Efficacy of 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitors in the treatment of patients with hypercholesterolemia: A meta-analysis of clinical trials

Clinical Therapeutics

Volumn 19, Issue 4, 1997, Pages 778-797

  Kong, Sheldon Xiaodong ^a,d   Crawford, Stephanie Y ^a   Gandhi, Sanjay K ^a   Seeger, John D ^a   Schumock, Glen T ^b   Lam, Nancy P ^a   Stubbings, JoAnn ^c   Schoen, Marieke Dekker ^a  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b Aspirus Wausau Hospital   (United States)

^c Projects Unlimited Inc   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Cholesterol; Fluvastatin; HMG CoA reductase inhibitors; Hypercholesterolemia; Lovastatin; Pravastatin; Simvastatin

Indexed keywords

FLUINDOSTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; PRAVASTATIN; SIMVASTATIN;

ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA BASE; DRUG EFFICACY; HUMAN; HYPERCHOLESTEROLEMIA; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; META ANALYSIS; MORBIDITY; MORTALITY;

EID: 0030801968     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(97)80102-6     Document Type: Article

References (90)

1. Heart and Stroke Facts: 1996 Statistical Supplement. Dallas, Tex: American Heart Association; 1996.
2. Gordon T, Kannel WB, Castelli WP, Dawber TR. Lipoproteins, cardiovascular disease, and death: The Framingham study. Arch Intern Med. 1981;141:1128-1131.
3. Castelli WP, Garrison RJ, Wilson PWF, et al. Incidence of coronary heart disease and lipoprotein cholesterol levels: The Framingham study. JAMA. 1986;256: 2835-2838.
4. Stamler J, Wentworth D, Neaton JD. Is the relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screenees of the Multiple Risk Factors Intervention Trial (MRFIT). JAMA. 1986; 256:2823-2828.
5. Angerson KM, Castelli WP, Levy D. Cholesterol and mortality: 30 years of follow up from the Framingham study. JAMA. 1987;257:2176-2180.
6. 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.
7. Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. NEJM. 1995;333:1301-1307.
8. Adult Treatment Panel II. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Circulation. 1994;89: 1329-1445.
9. Roberts WC. The underused miracle drugs: The statin drugs are to atherosclerosis what penicillin was to infectious disease. Am J Cardiol. 1996;78:377-378. Editorial.
10. Blum CB. Comparison of properties of four inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase. Am J Cardiol. 1994;73(14):3D-11D.
11. Illingworth DR, Tobert JA. A review of clinical trials comparing HMG-CoA reductase inhibitors. Clin Ther. 1994;16: 366-385.
12. L'Abbé KA, Desky AS, O'Rourke K. Meta-analysis in clinical research. Ann Intern Med. 1987;107:224-233.
13. Sacks HS, Berrier J, Reitman D, et al. Meta-analysis of randomized controlled trials. NEJM. 1987;316:450-455.
14. Thacker SB. Meta-analysis: A quantitative approach to research integration. JAMA. 1988;259:1685-1689.
15. Kong SX, Stubbings J. Assessing the economic value of pharmaceutical services and products. J Pharm Prac. 1995;8: 142-153.
16. Kong SX, Gandhi SK, Crawford SY, Seeger JD. Pharmacoeconomic evaluation of HMG-CoA reductase inhibitors in the treatment of hypercholesterolemia. Am J Managed Care. 1996;2:1055-1073.
17. Hedges LV. Estimation of effect size from a series of independent experiments. Psychol Bull. 1982;92:490-499.
18. Lovastatin Pravastatin Study Group. A multicenter comparative trial of lovastatin and pravastatin in the treatment of hypercholesterolemia. Am J Cardiol. 1993;71: 810-815.
19. Bard JM, Dallongeville J, Hagen E, et al. Comparison of the effect of fluvastatin, an hydroxymethyl glutaryl coenzyme A reductase inhibitor, and cholestyramine, a bile acid sequestrant, on lipoprotein particles defined by apolipoproteiri composition. Metabolism. 1995;44:1447-1454.
20. Betteridge DJ, Durrington PN, Fairhurst GJ, et al. Comparison of lipid-lowering effects of low-dose fluvastatin and conventional-dose gemfibrozil in patients with primary hypercholesterolemia. Am J Med. 1994;96(Suppl 6A):45S-54S.
21. Broyles F, Walden C, Hunninghake D, et al. Effect of fluvastatin on intermediate density lipoprotein (remnants) and other lipoprotein levels in hypercholesterolemia. Am J Cardiol. 1995;76(2):129A-135A.
22. Greten H, Beil FU, Schneider J, et al. Treatment of primary hypercholesterolemia: Fluvastatin versus bezafibrate. Am J Med. 1994;96(Suppl 6A):55S-63S.
23. Insull W, Black D, Dujovne C, et al. Efficacy and safety of once-daily vs twice-daily dosing with fluvastatin, a synthetic reductase inhibitor, in primary hypercholesterolemia. Arch Intern Med. 1994;154: 2449-2455.
24. Jacobson TA, Jokubaitis LA, Amorosa LF. Fluvastatin and niacin in hypercholesterolemia: A preliminary report on gender differences in efficacy. Am J Med. 1994; 96(Suppl 6A):64S-68S.
25. Jacotot B, Banga JD, Pfister P, Mehra M. Efficacy of a low dose-range of fluvastatin (XU 62-320) in the treatment of primary hypercholesterolemia. A dose-response study in 431 patients. Br J Clin Pharmacol. 1994;38:257-263.
26. Knopp RH, Frohlich J, Jokubaitis LA, et al. Efficacy and safety of fluvastatin in patients with non-insulin-dependent diabetes mellitus and hyperlipidemia. Am J Med. 1994;96(Suppl 6A):69S-78S.
27. Leitersdorf E, Eisenberg S, Eliav O, et al. Efficacy and safety of high dose fluvastatin in patients with familial hypercholesterolemia. Eur J Clin Pharmacol. 1993; 45:513-518.
28. Lintott C, Scott R, Bremer J, Shand B. Fluvastatin for dyslipoproteinemia, with or without concomitant chronic renal insufficiency. Am J Cardiol. 1995;76(2): 97A-101A.
29. Sprecher DL, Abrams J, Allen JW, et al. Low-dose combined therapy with fluvastatin and cholestyramine in hyperlipidemic patients. Ann Intern Med. 1994; 120:537-543.
30. Blankenhorn D, Azen S, Kramch D, et al. Coronary angiographic changes with lovastatin therapy. The Monitored Atherosclerosis Regression Study (MARS). Ann Intern Med. 1993;119:969-976.
31. Bradford RH, Shear CL, Chremos AN, 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 hypercholesterolemia. Arch Intern Med. 1991;151:43-49.
32. D'Agostino RB, Kannel WB, Stepanians MN, D'Agostino LC. A comparison between lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia. Am J Cardiol. 1992;69:28-34.
33. Farmer JA, Washington LC, Jones PH, et al. Comparative effects of simvastatin and lovastatin in patients with hypercholesterolemia. The Simvastatin and Lovastatin Multicenter Study participants. Clin Ther. 1992;14:708-717.
34. LaRosa JC, Applegate W, Crouse JR, et al. Cholesterol lowering in the elderly. Results of the Cholesterol Reduction in Seniors Program (CRISP) pilot study. Arch Intern Med. 1994;154:529-539.
35. Lovastatin Study Group IV. A multicenter comparison of lovastatin and probucol for treatment of severe primary hypercholesterolemia. Am J Cardiol. 1990;66(8): 22B-30B.
36. McPherson R, Bedard J, Connelly P, et al. Comparison of the short-term efficacy and tolerability of lovastatin and pravastatin in the management of primary hypercholesterolemia. Clin Ther. 1992;14:276-291.
37. McPherson R, Tsoukas C, Baines MG, et al. Effects of lovastatin on natural killer cell function and other immunological parameters in man. J Clin Immunol. 1993; 13:439-444.
38. Tikkanen MJ, Helve E, Jaattela A, et al. Comparison between lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia: The Finnish Multicenter Study. Am J Cardiol. 1988;62(15): 35J-43J.
39. Valles F, Anguita M, Anglada J, et al. A multicenter double-blind study comparing lovastatin and gemfibrozil in the treatment of primary hypercholesterolemia. Atherosclerosis. 1991;91(Suppl):S3-S9.
40. Beigel Y, Brook G, Eisenberg S, et al. Efficacy and safety of pravastatin once daily in primary moderate hypercholesterolemia: The Israeli experience. Isr J Med Sci. 1993;29:272-277.
41. Betteridge DJ, Bhatnager D, Bing RF, et al. Treatment of familial hypercholesterolaemia. United Kingdom Lipid Clinics Study of pravastatin and cholestyramine. BMJ. 1992;304:1335-1338.
42. Crepaldi G, Baggio G, Area M, et al. Pravastatin vs gemfibrozil in the treatment of primary hypercholesterolemia. Arch Intern Med. 1991;151:146-152.
43. Douste-Blazy P, Ribeiro VG, Seed M, European Study Group. Comparative study of the efficacy and tolerability of simvastatin and pravastatin in patients with primary hypercholesterolemia. Drug Invest. 1993;6:353-361.
44. Glasser SP, DiBianco R, Effron BA, et al. The efficacy and safety of pravastatin in patients aged 60 to 85 years with low-density lipoprotein cholesterol > 160 mg/dl. Am J Cardiol. 1996;77:83-85.
45. Hoogerbrugge N, Mol MJ, Van Dormaal JJ, et al. The efficacy and safety of pravastatin, compared to and in combination with bile acid binding resins, in familial hypercholesterolemia. J Intern Med. 1990; 228:261-266.
46. Hunninghake DB, Knopp RH, Schonfeld G, et al. Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. I. A dose-response study. Atherosclerosis. 1990;85:81-89.
47. Jacobson TA, Chin MM, Curry CL, et al. Efficacy and safety of pravastatin in African Americans with primary hypercholesterolemia. Arch Intern Med. 1995; 155:1900-1906.
48. Jukema JW, Bruschke AV, van Boven AJ, et al. Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic men with normal to moderately elevated serum cholesterol levels. The Regression Growth Evaluation Statin Study (REGRESS). Circulation. 1995;91:2528-2540.
49. Klausen IC, Gerdes LU, Meinertz H, et al. Apolipoprotein(a) polymorphism predicts the increase of Lp(a) by pravastatin in patients with familial hypercholesterolemia treated with bile acid sequestration. Eur J Clin Invest. 1993;23:240-245.
50. Lambrecht LJ, Malini PL. Efficacy and tolerability of simvastatin 20 mg vs pravastatin 20 mg in patients with primary hypercholesterolemia. Acta Cardiol. 1993; 48:541-554.
51. Pitt B, Mancini GB, Ellis SG, et al. Pravastatin Limitation of Atherosclerosis in the Coronary Arteries (PLAC I): Reduction in atherosclerosis progression and clinical events. PLAC I investigation. J Am Coll Cardiol. 1995;26:1133-1139.
52. Pravastatin Multicenter Study Group II. Comparative efficacy and safety of pravastatin and cholestyramine alone and combined in patients with hypercholesterolemia. Arch Intern Med. 1993;153: 1321-1329.
53. Pravastatin Multinational Study Group for Cardiac Risk Patients. Effects of pravastatin in patients with serum total cholesterol levels from 5.2 to 7.8 mmol/liter (200 to 300 mg/dl) plus two additional atherosclerotic risk factors. Am J Cardiol. 1993;72:1031-1037.
54. Salonen R, Nyyssonen K, Porkkala E, et al. Kuopio Atherosclerosis Prevention Study (KAPS). A population-based primary preventive trial of the effect of LDL lowering on atherosclerotic progression in carotid and femoral arteries. Circulation. 1995;92:1758-1764.
55. Santinga JT, Rosman HS, Rubenfire M, et al. Efficacy and safety of pravastatin in the long-term treatment of elderly patients with hypercholesterolemia. Am J Med. 1994;96:509-515.
56. Simvastatin Pravastatin Study Group. Comparison of the efficacy, safety and tolerability of simvastatin and pravastatin for hypercholesterolemia. Am J Cardiol. 1993; 71:1408-1414.
57. Steinhagen-Thiessen E. Comparative efficacy and tolerability of 5 and 10 mg simvastatin and 10 mg pravastatin in moderate primary hypercholesterolemia. Simvastatin Pravastatin European Study Group. Cardiology. 1994;85:244-254.
58. Wiklund O, Angelin B, Fager G, et al. Treatment of familial hypercholesterolemia: A controlled trial of the effects of pravastatin or cholestyramine therapy on lipoprotein and apolipoprotein levels. J Intern Med. 1990;228:241-247.
59. Wiklund O, Angelin B, Bergman M, et al. Pravastatin and gemfibrozil alone and in combination for the treatment of hypercholesterolemia. Am J Med. 1993;94:13-20.
60. Chan P, Lee CB, Lin TS, et al. The effectiveness and safety of low dose pravastatin in elderly hypertensive hypercholesterolemic subjects on antihypertensive therapy. Am J Hypertens. 1995;8: 1099-1104.
61. Capurso A, Resta F, Bertolini S, et al. Lipid control with low-dosage simvastatin in patients with moderate hypercholesterolemia. An Italian multicentre double-blind placebo-controlled study. Eur Heart J. 1992;13(Suppl B):11-16.
62. Haffner S, Orchard T, Stein E, et al. Effect of simvastatin on Lp(a) concentrations. Clin Cardiol. 1995;18:261-267.
63. Keech A, Collins R, MacMahon S, et al. Three-year follow-up of the Oxford Cholesterol Study: Assessment of the efficacy and safety of simvastatin in preparation for a large mortality study. Eur Heart J. 1994;15:255-269.
64. Multicentre Anti-Atheroma Study (MAAS). Effect of simvastatin on coronary atheroma. Lancet. 1994;344:633-638.
65. Pietro DA, Alexander S, Mantell G, et al. Effects of simvastatin and probucol in hypercholesterolemia (Simvastatin Multicenter Study Group II). Am J Cardiol. 1989;63:682-686.
66. Saito Y, Yoshida S, Nakaya N, et al. Comparison between morning and evening doses of simvastatin in hyperlipidemic subjects. A double-blind comparative study. Arteriosler Thromb. 1991;11:816-826.
67. Tuomilehto J, Guimaraes A, Kettner H, et al. Dose-response of simvastatin in primary hypercholesterolemia. J Cardiovasc Pharmacol. 1994;24:941-949.
68. Ziegler O, Drouin P. Safety, tolerability, and efficacy of simvastatin and fenofibrate - a multicenter study. Cardiology. 1990;77(Suppl 4):50-57.
69. Keys A, Aravanis C, Blackburn H. Seven Countries: A Multivariate Analysis of Death and Coronary Heart Disease. Cambridge, Mass: Harvard University Press; 1980:381.
70. Pooling Project Research Group. A relationship of blood pressure, serum cholesterol, smoking habit, relative weight, and ECG abnormalities to incidence of major coronary events: Final report of the Pooling Project. Monograph 60. Dallas, Tex: American Heart Association; 1978.
71. Bradford RH, Shear CL, Chremos AN, et al. Expanded Clinical Evaluation of Lovastatin (EXCEL) study: Design and patient characteristics of a double-blind, placebo-controlled study in patients with moderate hypercholesterolemia. Am J Cardiol. 1990;66(8):44B-55B.
72. Bradford RH, Shear CL, Chremos AN, et al. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results: Two-year efficacy and safety follow-up. Am J Cardiol. 1994;74:667-673.
73. ® (fluvastatin sodium) Capsules, NDA No. 20-261. Fluvastatin Study No. XUC 112-E-00. East Hanover, NJ: Sandoz Pharmaceuticals Corp.; 1994.
74. ® (fluvastatin sodium) Capsules, NDA No. 20-261. Fluvastatin Study No. 45. East Hanover, NJ: Sandoz Pharmaceuticals Corp.; 1995.
75. Sweany AE, Shapiro DR, Tate AC, et al. Effects of simvastatin versus gemfibrozil on lipids and glucose control in patients with non-insulin-dependent diabetes mellitus. NIDDM Study Group. Clin Ther. 1995;17:186-203.
76. Raskin P, Ganda OP, Schwartz S, et al. Efficacy and safety of pravastatin in the treatment of patients with type I or type II diabetes mellitus and hypercholesterolemia. Am J Med. 1995;99:362-369.
77. Crouse JR III, Byington RP, Bond MG, et al. Pravastatin, Lipids, and Atherosclerosis in the Carotid Arteries (PLAC-II). Am J Cardiol. 1995;75:455-459.
78. Waters D, Higginson L, Gladstone P, et al. Effects of cholesterol lowering on the progression of coronary atherosclerosis in women. A Canadian Coronary Atherosclerosis Intervention Trial (CCAIT) substudy. Circulation. 1995;92:2404-2410.
79. Hagen E, Istad H, Ose L, et al. Fluvastatin efficacy and tolerability in comparison and in combination with cholestyramine. Eur J Clin Pharmacol. 1994;46:445-449.
80. Slunga L, Johnson O, Dahlen GH. Changes in Lp(a) lipoprotein levels during the treatment of hypercholesterolemia with simvastatin. Eur J Clin Pharmacol. 1992;43:369-373.
81. Knopp RH, Frolich JJ. Efficacy and safety of fluvastatin in patients with non-insulin-dependent diabetes mellitus and hyperlipidemia: Preliminary report. Am J Cardiol. 1994;73(14):39D-41D.
82. Bakker-Arkema RG, Davidson MH, Goldstein RJ, et al. Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia. JAMA. 1996;275:128-133.
83. Best JD, Nicholson GC, O'Neal DN, et al. Atorvastatin and simvastatin reduce elevated cholesterol in non-insulin dependent diabetes. Diabetes Nutr Metab Clin Exp. 1996;9:74-80.
84. Cilla DD, Gibson DM, Whitfield LR, Sedman AJ. Pharmacodynamic effects and pharmacokinetics of atorvastatin after administration to normocholesterolemic subjects in the morning and evening. J Clin Pharmacol. 1996;36:604-609.
85. Cilla DD, Whitfield LR, Gibson DM, et al. Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects. Clin Pharmacol Ther. 1996;60:687-695.
86. Nawrocki JW, Weiss SR, Davidson MH, et al. Reduction of LDL-cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor. Arterioscler Thromb Vasc Biol. 1995;15: 678-682.
87. Martens LL, Guibert R. Cost-effectiveness analysis of lipid-modifying therapy in Canada: Comparison of HMG-CoA reductase inhibitors in the primary prevention of coronary heart disease. Clin Ther. 1994;16:1052-1062.
88. Goldman L, Weinstein MC, Goldman PA, Williams LW. Cost-effectiveness of HMG-CoA reductase inhibition for primary and secondary prevention of coronary heart disease. JAMA. 1991;265:1145-1151.
89. Lau J, Antman EM, Jimenez-Silva J, et al. Cumulative meta-analysis of therapeutic trials for myocardial infarction. NEJM. 1992;327:248-254.
90. Antman EM, Lau J, Kupelnick B, et al. A comparison of results of meta-analysis of randomized control trials and recommendations of clinical experts. Treatment for myocardial infarction. JAMA. 1992;268: 240-248.