Cerivastatin in primary hyperlipidemia - A multicenter analysis of efficacy and safety

Atherosclerosis

Volumn 139, Issue SUPPL. 1, 1998, Pages 15-22

  Stein, Evan ^a  

^a Pharmaceutical Product Development   (United States)

Author keywords

Clinical efficacy; Hyperlipidemia; Low density cholesterol

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CERIVASTATIN; CHOLESTEROL; CREATINE KINASE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LIPID; LIVER ENZYME; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; PLACEBO; SIMVASTATIN; TRIACYLGLYCEROL;

ADULT; AGED; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLU LIKE SYNDROME; GASTROINTESTINAL TOXICITY; HEADACHE; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; MYOPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE;

EID: 0031671753     PISSN: 00219150     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0021-9150(98)00189-0     Document Type: Conference Paper

References (25)

1. Blum CB, Levy RI. Current therapy for hypercholesterolemia. J Am Med Assoc 1989;261:3582-7.
2. Angerbauer R, Bischoff H, Steinke W, Ritter W. BAY w 6228: hypolipidemic HMG-CoA reductase inhibitor. Drugs Fut 1994;19:537-41.
3. Bischoff H, Angerbauer R, Bender J, Bischoff E, Faggiotto A, Petzinna D, et al. Cerivastatin: pharmacology of a novel synthetic and high active HMG-CoA reductase inhibitor. Atherosclerosis 1997;135:119-30.
4. Frey R, Mazzu AL, Ritter W, Heller AH, Kuhlmann J. Safety and tolerability of rivastatin, a novel HMG-CoA reductase inhibitor, in phase-I single dose studies, (Abstract). Naunyn Schmiedebergs Arch Pharmacol 1993;347:30.
5. Mazzu AL, Lettieri J, Kaiser L, Frey R, Heller AH. Ascending multiple dose safety, tolerability and pharmacodynamics of rivastatin in humans, (Abstract no. PIII-95). Clin Pharmacol Ther 1993;53:230.
6. Mück W, Ritter W, Dietrich H, Frey R, Kuhlmann J. Influence of the antacid Maalox and the H2-antagonist cimetidine on the pharmacokinetics of cerivastatin. Int J Clin Pharmacol Ther 1997;35:621-4.
7. Mück W, Ritter W, Frey R, Wetzelsberger N, Lucker PW, Kulhmann J. Influence of cholestyramine on the pharmacokinetics of cerivastatin. Int J Clin Pharmacol Ther 1997;35:250-4.
8. Lettieri J, Krol G, Mazzu AL, Fiebach M, Heller AH. Lack of pharmacokinetic interaction between cerivastatin, a new HMG-CoA reductase inhibitor, and digoxin. Atherosclerosis 1997;130:S29-A109.
9. Schall R, Müller FO, Hundt HKL, Ritter W, Duursema L, Groenewoud G, et al. No pharmacokinetic or pharmacodynamic interaction between rivastatin and warfarin. J Clin Pharmacol 1995;35:306-13.
10. Mück W, Ochmann K, Unger S, Kuhlmann J. Influence of erythromycin pre-and co-treatment on single-dose pharmacokinetics of the HMG-CoA reductase inhibitor cerivastatin. Clin Pharmacol Ther 1998;53:469-73.
11. Lettieri J, Krol G, Mazzu AL, Shah A, Falk R, Beck C. Effect of age and gender on the steady-state pharmacokinetics of rivastatin, (Abstract no. PPDM 8159). Pharm Res 1993;10:S338.
12. Vormfelde S, Freudenthaler S, Mück W, Heyen P, Schmage N, Kuhlmann J, et al. Pharmacokinetics of cerivastatin in subjects with normal and impaired renal function. Br J Clin Pharmacol 1997; in press.
13. Shepherd J, Cobbe SM, Ford CG, Isles AR, Lorimer PW, MacFarlane JH, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. New Engl J Med 1995;333:1301-7.
14. Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, et al., for the Cholesterol and Recurrent Events Trial Investigator set. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. New Engl J Med 1996;335:1001-1009.
15. Pedersen TR and the Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-1389.
16. Bradford RH, Shear CL, Chremos AN, Dujovne C, Downton M, Franklin FA, et al. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolaemia. Arch Intern Med 1991;151:43-9.
17. Peters TK, Mehra M, Muratti EN. Efficacy and safety of fluvastatin in hypertensive patients. An analysis of a clinical trial database. Am J Hypertens 1993;6:340S-5S.
18. Hunninghake DB, Mellies MJ, Goldberg AC, Kuo PT, Kostis JB, Schrott HG, et al. Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. I. A dose-response study. Atherosclerosis 1990;85:81-94.
19. McDowell IFW, Smye M, Trinick T, Shortt JA, Archibald MP, Trimble ER, et al. Simvastatin in severe hypercholesterolaemia: a placebo-controlled trial. Br J Clin Pharmacol 1991;31:340-3.
20. Stein EA, Isaacsohn J, Stoltz R, Mazzu AL, Liu MC, Lane C, et al. Efficacy and safety of 0.8 mg dosage of cerivastatin, a novel HMG-CoA reductase inhibitor, (Abstract). J Am Coll Cardiol 1998;31:281A.
21. Hsu I, Spinler SA, Johnson NE. Comparative evaluation of the safety and efficacy of HMG-CoA reductase inhibitor monotherapy in the treatment of primary hypercholesterolemia. Ann Pharmacother 1995;29:743-59.
22. Bakker-Arkema RG. Efficacy and safety of a new HMG-CoA reductase inhibitor atorvastatin, in patients with hypertriglyceridemia. J Am Med Assoc 1996;275:128-33.
23. Stein EA, Lane M, Laskarzewski PL. Comparison of statins in hypertriglyceridemia. Am J Cardiol 1998;81:66B-9B.
24. Blum CB. Comparison of properties of four inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase. Am J Cardiol 1994;73:3D-11D.
25. Transon C, Leemann T, Dayer P. In vitro comparative inhibition profiles of major human drug metabolising cytochrome P450 isozymes (CYP2C9, CYP2D6 and CYP3A4) by HMG-CoA reductase inhibitors. Eur J Clin Pharmacol 1996;50:209-15.