Experts in ToxicologyHomeHome
Home PageAbout UsContact UsToxicology SupportProduct SafetyToxicology TopicsOther ServicesDr. Richard A. Parent

Toxicology Litigation Support



Baycol is in a class of cholesterol-lowering drugs called "statins". Several of the "statins" are known to cause muscle toxicity (myotoxicity) but the risk is a lot higher from Baycol than from other drugs in this class. Over a thousand people have died from taking Baycol. The condition which results is rhabdomyolysis which produces elevated myoglobin concentrations in the blood which results in renal failure. The initial symptom of this disease involves elevated liver enzymes, but, as the disease progresses and muscle tissue is wasted, the creatinine phosphokinase level in the blood becomes elevated 10 or more times. This is a clear indicator of muscle damage. A more descriptive narrative on Baycol may be found by clicking on the attached link below.

Selected References

Alexandridis, G., Pappas, G. A. and Elisaf, M. S., Rhabdomyolysis due to combination therapy with cerivastatin and gemfibrozil. American Journal of Medicine, 109(3), 261-262 (2000).  [CTX-030449]

Anonymous, Cerivastatin approval expands HMG-CoA reductase inhibitor choices. American Journal of Health-System Pharmacy, 54(16), 1793 (1997).  [CTX-030450]

Anonymous, Substituting for cerivastatin (Baycol). Medical Letters on Drugs and Therapeutics, 43(1113), 79-80 (2001).  [CTX-030451]

Anonymous, Baycol: take-home messages about medications. Harvard Heart Letters, 12(2), 2-3 (2001).  [CTX-030452]

Axel, D. I., Riessen, R., Runge, H., Viebahn, R. and Karsch, K. R., Effects of cerivastatin on human arterial smooth muscle cell proliferation and migration in transfilter cocultures. Journal of Cardiovascular Pharmacology, 35(4), 619-629 (2000).  [CTX-030453]

Banga, J. D., Myotoxicity and rhabdomyolisis due to statins. Nederlands Tijdschrift Voor Geneeskunde, 145(49), 2371-2376 (2001).  [CTX-030454]

Bauersachs, J., Galuppo, P., Fraccarollo, D., Christ, M. and Ertl, G., Improvement of left ventricular remodeling and function by hydroxymethylglutaryl coenzyme a reductase inhibition with cerivastatin in rats with heart failure after myocardial infarction. Circulation, 104(9), 982-985 (2001).  [CTX-030455]

Beetham, R., Biochemical investigation of suspected rhabdomyolysis. Annals of  Clinical Biochemistry, 37(Pt 5), 581-587 (2000).  [CTX-039949]

Bellosta, S., Bernini, F.,  Ferri, N.,  Quarato, P.,  Canavesi, M.,  Arnaboldi, L.,  Fumagalli, R.,  Paoletti, R. and Corsini, A., Direct vascular effects of HMG-CoA reductase inhibitors. Atherosclerosis, 137(Suppl), S101-S109 (1998).  [CTX-030456]

Beltowski, J., Statins and modulation of oxidative stress. Toxicology Mechanisms and Methods, 15, 61-92 (2005).  [CTX-035454]

Berland, Y., Vacher Coponat, H., Durand, C., Baz M., Laugier, R. and Musso, J. L., Rhabdomyolysis with simvastatin use. Nephron, 57(3), 365-366 (1991).  [CTX-030631]

Bermingham, R. P.,  Whitsitt, T. B.,  Smart, M. L.,  Nowak, D. P. and Scalley, R. D., Rhabdomyolysis in a patient receiving the combination of cerivastatin and gemfibrozil. American Journal of Health- System Pharmacology, 57(5), 461-464 (2000).  [CTX-030457]

Betteridge, D. J., International multicentre comparison of cerivastatin with placebo and simvastatin for the treatment of patients with primary hypercholesterolaemia. International Cerivastatin Study Group. International Journal of Clinical Practice, 53(4), 243-250 (1999).  [CTX-030458]

Bischoff, H.,  Angerbauer, R.,  Boberg, M.,  Petzinna, D.,  Schmidt, D.,  Steinke, W. and Thomas, G., Preclinical review of cerivastatin sodium--a step forward in HMG-CoA reductase inhibition. Atherosclerosis, 139(Suppl 1), S7-S13 (1998).  [CTX-030459]

Bischoff, H. and Heller, A. H., Preclinical and clinical pharmacology of cerivastatin. American Journal of Cardiology, 82(4B), 18J-25J (1998).  [CTX-030460]

Bischoff, H.,  Angerbauer, R.,  Bender, J.,  Bischoff, E.,  Faggiotto, A.,  Petzinna, D.,  Pfitzner, J.,  Porter, M. C.,  Schmidt, D. and Thomas, G., Cerivastatin: pharmacology of a novel synthetic and highly active HMG-CoA reductase inhibitor. Atherosclerosis, 135(1), 119-130 (1997).  [CTX-030461]

Black, D. M., A General Assessment of the Safety of HMG CoA Reductase Inhibitors (Statins). Current Atherosclerosis Reports, 4(1), 34-41 (2002).  [CTX-030462]

Boberg, M., Angerbauer, R.,  Kanhai, W. K.,  Karl, W.,  Kern, A.,  Radtke, M. and Steinke, W., Biotransformation of cerivastatin in mice, rats, and dogs in vivo. Drug Metabolism and Disposition, 26(7), 640-652 (1998).  [CTX-030463]

Boberg M.,  Angerbauer, R.,  Fey, P.,  Kanhai, W. K.,  Karl, W., Kern, A., Ploschke, J. and Radtke, M., Metabolism of cerivastatin by human liver microsomes in vitro. Characterization of primary metabolic pathways and of cytochrome P450 isozymes involved. Drug Metabolism and Disposition, 25(3), 321-331 (1997).  [CTX-030464]

Bosch Rovira, T., Llompart Pou, J. A. and Forteza-Rey, J., Rhabdomyolysis associated with combined treatment of cerivastatin and gemfibrozil. Revista Clinica Espanola, 201(12), 731-732 (2001).  [CTX-030465]

Breuer, H. W., Hypertriglyceridemia: a review of clinical relevance and treatment options: focus on cerivastatin. Current Medical Research and Opinion, 17(1), 60-73 (2001).  [CTX-030466]

Brinton, E. A., Newer HMG-CoA reductase inhibitor (statin) therapies. Clinical Cardiology, 24(7), II-10-13 (2001).  [CTX-030467]

Bruno-Joyce, J., Dugas, J. M. and MacCausland, O. E., Cerivastatin and gemfibrozil-associated rhabdomyolysis. Annals of  Pharmacotherapy, 35(9), 1016-1019 (2001).  [CTX-030468]

Charatan, F., Bayer decides to withdraw cholesterol lowering drug. British Medical Journal, 323(7309), 359 (2001).  [CTX-030469]

Cheng-Lai, A., Cerivastatin. Heart Disease, 2(1), 93-99 (2000).  [CTX-030470]

Chong, P. H., Seeger, J. D. and Franklin, C., Clinically relevant differences between the statins: implications for therapeutic selection. American Journal of Medicine, 111(5), 390-400 (2001).  [CTX-030471]

Cohen, L. H., van Leeuwen, R. E., van Thiel, G. C.,  van Pelt, J. F. and Yap, S. H., Equally potent inhibitors of cholesterol synthesis in human hepatocytes have distinguishable effects on different cytochrome P450 enzymes. Biopharmaceutics and Drug Disposition, 21(9), 353-364 (2000).  [CTX-030472]

Corsini, A., Arnaboldi, L., Raiteri, M., Quarato, P., Faggiotto, A., Paoletti, R. and Fumagalli, R., Effect of the new HMG-CoA reductase inhibitor cerivastatin (BAYW 6228)on migration, proliferation and cholesterol synthesis in arterial myocytes. Pharmacological Research, 33(1), 55-61 (1996).  [CTX-030473]

Corsini, A., Bellosta, S., Baetta, R., Fumagalli, R., Paoletti, R. and Bernini, F., New insights into the pharmacodynamic and pharmacokinetic properties of statins. Pharmacology and Therapeutics, 84(3), 413-428 (1999). [CTX-030474]

Dansette, P. M., Jaoen, M. and Pons, C., HMG-CoA reductase activity in human liver microsomes: comparative inhibition by statins. Experimental Toxicology and Pathology, 52(2), 145-148 (2000).  [CTX-030475]

Davidson, M. H., Treatment of the elderly with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors: focus on drug interactions. Journal of Cardiovascular Pharmacology and Therapeutics, 6(3), 219-229 (2001).  [CTX-030476]

Davidson, M. H., Statin trials in progress: unanswered questions. Current Atherosclerosis Reports, 3(1), 9-13 (2001).  [CTX-030477]

Davignon, J.,  Hanefeld, M.,  Nakaya, N.,  Hunninghake, D. B.,  Insull, Jr., W. and Ose, L., Clinical efficacy and safety of cerivastatin: summary of pivotal phase Iib/III studies. American Journal of Cardiology, 82(4B), 32J-39J (1998).  [CTX-030478]

Dayer-Berenson, L., Rhabdomyolysis: a comprehensive guide. American Nephrology Nurses' Association Journal, 21(1), 15-18; quiz 19-20 (1994).  [CTX-030633]

de Arriba Mendez, J. J., Gomez Merino, E., Saez Barcelona, J. A. and Saez Mendez, L., Severe rhabdomyolysis associated with cerivastatin and gemfibrozil. Medical Clinics (Barcelona), 117(7), 278-279 (2001).  [CTX-030479]

De Luis, D. A., Romero, E., Aller, R. and Izaola, O., Effect of cerivastatin on serum cholesterol levels in patients with type 2 diabetes mellitus. Clinical Nutrition, 19(5), 367-370 (2000).  [CTX-030480]

Dechend, R.,  Fiebeler, A.,  Park, J. K.,  Muller, D. N.,  Theuer, J.,  Mervaala, E.,  Bieringer, M.,  Gulba, D., Dietz, R.,  Luft, F. C., and Haller, H., Amelioration of angiotensin II-induced cardiac injury by a 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor. Circulation, 104(5), 576-581 (2001).  [CTX-030481]

Dechend, R., Fiebler, A., Lindschau, C., Bischoff, H., Muller, D., Park, J. K., Dietz, R., Haller, H. and Luft, F. C., Modulating angiotensin II-induced inflammation by HMG Co-A reductase inhibition. American Journal of Hypertension, 14(6 Pt 2), 55S-61S (2001).  [CTX-030482]

Dujovne, C. A., Knopp, R., Kwiterovich, P., Hunninghake, D., McBride, T. A. and Poland, M., Randomized comparison of the efficacy and safety of cerivastatin and pravastatin in 1,030 hypercholesterolemic patients. The Cerivastatin Study Group. Mayo Clinic Proceedings, 75(11), 1124-1132 (2000).  [CTX-030483]

Farmer, J. A., Learning from the cerivastatin experience. Lancet, 358(9291), 1383-1385 (2001).  [CTX-030484]

Farmer, J. A. and Torre-Amione, G., Comparative tolerability of the HMG-CoA reductase inhibitors. Drug Safety, 23(3), 197-213 (2000).  [CTX-030485]

Farnier, M., Cerivastatin in the treatment of mixed hyperlipidemia: the RIGHT study. The Cerivastatin Study Group. Cerivastatin Gemfibrozil Hyperlipidemia Treatment. American Journal of Cardiology, 82(4B), 47J-51J (1998).  [CTX-030486]

Federman, D. G., Hussain, F. and Walters, A. B., Fatal rhabdomyolysis caused by lipid-lowering therapy. Southern Medical Journal, 94(10), 1023-1026 (2001).  [CTX-039948]

Fleck, F., Bayer faces Swiss criminal probe over cerivastatin. British Medical Journal, 324(7330), 130 (2002).  [CTX-030487]

Furberg, C. D. and Pitt, B., Withdrawal of cerivastatin from the world market. Current Controlled Trials in Cardiovascular Medicine, 2(5), 205-207 (2001).  [CTX-030488]

Gabay, M. and Lodolce, A., Other reports of cerivastatin-induced rhabdomyolysis. Archives of Internal Medicine, 161(21), 2629 (2001).  [CTX-030489]

Garcia, I., Errasti, P., Lavilla, F. J., Ballester, B., Manrique, J., Rossich, E. and Purroy, A., Effects of cerivastatin in dyslipemia and other cardiovascular risk factors after renal transplantation. Transplantation Proceedings, 34(1), 401-402 (2002).  [CTX-030490]

Garcia-Valdecasas-Campelo, E., Gonzalez-Reimers, E., Lopez-Lirola, A., Rodriguez-Rodriguez, E. and Santolaria-Fernandez, F., Acute rhabdomyolysis associated with cerivastatin therapy. Archives of Internal Medicine, 161(6), 893 (2001).  [CTX-030491]

Garnett, W. R., Interactions with hydroxymethylglutaryl-coenzyme A reductase inhibitors. American Journal of Health-System Pharmacy, 52(15), 1639-1645 (1995).  [CTX-030630]

Gemici, G., Toprak, A. and Oktay, A., Rhabdomyolysis due to cerivastatin monotherapy. American Journal of Medicine, 110(9), 742 (2001).  [CTX-030492]

Giner, V.,  Munoz, R. and Redon, J., Risperidone and severe cerivastatin-induced rhabdomyolysis. Journal of Internal Medicine, 251(2), 177-178 (2002).  [CTX-030493]

Griffin, J. P., The withdrawal of Baycol (cerivastatin). Adverse Drug Reactions and Toxicological Reviews, 20(4), 177-180 (2001).  [CTX-030494]

Guyton, J. R., Dujovne, C. A. and Illingworth D. R., Dual hepatic metabolism of cerivastatin--clarifications. American Journal Cardiology, 84(4), 497 (1999).  [CTX-030495]

Hamilton-Craig, I., Statin-associated myopathy. Medical Journal of Australia, 175(9), 486-489 (2001).  [CTX-030496]

Hanefeld, M., Deslypere, J. P., Ose, L., Durrington, P. N., Farnier, M. and Schmage, N., Efficacy and safety of 300 micrograms and 400 micrograms cerivastatin once daily in patients with primary hypercholesterolaemia: a multicentre, randomized, double-blind, placebo-controlled study. Journal of International Medical Research, 27(3), 115-129 (1999).  [CTX-030497]

Hendriks, F., Kooman, J. P. and van der Sande, F. M., Massive rhabdomyolysis and life threatening hyperkalaemia in a patient with the combination of cerivastatin and gemfibrozil. Nephrology Dialysis Transplantion, 16(12), 2418-2419 (2001).  [CTX-030498]

Herman, R. J., Drug interactions and the statins. Canadian Medical Association Journal, 161(10), 1281-1286 (1999).  [CTX-030626]

Hodel, C., Myopathy and rhabdomyolysis with lipid-lowering drugs. Toxicology Letters, 128(1-3), 159-168 (2002).  [CTX-030499]

Hodgson, J., Bayer lapse exposes pharma's vulnerability. National Biotechnology, 19(10), 897-898 (2001).  [CTX-030500]

Horimoto, H., Nakai, Y., Nakahara, K., Mieno, S. and Sasaki, S., HMG-COA reductase inhibitor cerivastatin prolonged rat cardiac allograft survival by blocking intercellular signals. Journal of Heart and Lung Transplantion, 20(2), 227 (2001).  [CTX-030501]

Hunninghake, D., Insull, W., Knopp, R., Davidson, M., Lohrbauer, L., Jones, P. and Kafonek, S., Comparison of the efficacy of atorvastatin versus cerivastatin in primary hypercholesterolemia. American Journal of Cardiology, 88(6), 635-639 (2001).  [CTX-030503]

Hunninghake, D. B., Clinical efficacy of cerivastatin: phase IIa dose-ranging and dose-scheduling studies. American Journal of Cardiology, 82(4B), 26J-31J (1998).  [CTX-030502]

Ichiki, T., Takeda, K., Tokunou, T., Iino, N., Egashira, K., Shimokawa, H., Hirano, K., Kanaide, H. and Takeshita, A., Downregulation of angiotensin II type 1 receptor by hydrophobic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors in vascular smooth muscle cells. Arteriosclerosis Thrombosis and Vascular Biology, 21(12), 1896-1901 (2001).  [CTX-030504]

Igel, M., Sudhop, T. and von Bergmann, K., Metabolism and drug interactions of 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins). European Journal of Clinical Pharmacology, 57(5), 357-364 (2001).  [CTX-030505]

Imbs, J. L., Unexpected consequences of an expected adverse effect of cerivastatine. Revue de Medecine Interne, 23(1), 1-3 (2002).  [CTX-030506]

Insull, Jr., W., Isaacsohn, J., Kwiterovich, P., Ra, P., Brazg, R., Dujovne, C., Shan, M., Shugrue-Crowley, E., Ripa, S. and Tota, R., Efficacy and safety of cerivastatin 0.8 mg in patients with hypercholesterolaemia: the pivotal placebo-controlled clinical trial. Cerivastatin Study Group. Journal of International Medical Research, 28(2), 47-68 (2000).  [CTX-030507]

Isaacsohn, J., Insull, Jr., W., Stein, E., Kwiterovich, P., Patrick, M. A., Brazg, R., Dujovne, C. A., Shan, M., Shugrue-Crowley, E., Ripa, S. and Tota, R., Long-term efficacy and safety of cerivastatin 0.8 mg in patients with primary hypercholesterolemia. Clinical Cardiology, 24(9 Suppl), IV1-9 (2001).  [CTX-030508]

Isaacsohn, J., Zinny, M., Mazzu, A., Lettieri, J. and Heller, A. H., Influence of gender on the pharmacokinetics, safety, and tolerability of cerivastatin in healthy adults. European Journal of Clinical Pharmacology, 56(12), 897-903 (2001).  [CTX-030509]

Ishigami, M., Honda, T., Takasaki, W., Ikeda, T., Komai, T., Ito, K. and Sugiyama, Y., A comparison of the effects of 3-hydroxy-3-methylglutaryl-coenzyme a (HMG-CoA) reductase inhibitors on the CYP3A4-dependent oxidation of mexazolam in vitro. Drug Metabolism and Disposition, 29(3), 282-288 (2001).  [CTX-030510]

Jemal, M., Rao, S., Salahudeen, I., Chen, B. C. and Kates, R., Quantitation of cerivastatin and its seven acid and lactone biotransformation products in human serum by liquid chromatography-electrospray tandem mass spectrometry. Journal of Chromatography [B] Biomedical Science Applications, 736(1-2), 19-41 (1999).  [CTX-030511]

Keane, W. F., Brenner, B. M., Mazzu, A. and Agro, A., The CHORUS (Cerivastatin in Heart Outcomes in Renal Disease: Understanding  Survival) protocol:  a double-blind . placebo-controlled trial in patients with ESRD. American Jounral of Kidney Disease, 37(1 Suppl 2), S48-S53 (2001).  [CTX-030512]

Lau, T. K., Leachman, D. R. and Lufschanowski, R., Severe rhabdomyolysis associated with the cerivastin-gemfibrozil combination therapy: report of a case. Texas Heart Institute Journal, 28(2), 142-145 (2001).  [CTX-030513]

Lee, A. J. and Maddix, D. S., Rhabdomyolysis secondary to a drug interaction between simvastatin and clarithromycin. Annals of Pharmacotherapy, 35(1), 26-31 (2001).  [CTX-030514]

Leiter, L. A. and Hanna, K., Efficacy and safety of cerivastatin in primary hypercholesterolemia: a long term comparative titration study with simvastatin. Canadian Jounral of Cardiology, 15(5), 545-555 (1999).  [CTX-030515]

Mabuchi, H., Koizumi, J. and Kajinami, K., Clinical efficacy and safety of cerivastatin in the treatment of heterozygous familial hypercholesterolemia. American Journal of Cardiology, 82(4B), 52J-55J (1998).  [CTX-030516]

Marigliano, N., Castellano, I., Sanchez, O. and Covarsi, A., Cerivastatin-induced rhabdomyolisis in a patient with diabetic nephropathy. American Journal of Nephrology, 21(1), 86 (2001).  [CTX-030517]

Maron, D. J., Fazio, S. and Linton, M. F., Current perspectives on statins. Circulation, 101(2), 207-213 (2000).  [CTX-030629]

Mastroianni, C. M., Dettorre, G., Forcina, G., Liuchtner, M., Corpolongo, A., Coletta, S., et al., Rhabdomyolysis after cerivastatin-gemfibrozil therapy in an HIV-infected patient with protease inhibitor-related hyperlipidemia. AIDS, 15, 820-821 (2001).  [CTX-030617]

Mazzu, A., Lettieri, J., Kaiser, L., Mullican, W. and Heller, A. H., Influence of age  on the safety, tolerability, and pharmacokinetics of the novel HMG-CoA reductase inhibitor cerivastatin in healthy male volunteers. Journal of Clinical Pharmacology, 38(8), 715-719 (1998).  [CTX-030518]

Mazzu, A. L., Lettieri, J. T., Kelly, E., Vargas, R., Marbury, T., Liu, M. C. and Sundaresan, P., Influence of renal function on the pharmacokinetics of cerivastatin in normocholesterolemic adults. European Journal of Clinical Pharmacology, 56(1), 69-74 (2000).  [CTX-030519]

McClellan, K. J., Wiseman, L. R. and McTavish, D., Cerivastatin. Drugs, 55(3), 415-420 (1998).  [CTX-030520]

McPherson, R., Hanna, K., Agro, A. and Braeken, A., Cerivastatin versus branded pravastatin in the treatment of primary hypercholesterolemia in primary care practice in Canada: a one-year, open-label, randomized, comparative study of efficacy, safety, and cost-effectiveness. Clinical Therapeutics, 23(9), 1492-1507 (2001).  [CTX-030521]

Milionis, H. J., Tsapoga, T. G. and Elisaf, M. S., Another report of acute rhabdomyolysis following cerivastatin monotherapy. Archives of Internal Medicine, 161(21), 2629-2630 (2001).  [CTX-030522]

Mora, C., Rodriguez, M. L. and Navarro, J. F., Cerivastatin-induced rhabdomyolysis in a renal transplant on cyclosporin. Transplantation, 72(3), 551 (2001).  [CTX-030523]

Muck, W.,  Mai, I., Fritsche, L., Ochmann, K., Rohde, G., Unger, S., Johne, A., Bauer, S., Budde, K., Roots, I., Neumayer, H. H. and Kuhlmann, J., Increase in cerivastatin systemic exposure after single and multiple dosing in cyclosporine-treated kidney transplant recipients. Clinical Pharmacology and Therapeutics, 65(3), 251-261 (1999).  [CTX-030524]

Muck, W., Ochmann, K., Mazzu, A. and Lettieri, J., Biopharmaceutical profile of cerivastatin: a novel HMG-CoA reductase inhibitor. Journal of International Medical Research, 27(3), 107-114 (1999).  [CTX-030525]

Muck, W., Ritter, W., Ochmann, K., Unger, S., Ahr, G., Wingender, W. and Kuhlmann, J., Absolute and relative bioavailability of the HMG-CoA reductase inhibitor cerivastatin. International Journal of Clinical Pharmacology and  Therapeutics, 35(6), 255-260 (1997).  [CTX-030526]

Muck, W., Unger, S., Kawano, K. and Ahr, G., Inter-ethnic comparisons of the pharmacokinetics of the HMG-CoA reductase inhibitor cerivastatin. British Journal of Clinical Pharmacology, 45(6), 583-590 (1998).  [CTX-030527]

Muck, W., Clinical pharmacokinetics of cerivastatin. Clinical Pharmacokinetics, 39(2), 99-116 (2000).  [CTX-030528]

Nakamura, T., Ushiyama, C., Hirokawa, K., Osada, S., Shimada, N. and Koide, H., Effect of cerivastatin on urinary albumin excretion and plasma endothelin-1 concentrations in type 2 diabetes patients with microalbuminuria and dyslipidemia. American Journal of Nephrology, 21(6), 449-454 (2001).  [CTX-030529]

Nakaya, N., Cerivastatin. Japanese Journal of Clinical Medicine, 59(Suppl 3), 592-597 (2001).  [CTX-030530]

Negre-Aminou, P., van Vliet, A. K., van Erck, M., van Thiel, G. C., van Leeuwen, R. E. and Cohen, L. H., Inhibition of proliferation of human smooth muscle cells by various HMG-CoA reductase inhibitors; comparison with other human cell types. Biochimica et Biophysica Acta, 1345(3), 259-268 (1997).  [CTX-030531]

Ni, W., Egashira, K., Kataoka, C., Kitamoto, S., Koyanagi, M., Inoue, S. and Takeshita, A., Antiinflammatory and antiarteriosclerotic actions of HMG-CoA reductase inhibitors in a rat model of chronic inhibition of nitric oxide synthesis. Circulation Research, 89(5), 415-421 (2001).  [CTX-030532]

Omar, M. A. and Wilson, J. P., FDA adverse event reports on statin-associated rhabdomyolysis. Annals of Pharmacotherapy, 36(2), 288-295 (2002).  [CTX-030533]

Omar, M. A., Wilson, J. P. and Cox, T. S., Rhabdomyolysis and HMG-CoA reductase inhibitors. Annals of Pharmacotherapy, 35(9), 1096-1107 (2001).  [CTX-030634]

Ose, L., Luurila, O., Eriksson, J., Olsson, A., Lithell, H. and Widgren, B., Cerivastatin gender effect: sub-analyses of results from a multinational, randomised, double-blind study. Cerivastatin Study Group. Current Medical Research and Opinion, 16(2), 80-87 (2000).  [CTX-030534]

Ose, L., Luurila, O., Eriksson, J., Olsson, A., Lithell, H. and Widgren, B., Efficacy and safety of cerivastatin, 0.2 mg and 0.4 mg, in patients with primary hypercholesterolaemia: a multinational, randomised, double-blind study. Cerivastatin Study Group. Current Medical Research and Opinion, 15(3), 228-240 (1999).  [CTX-030535]

Ozdemir, O., Boran, M., Gokce, V., Uzun, Y., Kocak, B. and Korkmaz, S., A case with severe rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy--a case report. Angiology, 51(8), 695-697 (2000).  [CTX-030536]

Park, J. K., Muller, D. N., Mervaala, E. M., Dechend, R., Fiebeler, A., Schmidt, F., Bieringer, M., Schafer, O., Lindschau, C., Schneider, W., Ganten, D., Luft, F. C. and Haller, H., Cerivastatin prevents angiotensin II-induced renal injury independent of blood pressure- and cholesterol-lowering effects. Kidney International, 58(4), 1420-1430 (2000).  [CTX-030537]

Pauletto, P., Puato, M., Faggin, E. and Sartore, S., Low-dose cerivastatin inhibits spontaneous atherogenesis in heterozygous watanabe hyper lipidemic rabbits. Journal of Vascular Research, 37(3), 189-194 (2000).  [CTX-030538]

Perreault, S., Levinton, C. and Le Lorier, J., Efficacy and cost of HMG-CoA reductase inhibitors in the treatment of patients with primary hyperlipidemia. Canadian Journal of Clinical Pharmacology, 7(3), 144-154 (2000).  [CTX-030539]

Pierce, L. R., Wysowski, D. K. and Gross, T. P., Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. Journal of the American Medical Association, 264(1), 71-75 (1990).  [CTX-030635]

Plosker, G. L., Dunn, C. I. and Figgitt, D. P., Cerivastatin: a review of its pharmacological properties and therapeutic efficacy in the management of hypercholesterolaemia. Drugs, 60(5), 1179-206 (2000).  [CTX-030540]

Poels, P. J. and Gabreels, F. J., Rhabdomyolysis: a review of the literature. Clinical Neurology and Neurosurgery, 95(3), 175-192 (1993).  [CTX-030632]

Pogson, G. W., Kindred, L. H. and Carper, B. G., Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy. American Journal of Cardiology, 83(7), 1146 (1999).  [CTX-030541]

Prieto, J. C., Safety profile of statins. Revista Medica De Chile, 129(11), 1237-1240 (2001).  [CTX-030542]

Ravnan, S. L., Locke, C., Yee, W. P. and Haase, K., Cerivastatin-induced rhabdomyolysis: 11 case reports. Pharmacotherapy, 22(4), 533-537 (2002).  [CTX-030543]

Ridker, P. M., Rifai, N. and Lowenthal, S. P., Rapid reduction in C-reactive protein with cerivastatin among 785 patients with primary hypercholesterolemia. Circulation, 103(9), 1191-1193 (2001).  [CTX-030544]

Roca, B., Calvo, B. and Monferrer, R., Severe rhabdomyolysis and cerivastatin-gemfibrozil combination therapy. Annals of Pharmacotherapy, 36(4), 730-731 (2002).  [CTX-030545]

Rodriguez, M. L., Mora, C. and Navarro, J. F., Cerivastatin-induced rhabdomyolysis. Annals of Internal Medicine, 132(7), 598 (2000).  [CTX-030546]

Sasaki, J., Arakawa, K., Yamamoto, K., Kobori, S., Ageta, M. and Kono, S., A comparative long-term trial of sodium cerivastatin, a new HMG-CoA reductase inhibitor, in patients presenting with primary hypercholesterolemia. Revue de Medecine Interne, 20(Suppl 3), 393s-398s (1999).  [CTX-030547]

Sasaki, J., Arakawa, K., Yamamoto, K., Kobori, S., Ageta, M. and Kono, S., A long-term comparative trial of cerivastatin sodium, a new HMG-CoA reductase inhibitor, in patients with primary hypercholesterolemia. Clinical Therapeutics, 20(3), 539-548 (1998).  [CTX-030548]

Saunders, E., Ferdinand, K., Yellen, L. G., Tonkon, M. J., Krug-Gourley, S. and Poland, M., Efficacy and safety of cerivastatin and pravastatin in the treatment of primary hypercholesterolemia. Journal of the National Medical Association, 92(7), 319-326 (2000).  [CTX-030549]

Schwandt, P., After recall of cerivastatin. How safe are statins in reality? (interview by Dr. Dirk Einecke). MMW-Fortschritte Der Medizin, 143(33-34), 12 (2001).  [CTX-030550]

Shek, A. and Ferrill, M. J., Statin-fibrate combination therapy. Annals of Pharmacotherapy, 35(7-8), 908-917 (2001).  [CTX-030551]

Shiomi, M. and Ito, T., Effect of cerivastatin sodium, a new inhibitor of HMG-CoA reductase, on plasma lipid levels, progression of atherosclerosis, and the lesional composition in the plaques of WHHL rabbits. British Journal of Pharmacology, 126(4), 961-968 (1999).  [CTX-030552]

Sica, D. A. and Gehr, T. W., 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors and rhabdomyolysis: considerations in the renal failure patient. Current Opinion in Nephrology and Hypertension, 11(2), 123-133 (2002).  [CTX-030553 . CTX-030555]

Sica, D. A. and Gehr, T. W., Rhabdomyolysis and statin therapy: relevance to the elderly. American Journal of Geriatric Cardiology, 11(1), 48-55 (2002).  [CTX-030554]

Simpson, S., Case reports of rhabdomyolysis associated with cerivastatin therapy. Archives of Internal Medicine, 161(21), 2630-2631 (2001).  [CTX-030556]

Solov'eva, E. Iu., Rozhkova, T. A., Tvorogova, M. G. and Kukharchuk, V. V., Cerivastatin-a new synthetic 3-hydroxy-3-methylglutaryl (HMG) inhibitor: effect of 0,2 mg dose in patients with primary hyperlipidemias. Terapevticheskii Arkhiv, 71(8), 30-34 (1999).  [CTX-030557]

SoRelle, R., Baycol withdrawn from market. Circulation, 104(8), E9015-E9016 (2001).  [CTX-030558]

Staffa, J. A., Chang, J. and Green, L., Cerivastatin and reports of fatal rhabdomyolysis. New England Journal of Medicine, 346(7), 539-540 (2002).  [CTX-030559]

Stalenhoef, A. F., Mol, M. J. and Stuyt, P. M., Efficacy and tolerability of simvastatin (MK-733). American Journal of Medicine, 87(4A), 39S-43S (1989).  [CTX-030627]

Stein, E., Cerivastatin in primary hyperlipidemia: a multicenter analysis of efficacy and safety. American Journal of Cardiology, 82(4B), 40J-46J (1998).  [CTX-030560]

Stein, E., Cerivastatin in primary hyperlipidemia--a multicenter analysis of efficacy and safety. Atherosclerosis, 139(Supp[l), Suppl 1 (1998).  [CTX-030561]

Stein, E., Sprecher, D., Allenby, K. S., Tosiello, R. L., Whalen, E. and Ripa, S. R., Cerivastatin, a New Potent Synthetic HMG Co-A Reductase Inhibitor: Effect of 0.2 mg Daily in Subjects With Primary Hypercholesterolemia. Journal of Cardiovascular Pharmacology and Therpeutics, 2(1), 7-16 (1997).  [CTX-030562]

Stein, E., Isaacsohn J . Stoltz R . Mazzu A . Liu MC . Lane C . Heller AH,, Pharmacodynamics, safety, tolerability, and pharmacokinetics of the 0.8-mg dose of cerivastatin in patients with primary hypercholesterolemia. <>AmericanJ Cardiol, 83(10), 1433-1436 (1999).  [CTX-030563]

Suzuki, H., Yamazaki, H., Aoki, T., Tamaki, T., Sato, F., Kitahara, M. and Saito, Y., Hypolipidemic effect of NK-104 and other 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors in guinea pigs. Arzneimittelforschung, 51(1), 38-45 (2001).  [CTX-030564]

Tazuma, S., Yamashita, G., Ochi, H., Miura, H., Kajihara, T., Hattori, Y., Miyake, H., Nishioka, T., Hyogo, H., Sunami, Y., Yasumiba, S. and Kajiyama, G., Effects of cerivastatin sodium, a new HMG-CoA reductase inhibitor, on biliary lipid metabolism in patients with hypercholesterolemia. Clinical Therapeutics, 20(3), 477-485 (1998).  [CTX-030565]

Teupser, D., Bruegel, M., Stein, O., Stein, Y. and Thiery, J., HMG-CoA reductase inhibitors reduce adhesion of human monocytes to endothelial cells. Biochemical and Biophysical Research Commununications, 289(4), 838-844 (2001).  [CTX-030566]

Thompson, C. A., Cerivastatin withdrawn from market. American Journal of Health-System Pharmacy, 58(18), 1685 (2001).  [CTX-030567]

Tikkanen, M. J., Cerivastatin: the low-dose HMG-COA reductase inhibitor. Expert Opinion on Investigational Drugs, 9(1), 161-166 (2000).  [CTX-030568]

Tomita, N., Morishita, R. and Ogihara, T., Ongoing clinical trials by vascular statin, cerivastatin. Japanese Journal of Clinical Medicine, 59(Suppl 3), 477-482 (2001).  [CTX-030569]

Tomlinson, B. and Lan, I. W., Combination therapy with cerivastatin and gemfibrozil causing rhabdomyolysis: is the interaction predictable? American Journal of Medicine, 110(8), 669-670 (2001).  [CTX-030570]

Tuffs, A., Bayer faces potential fine over cholesterol lowering drug. British Medical Journal,
323(7310), 415 (2001).  [CTX-030571]

Vasconez-Espinosa, F., Gomez Rodriguez, N., Martin Joven, A. and Posada Garcia, F. J., Rhabdomyolysis complicated with acute renal insufficiency in a patient treated with gemfibrozil and cerivastatin. Revista Clinica Espanola, 201(4), 228-229 (2001).  [CTX-030572]

Vera, M., Pou, M., Botey, A. and Cases, A., Massive rhabdomyolysis associated with the use of cerivastatin monotherapy. Nefrologia, 21(6), 613-614 (2001).  [CTX-030573]

Vincent, L., Chen, W., Hong, L., Mirshahi, F., Mishal, Z., Mirshahi-Khorassani, T., Vannier, J. P., Soria, J. and Soria, C., Inhibition of endothelial cell migration by cerivastatin, an HMG-CoA reductase inhibitor: contribution to its anti-angiogenic effect. Federation of the Experimental Biology Society Letters, 495(3), 159-166 (2001).  [CTX-030574]

Vincent, L., Soria, C., Mirshahi, F., Opolon, P., Mishal, Z., Vannier, J. P., Soria, J. and Hong, L., Cerivastatin, an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme a reductase, inhibits endothelial cell proliferation induced by angiogenic factors in vitro and angiogenesis in in vivo models. Arteriosclerosis Thrombosis and Vascular Biology, 22(4), 623-629 (2002).  [CTX-030575]

von Keutz, E. and Schluter, G., Preclinical safety evaluation of cerivastatin, a novel HMG-CoA reductase inhibitor. American Journal of Cardiology, 82(4B), 11J-17J (1998). [CTX-030576]

Vormfelde, S. V., Muck, W., Freudenthaler, S. M., Heyen, P., Schmage, N., Kuhlmann, J., Muller, G. A., Gundert-Remy, U. M. and Gleiter, C. H., Pharmacokinetics of cerivastatin in renal impairment are predicted by low serum albumin concentration rather than by low creatinine clearance. Journal of Clinical Pharmacology, 39(2), 147-154 (1999).  [CTX-030577]

Vormfelde, S. V., Safety of statins (hydroxymethyl glutaryl coenzyme a reductase inhibitors): different mechanisms of metabolism and drug transport may have clinical relevance. Archives of Internal Medicine, 161(7), 1012-1013 (2001).  [CTX-030578]

White, C. M., Pharmacological effects of HMG CoA reductase inhibitors other than lipoprotein modulation. Journal of Clinical Pharmacology, 39(2), 111-118 (1999).  [CTX-030579]

Wierzbicki, A. S., Synthetic statins: more data on newer lipid-lowering agents. Current Medical Research and Opinion, 17(1), 74-77 (2001).  [CTX-030580]

Wiesbauer, F., Kaun, C., Zorn, G., Maurer, G., Huber, K. and Wojta, J., HMG CoA reductase inhibitors affect the fibrinolytic system of human vascular cells in vitro: a comparative study using different statins. British Journal of Pharmacology, 135(1), 284-292 (2002).  [CTX-030581]

Wooltorton, E., Bayer pulls cerivastatin (Baycol) from market. Canadian Medical Association Journal, 165(5), 632 (2001).  [CTX-030582]

Yang, Z., Kozai, T., van der Loo, B., Viswambharan, H., Lachat, M., Turina, M. I., Malinski, T. and Luscher, T. F., HMG-CoA reductase inhibition improves endothelial cell function and inhibits smooth muscle cell proliferation in human saphenous veins. Journal of the American College of Cardiology, 36(5), 1691-1697 (2000). [CTX-030583]

Yasunobu, Y., Hayashi, K., Shingu, T., Nomura, K., Ohkura, Y., Tanaka, K., Kuga, Y., Nomura, S., Ohtani, H., Nishimura, T., Matsuura, H. and Kajiyama, G., Reduction of plasma cholesterol levels and induction of hepatic LDL receptor by cerivastatin sodium (CAS 143201-11-0, BAY w 6228), a new inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, in dogs. Cardiovascular Drugs and Therapy, 11(4), 567-574 (1997).  [CTX-030584]

Ziegler, O. and Drouin, P., Safety, tolerability, and efficacy of simvastatin and fenofibrate--a multicenter study. Simvastatin-Fenofibrate Study Group. Cardiology, 77(Suppl 4), 50-57 (1990).  [CTX-030628]

In This Section

Causation Reports

Toxicology Notes and Literature

Toxicology Litigation Support