Dose-response characteristics of cholesterol-lowering drug therapies: Implications for treatment

Annals of Internal Medicine

Volumn 125, Issue 12, 1996, Pages 990-1000

  Schectman, Gordon ^a,b   Hiatt, Jan ^a,c  

^a Veterans Administration   (United States)

^b FROEDTERT MEMORIAL LUTHERAN HOSPITAL   (United States)

^c CLEMENT J ZABLOCKI VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BILE ACID; COLESTIPOL; COLESTYRAMINE; FLUINDOSTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; HYPOCHOLESTEROLEMIC AGENT; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; NICOTINIC ACID; PRAVASTATIN; SIMVASTATIN;

CLINICAL TRIAL; DIET THERAPY; DOSE RESPONSE; GASTROINTESTINAL TOXICITY; HEARTBURN; HUMAN; HYPERCHOLESTEROLEMIA; LIVER TOXICITY; MYOPATHY; PRIORITY JOURNAL; REVIEW; SKIN MANIFESTATION; SLEEP DISORDER; SUSTAINED RELEASE PREPARATION;

EID: 0030447520     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-125-12-199612150-00011     Document Type: Review

References (72)

1. Brown BG, Zhao XQ, Sacco DE, Albers JJ. Lipid lowering and plaque regression. New insights into prevention of plaque disruption and clinical events in coronary disease. Circulation. 1993;87:1781-91.
2. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1985;8:1245-55.
3. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344:1383-9.
4. Frick MH, Elo O, Haapa K, Heinonen OP, Heinsalmi P, Helo P, 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;317:1237-45.
5. The Lipid Research Clinics Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA. 1984;251:351-64.
6. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995;333:1301-7.
7. 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;269:3015-23.
8. 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). Circulation. 1994;89:1333-445.
9. Rubins HB, Robins SJ, Collins D, Iranmanesh A, Wilt TJ, Mann D, et al. Distribution of lipids in 8,500 men with coronary artery disease. Department of Veterans Affairs HDL Intervention Trial Study Group. Am J Cardiol. 1995;75:1196-201.
10. Sempos CT, Cleeman JI, Carroll MD, Johnson CL, Bachorik PS, Gordon DJ, 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;269:3009-14.
11. 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;153:1828-37.
12. 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 hypercholesterolemia. Arch Intern Med. 1991;151:43-9.
13. A multicenter comparison of lovastatin and cholestyramine therapy for severe primary hypercholesterolemia. The Lovastatin Study Group III. JAMA. 1988;260:359-66.
14. LaRosa JC, Applegate W, Crouse JR 3d, Hunninghake DB, Grimm R, Knopp R, et al. Cholesterol lowering in the elderly. Results of the Cholesterol Reduction in Seniors Program (CRISP) pilot study. Arch Intern Med. 1994;154:529-39.
15. A multicenter comparative trial of lovastatin and pravastatin in the treatment of hypercholesterolemia. The Lovastatin Pravastatin Study Group. Am J Cardiol. 1993;71:810-5.
16. Farmer JA, Washington LC, Jones PH, Shapiro DR, Getto AM Jr, Mantell G. Comparative effects of simvastatin and lovastatin in patients with hypercholesterolemia. The Simvastatin and Lovastatin Multicenter Study Participants. Clin Ther. 1992;14:708-17.
17. McPherson R, Bedard J, Connelly P, Curnew G, Davignon J, Echenberg D, et al. Comparison of the short-term efficacy and tolerability of lovastatin and pravastatin in the management of primary hypercholesterolemia. Clin Ther. 1992;14:276-91.
18. Wiklund O, Angelin B, Fager G, Eriksson M, Olofsson SO, Berglund L, et al. Treatment of familial hypercholesterolaemia: a controlled trial of the effects of pravastatin or cholestyramine therapy on lipoprotein and apolipoprotein levels. J Intern Med. 1990;228:241-7.
19. Stalenhoef AF, Lansberg PJ, Kroon AA, Kortmann B, De Haan AF, Stuyt PM, 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.
20. Keech A, Collins R, MacMahon S, Armitage J, Lawson A, Wallendszus K, 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;15:255-69.
21. Saito Y, Yoshida S, Nakaya N, Hata Y, Goto Y. Comparison between morning and evening doses of simvastatin in hyperlipidemic subjects. A double-blind comparative study. Arterioscler Thromb. 1991;11:816-26.
22. Stein E, Kreisberg R, Miller V, Mantell G, Washington L, Shapiro DR. Effects of simvastatin and cholestyramine in familial and nonfamilial hypercholesterolemia. Multicenter Group I. Arch Intern Med. 1990;150:341-5.
23. Steinhagen-Thiessen E. Comparative efficacy and tolerability of 5 and 10 mg simvastatin and 10 mg pravastatin in moderate primary hypercholesterol-emia. Simvastatin Pravastatin European Study Group. Cardiology. 1994;85:244-54.
24. Tuomilehto J, Guimaraes AC, Kenner H, Lithell H, Pitkanen M, Sailer D, et al. Dose-response of simvastatin in primary hypercholesterolemia. J Cardiovasc Pharmacol. 1994;24:941-9.
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. The French-Dutch Fluvastatin Study Group. Br J Clin Pharmacol. 1994;38:257-63.
26. Leitendorf E, Eisenberg S, Eliav O, Berkman N, Dann EJ, Landsberger D, et al. Efficacy and safety of high dose fluvastatin in patients with familial hypercholesterolaemia. Eur J Clin Pharmacol. 1993;45:513-8.
27. Superko HR, Greenland P, Manchester RA, Andreadis NA, Schectman G, West NH, et al. Effectiveness of low-dose colestipol therapy in patients with moderate hypercholesterolemia. Am J Cardiol. 1992;70:135-40.
28. Vessby B, Kostner G, Lithell H, Thomis J. Diverging effects of cholestyramine on apolipoprotein B and lipoprotein Lp(a). A dose-response study of the effects of cholestyramine in hypercholesterolaemia. Atherosclerosis. 1982;44:61-71.
29. Vecchio TJ, Linden CV, O'Connell MJ, Heilman J. Comparative efficacy of colestipol and clofibrate in type lia hyperlipoproteinemia. Arch Intern Med. 1982;142:721-3.
30. Angelin B, Einarsson K. Cholestyramine in type IIa hyperlipoproteinemia. Is low-dose treatment feasible? Atherosclerosis. 1981;38:33-8.
31. Hunninghake DB, Probstfield JL, Crow LO, Isaacson SO. Effect of colestipol and clofibrate on plasma lipid and lipoproteins in type IIa hyperlipoproteinemia. Metabolism. 1981;30:605-9.
32. Witztum JL, Schonfeld G, Weidman SW, Giese WE, Dillingham MA. Bile sequestrant therapy alters the composition of low-density and high-density lipoproteins. Metabolism. 1979;28:221-9.
33. McKenney JM, Proctor JD, Harris S, Chinchilli VM. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA. 1994;271:672-7.
34. Knopp RH, Ginsberg J, Albers JJ, Hoff C, Ogilvie JT, Warnick GR, et al. Contrasting effects of unmodified and time-release forms of niacin on lipoproteins in hyperlipidemic subjects: clues to mechanism of action of niacin. Metabolism. 1985;34:642-50.
35. 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;151:1424-32.
36. Sprecher DL, Abrams J, Allen JW, Keane WF, Chrysant SG, Ginsberg H, et al. Low-dose combined therapy with fluvastatin and cholestyramine in hyperlipidemic patients. Ann Intern Med. 1994;120:537-43.
37. Comparative efficacy and safety of pravastatin and cholestyramine alone and combined in patients with hypercholesterolemia. Pravastatin Multicenter Study Group II. Arch Intern Med 1993;153:1321-9.
38. Simons LA, Simons J, Parfitt A. Successful management of primary hypercholesterolemia with simvastatin and low-dose colestipol. Med J Aust. 1992;157:455-9.
39. Davignon J, Roederer G, Montigny M, Hayden MR, Tan MH, Connelly PW, et al. Comparative efficacy and safety of pravastatin, nicotinic acid and the two combined in patients with hypercholesterolemia. Am J Cardiol 1994;73:339-45
40. Jacobson TA, Chin MM, Fromell GJ, Jokubaitis LA, Amorosa LF. Fluvastatin with and without niacin for hypercholesterolemia. Am J Cardiol. 1994;74:149-54.
41. Vacek JL, Dittmeier G, Chiarelli T, White J, Bell HH. Comparison of lovastatin (20 mg) and nicotinic acid (1.2 g) with either drug alone for type II hyperlipoproteinemia. Am J Cardiol. 1995;76:182-4.
42. Denke MA, Grundy SM. Efficacy of low-dose cholesterol-lowering drug therapy in men with moderate hypercholesterolemia. Arch Intern Med. 1995;155:393-9.
43. Hagen E, Istad H, Ose L, Bodd E, Eriksen H, Selvig V, et al. Fluvastatin efficacy and tolerability in comparison and in combination with cholestyramine. Eur J Clin Pharmacol. 1994;46:445-9.
44. Schrott HG, Stein EA, Dujovne CA, Davidson MH, Goris GB, Oliphant TH, et al. Enhanced low-density lipoprotein cholesterol reduction and cost-effectiveness by low-dose colestipol plus lovastatin combination therapy. Am J Cardiol. 1994;75:34-9.
45. Bowman W, Rand M. Principles of drug action. In: Bowman WC, Rand MJ. Textbook of Pharmacology. Oxford: Blackwell Scientific; 1980:39.16-39.43.
46. Denke MA. Cholesterol-lowering diets. A review of the evidence. Arch Intern Med. 1995;155:17-26.
47. Davidson MH, Kong JC, Drennan KB, Story K, Anderson GH. Efficacy of the National Cholesterol Education Program Step 1 diet. Arch Intern Med. 1996;156:305-12.
48. Caggiula AW, Watson JE, Kuller LH, Olson MB, Milas NC, Berry M, et al. Cholesterol-lowering intervention program. Effect of the step 1 diet in community office practices. Arch Intern Med. 1996;156:1205-13.
49. Hunninghake DB, Stein EA, Dujovne CA, Harris WS, Feldman EB, Miller VT, et al. The efficacy of intensive dietary therapy alone or combined with lovastatin in outpatients with hypercholesterolemia. N Engl J Med. 1993;328:1213-9.
50. Schaefer EJ, Lichtenstein AH, Lamon-Fava S, Contois JH, Li Z, Rasmussen H, et al. Efficacy of a National Cholesterol Education Program Step 2 diet in normolipidemic and hypercholesterolemic middle-aged and elderly men and women. Arterioscler Thromb Vasc Biol. 1995;15:1079-85.
51. Schectman G, Wolff N, Byrd JC, Hiatt JG, Hartz A. Physician extenders for cost-effective hypercholesterolemia. J Gen Intern Med. 1996;11:277-86.
52. Andrade SE, Walker AM, Gottlieb LK, Hollenberg NK, Testa MA, Saperia GM, et al. Discontinuation of antihyperlipidemic drugs - do rates reported in clinical trials reflect rates in primary care settings? N Engl J Med. 1995;332:1125-31.
53. Fraunfelder FW, Fraunfelder FT, Illingworth DR. Adverse ocular effects associated with niacin therapy. Br J Ophthalmol. 1995;79:54-6.
54. Gibbons LW, Gonzalez V, Gordon N, Grundy S. The prevalence of side effects with regular and sustained-release nicotinic acid. Am J Med. 1995;99:378-85.
55. Schectman G, Hiatt J, Hartz A. Evaluation of the effectiveness of lipid-lowering therapy (bile acid sequestrants, niacin, psyllium and lovastatin) for treating hypercholesterolemia in veterans. Am J Cardiol. 1993;71:759-65.
56. Martin-Jadraque R, Mostaza JM, Vega GL, Grundy SM. Effectiveness of low-dose crystalline nicotinic acid in men with low high-density lipoprotein cholesterol levels. Arch Intern Med. 1996;156:1081-8.
57. Gray DR, Morgan T, Chretien SD, Kashyap ML. Efficacy and safety of controlled-release niacin in dyslipoproteinemic veterans. Ann Intern Med. 1994;121:252-8.
58. Rader JI, Calvert RJ, Hathcock JN. Hepatic toxicity of unmodified and time-release preparations of niacin. Am J Med. 1992;92:77-81.
59. Rifkind BM. High-density lipoprotein cholesterol and coronary artery disease: survey of the evidence. Am J Cardiol. 1990;66:3A-6A.
60. Keenan JM, Wenz JB, Ripsin CM, Huang Z, McCaffrey DJ. A clinical trial of oat bran and niacin in the treatment of hyperlipidemia. J Fam Pract. 1992;34:313-9.
61. Davignon J, Roederer G, Montigny M, Hayden MR, Tan MH, Connelly PW, et al. Comparative efficacy and safety of pravastatin, nicotinic acid and the two combined in patients with hypercholesterolemia. Am J Cardiol. 1994;73:339-45.
62. Gray DR, Morgan T, Chretien SD, Kashyap ML. Efficacy and safety of controlled-release niacin in dyslipoproteinemic veterans. Ann Intern Med. 1994;121:252-8.
63. Luria MH. Effect of low-dose niacin on high-density lipoprotein cholesterol and total cholesterol/high-density lipoprotein cholesterol ratio. Arch Intern Med. 1988;148:2493-5.
64. Alderman JD, Pasternak RC, Sacks FM, Smith HS, Monrad ES, Grossman W. Effect of a modified, well-tolerated niacin regimen on serum total cholesterol, high density lipoprotein cholesterol and the cholesterol to high density lipoprotein ratio. Am J Cardiol. 1989;64:725-9.
65. Lavie CJ, Mailander L, Milani RV. Marked benefit with sustained-release niacin therapy in patients with isolated very low levels of high-density lipoprotein cholesterol and coronary artery disease. Am J Cardiol. 1992;69:1083-5.
66. Squires RW, Allison TG, Gau GT, Miller TD, Kottke BA. Low-dose, time release nicotinic acid: effects in selected patients with low concentrations of high-density lipoprotein cholesterol. Mayo Clin Proc. 1992;67:855-60.
67. Vega GL, Grundy SM. Lipoprotein responses to treatment with lovastatin, gemfibrozil, and nicotinic acid in normolipidemic patients with hypoalphalipoproteinemia. Arch Intern Med. 1994;154:73-82.
68. Illingworth DR, Stein EA, Mitchel YB, Dujovne CA, Frost PH, Knopp RH, et al. Comparative effects of lovastatin and niacin in primary hypercholesterolemia. A prospective trial. Arch Intern Med. 1994;154:1586-95.
69. King JM, Crouse JR, Terry JG, Morgan TM, Spray BJ, Miller NE. Evaluation of effects of unmodified niacin on fasting and postprandial plasma lipids in normolipidemic men with hypoalphalipoproteinemia. Am J Med. 1994;97:323-31.
70. Kinosian B, Glick H, Garland G. Cholesterol and coronary heart disease: predicting risks by levels and ratios. Ann Intern Med. 1994;121:641-7.
71. Sclar DA. Improving medication compliance: a review of selected issues. Clin Ther. 1991;13:436-40.
72. Salzman C. Medication compliance in the elderly. J Clin Psychiatry. 1995;56(Suppl 1):18-23.