The efficacy and six-week tolerability of simvastatin 80 and 160 mg/day

American Journal of Cardiology

Volumn 79, Issue 1, 1997, Pages 38-42

  Davidson, Michael H ^b   Stein, Evan A ^b   Dujovne, Carlos A ^b   Hunninghake, Donald B ^b   Weiss, Stuart R ^b   Knopp, Robert H ^b   Illingworth, D Roger ^b   Mitchel, Yale B ^a   Melino, Michael R ^b   Zupkis, Robert V ^b   Dobrinska, Michael R ^b   Amin, Raju D ^b   Tobert, Jonathan A ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DERIVATIVE; HYPOCHOLESTEROLEMIC AGENT; MEVINOLIN; SIMVASTATIN;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG TOLERANCE; FEMALE; HUMAN; MALE; MIDDLE AGED; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL;

ADULT; AGED; ANTICHOLESTEREMIC AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; DRUG TOLERANCE; FEMALE; HUMANS; LOVASTATIN; MALE; MIDDLE AGED; SIMVASTATIN;

EID: 0030635481     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-9149(96)00742-4     Document Type: Article

References (27)

1. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383-1389.
2. Pedersen TR, Berg K, Cook TJ, Færgeman O, Haghfelt T, Kjekshus J, Miettinen T, Musliner AT, Olsson AG, Pyörälä K, Thorgeirsson G, Tobert JA, Wedel H, Wilhelmsen L. Safety and tolerability of cholesterol lowering with Simvastatin during 5 years in the Scandinavian Simvastatin Survival Study (4S). Arch Intern Med 1996;156:2085-2092.
3. Chen Z, Peto R, Collins R, MacMahon S, Lu J, Li W. Serum cholesterol concentration and coronary heart disease in population with low cholesterol concentrations. Br Med J 1991;303:276-282.
4. Szatrowski TP, Peterson AV Jr., Shimizu Y, Prentice RL, Mason MW, Fukunaga Y, Kato H. Serum cholesterol, other risk factors, and cardiovascular disease in a Japanese cohort. J Chronic Dis 1984;37:569-584.
5. Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? Br Med J 1994;308:367-372.
6. Gould AL, Rossouw JE, Santanello NC, Heyse JF, Furberg CD. Cholesterol reduction yields clinical benefit: a new look at old data. Circulation 1995;91:2274-2282.
7. Gordon D. Cholesterol lowering and total mortality. In: Rifkind B, ed. Lowering Cholesterol in High-Risk Individuals and Populations. New York: Marcel Dekker; 1995;33-47.
8. MAAS Investigators. Effect of simvastatin on coronary atheroma: the Multicentre Anti-Atheroma Study (MAAS). Lancet 1994;344:633-638.
9. Myers G, Cooper G, Winn C, Smith S. The Centers for Disease Control - National Heart, Lung, and Blood Institute Lipid Standardization Program: an approach to accurate and precise lipid measurements. Clin Lab Med 1989;9:105-135.
10. Steiner P, Freidel J, Bremner W, Stein E. Standardization of micromethods for plasma cholesterol, triglyceride and HDL-cholesterol with the lipid clinics' methodology. J Clin Chem 1981;19:850.
11. Warnick G, Albers J. A comprehensive evaluation of the heparin manganese precipitation procedure for estimating high-density lipoprotein cholesterol. J Lipid Res 1978;19:65-76.
12. Lipid Research Clinics Program. Manual of Laboratory Operations Lipid and Lipoprotein Analysis. Washington, DC: US Dept. of Health Education and Welfare. NIH Publication 75-628. 1982.
13. Albers J, Marcovina S, Kennedy H. International Federation of Clinical Chemistry Standardization Project for measurements of apolipoproteinsA-I and B-II: evaluation and selection of candidate reference materials. Clin Chem 1992;38:658-662.
14. Santer S, Santen R, Kulin H, Demers L. A model for validation of radioimmunoassay kit reagents: measurement of follitropin and lutropin in blood and urine. Clin Chem 1981;27:1892-1895.
15. Kubasik N, Hallaver G, Brodows R. Evaluation of direct solid phase radioimmunoassay for progesterone, useful for monitoring luteal function. Clin Chem 1984;30:284-286.
16. Tdx System Operator's Manual, Abbot Park, Illinois: Abbot Diagnostics, 1993.
17. Newton WT, McGuigan JE, Jaffe BM. Radioimmunoassay of peptides lacking tyrosine. J Lab Clin Med 1970;75:886-892.
18. Alberts A, Chen J, Kuron G, Hunt V, Huff J, Hoffman C, Rothrock J, Lopez M, Joshua H, HarrisE, Patchett A, Monaghan R, Currie S, Stapley E, Albers-Schonberg G, Hensens O, Hirshfied J, Hoogsteen K, Liesch J, Springer J. Mevinolin. A highly potent competitive inhibitor of hydroxymethylglutaryl-coenzyme A reductase and a cholesterol lowering agent. Proc Natl Acad Sci 1980;77:3957-3961.
19. Stubbs RJ, Schwartz MS, Gerson RJ, Thornton TJ, Bayne WF. Comparison of plasma profiles of lovastatin, simvastatin, and pravastatin in the dog. Drug Invest 1990;2 (suppl. 2):18-28.
20. Illingworth DR, Tobert JA. A review of clinical trials comparing HMG-CoA reductase inhibitors. Clin Ther 1994;16:366-385.
21. Pedersen TR, Tobert JA. Benefits and risks of HMG-CoA reductase inhibitors in the prevention of coronary heart disease: a reappraisal. Drug Safety 1996;1:11-24.
22. Arad Y, Ramakrishnan R, Ginsberg HN. Effects of lovastatin therapy on very-low-density lipoprotein triglyceride metabolism in subjects with combined hyperlipidemia: evidence for reduced assembly and secretion of triglyceriderich lipoproteins. Metabolism 1992;41:487-498.
23. Nawrocki JW, Weiss SR, Davidson MH, Sprecher DL, Schwartz SL, Lupien P-J, Jones PH, Haber HE, Black DM. Reduction of LDL cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA Reductase Inhibitor. Arterio Thromb Vasc Biol 1995;15:678-682.
24. Heinonen T, Stein E, Isaacsohn J, Davidson M, Davignon J, Montigny M, Tremblay G, Edwards A, Hunninghake D, Ooi T, Schrott H, Knopp R, Lupien PJ, Gagne C, McKenney J, Zavoral J, Sniderman A, Frohlich I, Later L, McQueen M, Steiner G, Gaudet D, Keilson L, Dujovne C, McLain R, Black D. Atorvastatin monotherapy in the treatment of severe hypercholesterolemia. Abstracts of the European Atherosclerosis Society 66th Annual Meeting, Florence, Italy. July 1996:214.
25. Arnadottir M, Eriksson LO, Thysell H, Karkas JD. Plasma concentration profiles of simvastatin 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitory activity in kidney transplant recipients with and without ciclosporin. Nephron 1993;6:410-413.
26. Smith PF, Eydelloth RS, Grossman SJ, Stubbs RJ, Schwartz MS, Germershausen J, Vyas KP, Kari PH, MacDonald JS. HMG-CoA reductase inhibitor-induced myopathy in the rat: cyclosporine A interaction and mechanism studies. J Pharmacol Exp Ther 1991;257:1225-1235.
27. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Summary of the second report of the national cholesterol education program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993;269:3015-3023.