Forecasting patient outcomes in the management of hyperlipidemia

Archives of Internal Medicine

Volumn 159, Issue 6, 1999, Pages 569-575

  Brier, Kenneth L ^a   Tornow, John J ^b   Ries, Andrea J ^c,d   Weber, Mary P ^c,e   Downs, John R ^c  

^a Micromedex Inc   (United States)

^b Found Health Federal Services Inc   (United States)

^c Dept of Def Pharmacoeconomic Ctr ^*  (United States)

^d Trinity Valley Medical Center   (United States)

^e Naval Ambulatory Care Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTILIPEMIC AGENT; CHOLESTEROL; COLESTIPOL; COLESTYRAMINE; FLUINDOSTATIN; HIGH DENSITY LIPOPROTEIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NICOTINIC ACID; PRAVASTATIN; SIMVASTATIN;

ADULT; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; FEMALE; FORECASTING; HUMAN; HYPERLIPIDEMIA; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; PRIMARY PREVENTION; PRIORITY JOURNAL; SECONDARY PREVENTION; TREATMENT OUTCOME;

ADULT; AGED; ANTICHOLESTEREMIC AGENTS; CHOLESTEROL, LDL; HUMANS; HYPERCHOLESTEROLEMIA; MEDLINE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; RISK; RISK FACTORS; TREATMENT OUTCOME;

EID: 0033594218     PISSN: 00039926     EISSN: None     Source Type: Journal    
DOI: 10.1001/archinte.159.6.569     Document Type: Article

References (104)

1. National Cholesterol Education Program. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Bethesda, Md: National Institutes of Health, National Heart, Lung, and Blood Institute; 1993. Publication 93-3095.
2. 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.
3. Gordon T, Kannel WB, Castelli WP, Dawber TR. Lipoproteins, cardiovascular disease, and death: the Framingham Study. Arch Intern Med. 1981;141:1128-1131.
4. Castelli WP, Garrison RJ, Wilson PWF, Abbott RD, Kalousdian S, Kannel WB. Incidence of coronary heart disease and lipoprotein cholesterol levels: the Framingham Study. JAMA. 1986;256:2835-2838.
5. Martin MJ, Hulley SB, Browner WS, Kuller LH, Wentworth D. Serum cholesterol, blood pressure, and mortality: implication from a cohort of 361 662 men. Lancet. 1986;2:933-936.
6. Schaefer EJ, Lamon-Fava S, Jenner JL, et al. Lipoprotein (a) levels and risk of coronary heart disease in men: the Lipid Research Clinics Coronary Primary Prevention Trial. JAMA. 1994;271:999-1003.
7. Kannel WB, Castelli WP, Gordon T, McNamara PM. Serum cholesterol, lipoproteins, and the risk of coronary heart disease: the Framingham Study. Ann Intern Med. 1971;74:1-12.
8. Canner PL, Berge KB, Wenger NK, et al. Fifteen year mortality in coronary drug project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986;8:1245-1255.
9. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results, I: reduction in incidence of coronary heart disease. JAMA. 1984;251:351-364.
10. Frick MH, Elo O, Haapa K, et al. Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia: safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med. 1987;317:1237-1245.
11. Pearson TA, Marx HJ. The rapid reduction in cardiac events with lipid-lowering therapy: mechanisms and implications [editorial]. Am J Cardiol. 1993;72:1072-1073.
12. The 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.
13. Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial Results, II: the relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA. 1984;251:365-374.
14. 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.
15. Watts GF, Lewis B, Brunt JNH, et al. Effects on coronary artery disease of lipid-lowering diet, or diet plus cholestyramine, in the St Thomas' Atherosclerosis Regression Study (STARS). Lancet. 1992;339:563-569.
16. Furberg CD, Pitt B, Byington RP, Park JS, McGovern ME, for the PLAC I and PLAC II Investigators. Reduction in coronary events during treatment with pravastatin. Am J Cardiol. 1995;76:60C-63C.
17. Crouse JR, Byington RP, Bond MG, et al. Pravastatin, lipids, and atherosclerosis in the carotid arteries (PLAC-II). Am J Cardiol. 1995;75:455-459.
18. Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333:1301-1307.
19. Illingworth DR, Stein EA, Mitchel YB, et al. Comparative effects of lovastatin and niacin in primary hypercholesterolemia: a prospective trial. Arch Intern Med. 1994;154:1586-1595.
20. Blankenhorn DH, Azen SP, Kramsch DM, et al. Coronary angiographic changes with lovastatin therapy: the Monitored Atherosclerosis Regression Study (MARS). Ann Intern Med. 1993;119:969-976.
21. Brown G, Albers JJ, Fisher LD, et al. Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B. N Engl J Med. 1990;323:1289-1298.
22. Kane JP, Malloy MJ, Ports TA, Phillips NR, Diehl JC, Havel RJ. Regression of coronary atherosclerosis during treatment of familial hypercholesterolemia with combined drug regimens. JAMA. 1990;264:3007-3012.
23. Brensike JF, Levy RI, Kelsey SF, et al. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984;69:313-324.
24. Furberg CD, Byington RP, Crouse JR, Espeland MA. Pravastatin, lipids, and major coronary events. Am J Cardiol. 1994;73:1133-1134.
25. Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987;257: 3233-3240.
26. Buchwald H, Varco RL, Matts JP, et al. Effect of partial ileal bypass surgery on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia: Report of the Program on the Surgical Control of the Hyperlipidemias (POSCH). N Engl J Med. 1990;323:946-955.
27. Hamilton VH, Racicot F, Zowall H, Coupal L, Grover SA. The cost-effectiveness of HMG-CoA reductase inhibitors to prevent coronary heart disease: estimating the benefits of increasing HDL-C. JAMA. 1995;273:1032-1038.
28. Johnson CL, Rifkind BM, Sempos CT, et al. Declining serum total cholesterol levels among US adults: the National Health and Nutrition Examination Surveys. JAMA. 1993;269:3002-3008.
29. Sempos CT, Cleeman JI, Carroll MD, et al. Prevalence of high blood cholesterol among US adults: an update based on guidelines from the Second Report of the National Cholesterol Education Program Adult Treatment Panel. JAMA. 1993;269:3009-3014.
30. Kinlay S, O'Connell D, Evans D, Halliday J. A new method of estimating cost-effectiveness of cholesterol reduction therapy for prevention of heart disease. Pharmacoeconomics. 1994;5:238-248.
31. The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Checklist of information for inclusion in reports of clinical trials. Ann Intern Med. 1996;124:741-743.
32. Denke MA, Grundy SM. Efficacy of low-dose cholesterol-lowering drug therapy in men with moderate hypercholesterolemia. Arch Intern Med. 1995;155:393-399.
33. Tonstad S, Knudtzen J, Sivertsen M, Refsum H, Ose L. Efficacy and safety of choletyramine therapy in peripubertal and prepubertal children with familial hypercholesterolemia. J Pediatr 1996;129:42-49.
34. Gary A, Grundy SM. Cholestyramine therapy for dyslipidemia in non-insulin-dependent diabetes mellitus: a short term, double blind, crossover trial. Ann Intern Med. 1994;21:416-422.
35. Simvastatin (Zocor) [package insert]. West Point, Pa: Merck & Co Inc; 1995.
36. 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.
37. Hagen E, Instad H, Ose L, et al. Fluvastatin efficacy and tolerability in comparison and in combination with cholestyramine. Eur J Clin Pharmacol. 1994;46: 445-449.
38. Simons LA, Nestel PJ, Clifton P, Janus ED, Simons J, Parfitt A. Treatment of primary hypercholesterolaemia with pravastatin: efficacy and safety over three years. Med J Aust. 1992;157:584-589.
39. Sweeney ME, Fletcher BJ, Rice CR, et al. Efficacy and compliance with cholestyramine bar versus powder in the treatment of hyperlipidemia. Am J Med. 1991;90:469-473.
40. Kwitterovich PD, Zavoral JH, Kafonek SD, Bullemer F, Kittner B. Treatment of patients with elevated plasma levels of low-density lipoproteins with a cholestyramine tablet compared with cholestyramine powder. Curr Ther Res. 1992; 52:330-336.
41. Superko HR, Greenland P, Manchester RA, et al. Effectiveness of low-dose colestipol therapy in patients with moderate hypercholesterolemia. Am J Cardiol. 1992; 70:135-140.
42. Spence JD, Huff MW, Heidenheim P, et al. Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia. Ann Intern Med. 1995; 123:493-499.
43. Tonstad S, Sivertsen M, Aksnes, Ose L. Low dose colestipol in adolescents with familial hypercholesterolemia. Arch Dis Child. 1996;74:157-160.
44. Lyons D, Webster J, Fowler G, Petrie JC. Colestipol at varying dosage intervals in the treatment of moderate hypercholesterolaemia. Br J Clin Pharmacol. 1994; 37:59-62.
45. Insull W, Black D, Dujovone C, et al. Efficacy and safety of once-daily vs twice-daily dosing fluvastatin, a synthetic reductase inhibitor, in primary hypercholesterolemia. Arch Intern Med. 1994;154:2449-2455.
46. Sandoz Pharmaceutical Corp. Fluvastatin Study No. 24: Multicenter Double-blind Crossover Study of the Safety, Bioavailability, and Efficacy of Fluvastatin Administered 20 mg Once a Day at Bedtime or With the Evening Meal. Hanover, NJ: Sandoz-Pharmaceuticals Corp; 1994.
47. Sandoz Pharmaceuticals Corp. Fluvastatin Study No. 22: Multicenter Double-blind Evaluation of the Safety and Contribution to the Efficacy of Concomitant Fluvastatin and Open-Label Cholestyramine. Hanover, NJ: Sandoz Pharmaceuticals Corp; 1994.
48. Sandoz Pharmaceuticals Corp. Fluvastatin Study No. 41: Evaluation of the Safety and Efficacy of Fluvastatin With and Without Concomitant Open-Label Niacin. Hanover, NJ: Sandoz Pharmaceuticals Corp; 1994.
49. Davidson MH. Fluvastatin Long-term Extension Trial (FLUENT): summary of efficacy and safety. Am J Med. 1994;96(suppl 6A):41S-44S.
50. Jacobson TA, Amorosa LF. Combination therapy with fluvastatin and niacin in hypercholesterolemia: a preliminary report on safety. Am J Cardiol. 1994;73: 25D-29D.
51. 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.
52. Sandoz Pharmaceuticals Corp. Fluvastatin Study No. 20: Multicenter Double-blind Evaluation of the Safety and Efficacy of Fluvastatin. Hanover, NJ: Sandoz Pharmaceuticals Corp; 1994.
53. Dallongeville J, Fruchart JC, Pfister P, Bard JM. Fluvastatin reduces levels of plasma apo B-containing particles and increases those of LpA-I. Am J Med. 1994;96(suppl 6A):32S-36S.
54. Muratti EN, Peters TK, Leitersdorf E. Fluvastatin in familial hypercholesterolemia: a cohort analysis of the response to combination treatment. Am J Cardiol. 1994;73:30D-38D.
55. Jones P, Kafonek S, Laurora I, Hunninghake D. Comparative dose efficacy study atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES Study). Am J Cardiol. 1998;81: 582-587.
56. Smit JW, Jansen GH, de Bruin TW, Erkelens DW. Treatment of combined hyperlipidemia with fluvastatin and gemfibrozil, alone or in combination. Am J Cardiol. 1995;76:126A-128A.
57. Lintott CJ, Scott RS, Brener JM, Shand BI. Fluvastatin for dyslipo-proteinemia, with or without concomitant chronic renal insufficiency. Am J Cardiol. 1995; 76:97A-101A.
58. Milani M, Cimminiello C, Merlo B, Lorena M, Arapaia G, Bonfardeci G. Effects of fluvastatin and pravastatin on lipid profiles and thromboxane production in type IIa hypercholesterolemia. Am J Cardiol. 1995;76:51A-53A.
59. Banga JD, Jacotot B, Pfister P, Mehra M. Long-term treatment of hypercholesterolemia with fluvastatin: a 52 week multicenter safety and efficacy study, French-Dutch Fluvastatin Study Group. Am J Med. 1994;96:87S-93S.
60. Knopp RH, Frohlich J, Jokubaitis LA, Dawson K, Broyles FE, Gomez-Coronado D. Efficacy and safety of fluvastatin in patients with non-insulin-dependent diabetes mellitus and hyperlipidemia. Am J Med. 1994;96:69S-78S.
61. Peters TK, Muratti EN, Mehra M. Fluvastatin in primary hypercholesterolemia -efficacy and safety in patients at high risk: an analysis of a clinical trial database. Am J Med. 1994;96:79S-83S.
62. Greten H, Beil FU, Schneider J, et al. Treatment of primary hypercholesterolemia: fluvastatin versus benzafibrate. Am J Med. 1994;96(suppl 6A):55S-63S.
63. Lovastatin (Mevacor) [package insert]. West Point, Pa: Merck & Co Inc; 1995.
64. Rubinstein A, Lurie Y, Groskop I, Weintrob M. Cholesterol-lowering effects of 10 mg daily dose of lovastatin in patients with initial total cholesterol levels 200 to 240 mg/dL (5.18 to 6.21 mmol/liter). Am J Cardiol. 1991;68:1123-1126.
65. Arca M, Vega GL, Grundy SM. Hypercholesterolemia in postmenopausal women: metabolic defects and response to low-dose lovastatin. JAMA. 1994;271: 453-459.
66. Sandoz Pharmaceutical Corp. Fluvastatin Study No. 21. Hanover, NJ: Sandoz Pharmaceutical Corp; 1994.
67. 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.
68. The Lovastatin-Pravastatin Study Group. A multicenter comparative trial of lovastatin and pravastatin in the treatment of hypercholesterolemia. Am J Cardiol. 1993;71:810-815.
69. Farmer JA, Washington LC, Jones PH, Shapiro DR, Gotto AM, Mantell G. Comparative effects of simvastatin and lovastatin in patients with hypercholesterolemia. Clin Ther. 1992;14:708-717.
70. Bradford RH, Downton M, Chremos AN, et al. Efficacy and tolerability of lovastatin in 3390 women with moderate hypercholesterolemia. Ann Intern Med. 1993;118:850-855.
71. Richter WO, Jacob BG, Schwandt P. Comparative effects of two HMG-CoA reductase inhibitors (lovastatin and pravastatin) on serum lipids and lipoprotein. Int J Tissue React. 1991;13:107-110.
72. Illingworth DR, Bacon S, Pappu AS, Sexton GJ. Comparative hypolipidemic effects of lovastatin and simvastatin in patients with heterozygous familial hypercholesterolemia. Atherosclerosis. 1992;96:53-64.
73. Schrott HG, Stein EA, Dujovne CA, et al. Enhanced low-density lipoprotein cholesterol reduction and cost-effectiveness by low-dose colestipol plus lovastatin combination therapy. Am J Cardiol. 1995;75:34-39.
74. Cobb MM, Teitelbaum HS, Breslow JL. Lovastatin efficacy in reducing low-density lipoprotein cholesterol levels on high-vs low-fat diets. JAMA. 1991; 265:997-1001.
75. Lovastatin Study Groups I through IV. Lovastatin 5-year safety and efficacy study. Arch Intern Med. 1993;153:1079-1087.
76. McKenney JM, Proctor JD, Harris S, Chinchili VM. A comparison of the efficacy and toxic effects of sustained-vs immediate-release niacin in hypercholesterolemic patients. JAMA. 1994;271:672-677.
77. Keenan JM, Fontaine PL, Wenz JB, Myers S, Huang ZQ, Ripsin CM. Niacin revisited: a randomized, controlled trial of wax-matrix sustained-release niacin in hypercholesterolemia. Arch Intern Med. 1991;151:1424-1432.
78. Davignon J, Roederer G, Montigny M, et al. Comparative efficacy and safety of pravastatin, nicotinic acid and the two combined in patients with hypercholesterolemia. Am J Cardiol. 1994;73:339-345.
79. Jones PH, Farmer JA, Cressman MD, McKenney JM, Wright JT, Proctor JD. Once-daily pravastatin in patients with primary hypercholesterolemia: a dose response study. Clin Cardiol. 1991;14:146-151.
80. The Simvastatin-Pravastatin Study Group. Comparison of the efficacy, safety, and tolerability of simvastatin and pravastatin for hypercholesterolemia. Am J Cardiol. 1993;71:1408-1414.
81. Malini PL, Ambrosioni E, De Divitiis O, Di Somma S, Rosiello G, Trimarco B. Simvastatin versus pravastatin: efficacy and tolerability in patients with primary hypercholesterolemia. Clin Ther. 1991;13:500-510.
82. 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.
83. European Study Group. Efficacy and tolerability of simvastatin and pravastatin in patients with primary hypercholesterolemia (multicountry comparative study). Am J Cardiol. 1992;70:1281-1286.
84. Morris R, Robinson G, Tilyard M, Gurr E. Pravastatin and risk factor modification in patients with moderate primary hypercholesterolemia. N Z Med J. 1996; 109:319-322.
85. Davidson MH, Testolin LM, Maki KC, von Duvillard S, Drennon KB. A comparison of estrogen replacement, pravastatin and combined treatment for the management of hypercholesterolemia in postmenopausal women. Arch Intern Med. 1997;137:1186-1192.
86. Douste-Blazy P, Ribeiro VG, Seed M, for the European Study Group. Comparative study of the efficacy and tolerability of simvastatin and pravastatin in patients with primary hypercholesterolaemia. Drug Invest. 1993;6:353-361.
87. Lambrecht LJ, Malini PL, for the European Study Group. Efficacy and tolerability of simvastatin 20 mg vs pravastatin 20 mg in patients with primary hypercholesterolemia. Acta Cardiol. 1993;48:541-554.
88. Pravastatin (Pravachol) [package insert]. New York, NY: Bristol-Myers Squibb Co; 1995.
89. Wilkund 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.
90. Lintott CJ, Scott RS, Sutherland WH, Bremer J. Treating hypercholesterolaemia with HMG-CoA reductase inhibitors: a direct comparison of simvastatin and pravastatin. Aust N Z J Med. 1993;23:381-386.
91. Arnadottir M, Eriksson LO, Germershausen JI, Thysell H. Low-dose simvastatin is a well-tolerated and efficacious cholesterol-lowering agent in ciclosporin-treated kidney transplant recipients: double-blind, randomized, placebo-controlled study in 40 patients. Nephron. 1994;68:57-62.
92. Miserez AR, Rossi FA, Keller U. Prediction of therapeutic response to simvastatin by pretreatment lipid concentrations in 2082 subjects. Eur J Clin Pharmacol. 1994;46:107-114.
93. Farnier M, Bonnefous F, Debbas N, Irvine A. Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia. Arch Intern Med. 1994;154:441-449.
94. Fluvastatin (Lescol) [package insert]. East Hanover, NJ: Sandoz Pharmaceuticals Corp; 1995.
95. Erkelens DW. Combination drug therapy with HMG-CoA reductase inhibitors and bile acid sequestrants for hypercholesterolemia. Cardiology. 1990;77 (suppl 4):33-38.
96. Simons LA, Simons J, Parfill A. Successful management of primary hypercholesterolaemia with simvastatin and low-dose colestipol. Med J Aust. 1992;157: 455-459.
97. Heudebert GR, Van Ruiswyk J, Hiatt J, Schectman G. Combination drug therapy for hypercholesterolemia: the trade-off between cost and simplicity. Arch Intern Med. 1993;153:1828-1837.
98. Colestipol (Colestid) [package insert]. Kalamazoo, Mich: Pharmacia & Upjohn Co; 1994.
99. Goldman L, Weinstein MC, Goldman PA. Cost-effectiveness of HMG-CoA reductase inhibition for primary and secondary prevention of coronary disease. JAMA. 1991;265:1145-1151.
100. Cholesterol management and practice guidelines at Kaiser Permanente Southern California: designing prevention programs - from research to reality. Med Interface. 1993;6:9-14.
101. 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.
102. Stalenhoef AFH, Lansberg PJ, Kroon AA, et al. Treatment of primary hypercholesterolaemia - short-term efficacy and safety of increasing doses of simvastatin and pravastatin: a double-blind comparative study. J Intern Med. 1993; 234:77-82.
103. Walsh JM, Grady D. Treatment of hyperlipidemia in women. JAMA. 1995;274: 1152-1158.
104. Bertolini S, Bon GB, Campbell LM, et al. Efficacy and safety of atorvastatin compared to pravastatin in patients with hypercholesterolemia. Atherosclerosis. 1997; 130:191-197.