Controversy surrounding the safety of cerivastatin

Bibliography

• STAFFA JA, CHANG J, GREEN L: Cerivastatin and reports of fatal rhabdomyolysis. N Engl. J. Med. (2002) 346:539–540.
   PubMed Web of Science ®Google Scholar
• ••This brief report reviews the FDA'srationale for withdrawing cerivastatin from the US market.
   Google Scholar
• PASTERNAK RC, SMITH SC, BAIREY-MERZ CN, GRUNDY SM, CLEEMAN JI, LENFANT C: ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Amer. Coll. Cardiol. (2002) 40:568–573.
   Web of Science ®Google Scholar
• ••This is a comprehensive review of the adverse effects of statins and provides recommendations for improving safety.
   Google Scholar
• PHYSICANS' DESK REFERENCE: Zocor, Merck & Co., p2221.
   Google Scholar
• PHYSICIANS' DESK REFERENCE: Lipitor, Pfizer, p2697.
   Google Scholar
• CORSINI A, BELLOSTA S, BAETTA R, FUMAGALLI R, PAOLETTI R, BERNINI F: New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacol Ther. (1999) 84:413–428.
   PubMed Web of Science ®Google Scholar
• •A comprehensive review of the pharmacokinetics of statins that differentiates the profile of cerivastatin compared to other statins.
   Google Scholar
• INSULL W JR, ISAACSOHN J, KWITEROVICH P, MAP, 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. (2000) 28:47–68.
   Google Scholar
• •This study identifies the higher myopathy rate of cerivastatin in elderly women.
   Google Scholar
• OMAR MA, WILSON JP, COX TS: Rhabdomyolysis and HMG-CoA reductase inhibitors. Ann. Pharmacother. (2001) 35:1096–1107.
   PubMed Web of Science ®Google Scholar
• •A comprehensive review of the FDA Adverse Event Report database on statins and highlights the medical myotoxicity of cerivastatin compared to other statins.
   Google Scholar
• 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 (2002) 89(Suppl.):45C–49C.
   Google Scholar
• ••The FDA's position on drug developmentissues that relate to the safety of combination therapy and the incidence of myopathy.
   Google Scholar
• NO AUTHORS LISTED: 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 (2001) 285:2486–2497.
   PubMed Web of Science ®Google Scholar
• NO AUTHORS LISTED: MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet (2002) 360:7–22.
   PubMed Web of Science ®Google Scholar
• MUCK W, OCHMANN K, ROHDE G: Influence of erythromycin pre- and co-treatment on single-dose pharmacokinetics of the HMG-CoA reductase inhibitor cerivastatin. Eur. j Clin. Pharmacol (1998) 53:469–473.
   PubMed Web of Science ®Google Scholar
• KANTOLA T, KIVISTO KT, NEUVONEN PJ: Effect of itraconazole on cerivastatin pharmacokinetics. Eur. j OM. Pharmacol (1999) 54:851–855.
   PubMed Web of Science ®Google Scholar
• MAZZU AL, LASSETER KC, SHAMBLEN C: Itraconazole alters the pharmacokinetics of atorvastatin to a greater extent than either cerivastatin or pravastatin. Clirr. Pharmacol Ther. (2000) 68:391–400.
   PubMed Web of Science ®Google Scholar
• ALEXANDRIDIS G, PAPPAS G, ELISAF M: Rhabdomyolysis due to combination therapy with cerivastatin and gemfibrozil. Am. J. Med. (2000) 109:261–262.
   PubMed Web of Science ®Google Scholar
• BERMINGHAM RE WHITSITT TB, SMART ML, NOWAK DP, SCALLEY RD: Rhabdomyolysis in a patient receiving the combination of cerivastatin and gemfibrozil. Am. J. Health-System Pharm. (2000) 57:461–464.
   PubMed Web of Science ®Google Scholar
• GARCIA-VALDECASAS-CAMPELO E, GONZALEZ-REIMERS E, LOPEZ-LIROLA A, RODRIGUEZ-RODRIGUEZ E, SANTOLARIO-FERNANDEZ F: Acute rhabdomyolysis associated with cerivastatin therapy. Arch. Intern. Med. (2001) 161:893.
   PubMed Web of Science ®Google Scholar
• GEMICI G, TOPRAK A, OKTAY A: Rhabdomyolysis due to cerivastatin monotherapy. Am. J. Med. (2001) 110:742.
   PubMed Web of Science ®Google Scholar
• GINER V, MUNOZ R, RED ON J: Risperidone and severe cerivastatin induced rhabdomyolysis. J. Intern. Med. (2002) 251:177–178.
   PubMed Web of Science ®Google Scholar
• HENDRIKS F, KOOMAN JP, VAN DER SANDE FM: Massive rhabdomyolysis and life threatening hyperkalemia (sic) in a patient with the combination of cerivastatin and gemfibrozil. Nephrol Dial. Trans. (2001) 16:2418–2419.
   PubMed Web of Science ®Google Scholar
• LAU TK, LEACHMAN R, LUFSCHANOWSKI R: Severe rhabdomyolysis associated with the cerivastatin-gemfibrozil combination therapy - report of a case. Tex. Heart Inst. (2001) 28:142–145.
   PubMed Web of Science ®Google Scholar
• MARIGLIANO N, CASTELLANO I: Cerivastatin-induced rhabdomyolysis (sic) in a patient with diabetic neuropathy. Am. Nephrol (2001) 21:86.
   PubMedGoogle Scholar
• MASTROIANNI CM, D'ETTORRE G, FORCINA G et al.: Rhabdomyolysis after cerivastatin-gemfibrozil therapy in an HIV-infected patient with protease inhibitor-related hyperlipidemia. AIDS (2001) 15:820–821.
   Google Scholar
• MILLIONIS H: Another report of acute rhabdomyolysis following cerivastatin monotherapy. Arch. Intern. Med. (2001) 161:2629–2630.
   Web of Science ®Google Scholar
• MORA C, RODRIGUEZ ML, NAVARRO JF: Cerivastatin-induced rhabdomyolysis in a renal transplant on cyclosporin. Transplantation (2001) 72:551.
   PubMed Web of Science ®Google Scholar
• OLDEMEYER JB, LUND RJ, KOCH M,MEARES AJ, DUNLAY R: Rhabdomyolysis and acute renal failure after changing statin-fibrate combinations. Cardiology (2000) 94:127–128.
   PubMed Web of Science ®Google Scholar
• OZDEMIR 0, BORAN M, GOKCE V, UZUN Y, KOCAK B, KORKMAZ S: A case with severe rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy. Arigiol. Vasc. Dis. (2000) 51:695–697.
   Google Scholar
• POGSON GW, KINDRED LH, CARPER BG: Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy. Am. I Cardiol (1999) 83:1147.
   PubMedGoogle Scholar
• RAVNANM SL, LOCKE C, YEE W, HAASE K: Cerivastatin-induced rhabdomyolysis: 11 case reports. Pharmacotherapy (2002) 22:533–537.
   PubMed Web of Science ®Google Scholar
• SIMPSON S: Case reports of rhabdomyolysis associated with cerivastatin therapy. Arch. Intern. Med. (2001) 161:2630–2631.
   PubMed Web of Science ®Google Scholar
• TOMLINSON B, LAN IW: Combination therapy with cerivastatin and gemfibrozil causing rhabdomyolysis: is the interaction predictable? Am. J. Med. (2001) 110:669–760.
   Google Scholar