int Med Res. 28:2000;47-68.
16. Atorvastatin. Physician's Desk Reference. 2002;Medical Economics Company, MontVale, NJ.
17. Jones P., Kafonek S., Hunninghake D. Comparative dose efficacy of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study). Am J Cardiol. 81:1998;582-587.
18. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals a randomised placebo-controlled trial . Lancet. 360:2002;7-22.
19. Schwartz G.G., Olsson A.G., Ezekowitz M.D., Ganz P., Oliver M.F., Waters D., Zeiher A., Chaitman B.R. Effects of atorvastatin on early recurrent ischaemic events in acute coronary syndromes. The MIRACL study a randomized controlled trial . JAMA. 285:2001;1711-1718.
20. Kosoglou T., Meyer I., Musiol B., Mellars L., Statkevich P., Miller M.F., Soni P.P., Affrime M.B. Pharmacodynamic interaction between the new selective cholesterol absorption inhibitor ezetimibe and simvastatin. [abstract] Atherosclerosis. 151:2000;135.
21. Davidson M.H., Dicklin M.R., Maki K.C., Kleinpell R.M. Colesevelam hydrochloride a non-absorbed, polymeric cholesterol-lowering agent . Opin Invest Drugs. 9:2000;2663-2671.
22. Bradford R.H., Shear C.L., Chermos A.N., Dujovne C.A., Franklin F.A., Grillo R.B., Higgins J., Langendorfer A., Nash D.T., Pool J.L. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolaemia. Arch Intern Med. 151:1991;43-49.
23. Davidson M.H., Stein E.A., Dujovne C.A., Hunninghake D.B., Weiss S.R., Knopp R.H., Illingworth D.R., Mitchel Y.B., Melino M.R., Zupkis R.V., Dobrinska M.R., Amin R.D., Tobert J.A. The efficacy and six-week tolerability of simvastatin 80 and 160 mg/day. Am J Cardiol. 257:1997;38-42.
24. Backman J.T., Kyrklund C., Kivisto K.T., Wang J.S., Neuvonen P.J. Plasma concentrations of active simvastatin acid are increased by gemfibrozil. Clin Pharmacol Ther. 68:2000;122-129.
25. Corsini A., Bellosta S., Baetta R., Fumagalli R., Paoletti R., Bernini F. New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol Ther. 84:1999;413-428.
26. Pravastatin. Physician's Desk Reference. 2002;Medical Economics Company, MontVale, NJ.
27. Davidson M.H. Controversy surrounding the safety of cerivastatin. Expert Opinions in Drug Safety. 1:2002;207-212.
28. Davidson M.H. Rosuvastastin a highly efficacious statin for the treatment of dyslipidaemia . Expert Opin Investig Drugs. 11:2002;125-141.
29. Spence J.D., Munoz C.E., Hendricks L., Latchinian L., Khouri H.E. Pharmacokinetics of the combination of fluvastatin and gemfibrozil. Am J Cardiol. 76:1995;80A-83A.
30. Pan W.J., Gustavson L.E., Achari R., Rieser M.J., Ye X., Gutterman C., Wallin B.A. Lack of a clinically significant pharmacokinetic interaction between fenofibrate and pravastatin in healthy volunteers. J Clin Pharmacol. 40:2000;316-323.
31. Herman R.J. Drug interactions and the statins. CMAJ. 161:1999;1281-1286.
32. Wen X., Wang J.S., Backman J.T., Kivisto K.T., Neuvonen P.J. Gemfibrozil is a potent inhibitor of human cytochrome P450 2C9. Drug Metab Dispos. 29:2001;1359-1361.
33. Prueksaritanont T., Zhao J.J., Ma B., Roadcap B.A., Tang C., Ziu Y., Liu L., Lin J.H., Pearson P.G., Baillie T.A. Mechanistic studies on metabolic interactions between gemfibrozil and statins. J Pharmacol Exp Ther. 301:2002;1042-1051.
34. Evans M., Rees A. The myotoxicity of statins. Curr Opin Lipidol. 13:2002;415-420.
35. Gupta E.K., Ito M.K. Lovastatin and extended-release niacin combination product the first drug combination for the management of hyperlipidemia . Heart Dis. 4:2002;124-137.
36. Reaven P., Witztum J.L. Lovastatin, nicotinic acid, and rhabdomyolysis. Ann Intern Med. 109:1988;597-598.
37. McKenney J.M., Proctor J.D., Harris S., Chinchili V.M. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA. 271:1994;672-677.
38. Data on file. 2002;Merck-Schering Plough, Whitehouse Station, NJ.
39. Goldberg A., Alagona P. Jr, Capuzzi D.M., Guyton J., Morgan J.M., Rodgers J., Sachson R., Samuel P. Multiple-dose efficacy and safety of an extended-release form of niacin in the management of hyperlipidemia. Am J Cardiol. 85:2000;1100-1105.
40. Guyton J.R., Goldberg A.C., Kreisberg R.A., Sprecher D.L., Superko H.R., O'Connor C.M. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol. 82:1998;737-743.
41. Wolfe M.L., Vartanian S.F., Ross J.L., Bansavich L.L., Mohler E.R. III, Meagher E., Friedrich C., Rader D.J. Safety and effectiveness of extended-release niacin when added sequentially to a statin for treatment of dyslipidemia. Am J Cardiol. 87:2001;476-479.
42. Kashyap M.L., Evans R., Simmons P.D., Kohler R.M., McGovern M.E. New combination niacin/statin formulation shows pronounced effects on major lipoproteins and is well tolerated. [abstract] J Am Coll Cardiol. 35:(suppl A):2000;326A.
43. Omar M.A., Wilson J.P., Cox T.S. Rhabdomyolysis and HMG-CoA reductase inhibitors. Ann Pharmacother. 35:2001;1096-1107.
44. Data on file. 2002;Kos Pharmaceutical Company, Miami, FL.
45. Wiklund O., Angelin B., Bergman M., Berglund L., Bondjers G., Carlsson A., Linden T., Miettinen T., Odman B., Olofsson S.O., et al. Pravastatin and gemfibrozil alone and in combination for the treatment of hypercholesterolemia. Am J Med. 94:1993;13-20.
46. Ellen R.L., McPherson R. Long-term efficacy and safety of fenofibrate and a statin in the treatment of combined hyperlipidemia. Am J Cardiol. 81:1998;60B-65B.
47. Pierce L.R., Wysowski D.K., Gross T.P. Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. JAMA. 264:1990;71-75.
48. Hanston D., Horn J.R. Drug interactions with HMG CoA reductase inhibitors. Drug Interactions Newsletter. 103:1998;103-106.
49. Rosenson R.S., Frauenheim W.A. Safety of combined pravastatin-gemfibrozil therapy. Am J Cardiol. 74:1994;499-500.
50. Murdock D.K., Murdock A.K., Murdock R.W., Olson K.J., Frane A.M., Kersten M.E., Joyce D.M., Gantner S.E. Long-term safety and efficacy of combination gemfibrozil and HMB-CoA reductase inhibitors for the treatment of mixed lipid disorders. Am Heart J. 138:1999;151-155.
51. Iliadis E.A., Rosenson R.S. Long-term safety of pravastatin-gemfibrozil therapy in mixed hyperlipidemia. Clin Cardiol. 22:1999;25-28.
52. Data on file. Bayer Pharmaceutical Company, West Haven, CT.