Cholesterol reduction yields clinical benefit: A new look at old data

Circulation

Volumn 91, Issue 8, 1995, Pages 2274-2282

  Gould, A Lawrence ^a   Rossouw, Jacques E ^b   Santanello, Nancy C ^a   Heyse, Joseph F ^a   Furberg, Curt D ^c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

cholesterol; meta analysis; mortality

Indexed keywords

CHOLESTEROL; CLOFIBRATE; COLESTIPOL; COLESTYRAMINE; DEXTROTHYROXINE; ESTROGEN; FIBRIC ACID DERIVATIVE; GEMFIBROZIL; HORMONE; HYPOCHOLESTEROLEMIC AGENT; MEVINOLIN; NICOTINIC ACID; RESIN;

ARTICLE; CLINICAL TRIAL; DIET THERAPY; HUMAN; ILEUM BYPASS; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; META ANALYSIS; MORTALITY; PRIORITY JOURNAL; RISK ASSESSMENT;

EID: 0028897634     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.91.8.2274     Document Type: Article

References (72)

1. 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.
2. Davey-Smith G, Egger M. Commentary on the cholesterol papers. BMJ. 1994;308:1025-1027.
3. Law MR, Wald NJ. Disagreements are not substantial. BMJ. 1994;308:1027-1029.
4. Bonneux L, Barendregt JJ. Ischaemic heart disease and cholesterol. BMJ. 1994;308:1038. Letter.
5. Ravnskov U. Optimism about drug treatment is unjustified. BMJ. 1994;308:1038. Letter.
6. Ramsay LE, Yeo WW, Jackson PR. Effective diets are unpalatable. BMJ. 1994;308:1038-1039. Letter.
7. Sheldon TA. Drug trial deaths cannot be dismissed. BMJ. 1994; 308:1039. Letter.
8. Millo J. Hidden bias in observational study. BMJ. 1994;308:1039. Letter.
9. Sudlow CL, Macleod MR. "Cholesterol papers" add to the confusion. BMJ. 1994:308:1039-1040. Letter.
10. Heady JA, Morris JN, Oliver MF. . . . and mislead on adverse effects. BMJ. 1994;308:1040. Letter.
11. Vine DL, Hastings G. Absolute risk more informative than relative risk. BMJ. 1994;308:1040. Letter.
12. Durrington PN. Cholesterol reduction effective in established disease. BMJ. 1994;308:1040. Letter.
13. Dugdale A. . . . but does it increase lifespan in the others? BMJ. 1994;308:1041. Letter.
14. Law MR, Wu T, Wald NJ, Hackshaw A. Authors' reply. BMJ. 1994;308:1041. Reply.
15. Carlson LA, Rosenhamer G. Reduction of mortality in the Stockholm ischemic heart disease secondary prevention study by combined treatment with clofibrate and nicotinic acid. Acta Med Scand. 1988;223:405-418.
16. Group of Physicians of the Newcastle upon Tyne Region. Trial of clofibrate in the treatment of ischaemic heart disease: five year study by a group of physicians of the Newcastle upon Tyne region. BMJ. 1971;4:767-775.
17. 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.
18. Frick MH, Elo O, Hààpa K, Heinonen OP, Heinsalmi P, Helo P, Huttunen JK, Kaitaniemi P, Koskinen P, Manninen V, Mäenpää H, Mälkönen M, Mänttäri M, Norola S, Pasternack A, Pikkarainen J, Romo M, Sjöblom T, Nikkilä EA . Helsinki Heart Study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. N Engl J Med. 1987;317:1237-1245.
19. Report from the Committee of Principal Investigators. A cooperative trial in the primary prevention of ischaemic heart disease using clofibrate. Br Heart J. 1978;40:1069-1103.
20. Report from the Committee of Principal Investigators. WHO cooperative trial on primary prevention of ischaemic heart disease with clofibrate to lower serum cholesterol: final mortality follow-up. Lancet. 1984;2:600-604.
21. Heady JA, Morris JN, Oliver MF. WHO Clofibrate/Cholesterol Trial: clarifications. Lancet. 1992;340:1405-1406.
22. Coronary Drug Project Research Group. The findings leading to further modifications of its protocol with respect to dextrothyroxine. JAMA. 1972;220:996-1008.
23. Muldoon MF, Manuck SB, Mathews KA. Lowering cholesterol concentration and mortality: a quantitative review of primary prevention trials. BMJ. 1990;301:309-314.
24. Davey Smith G, Pekkanen J. Should there be a moratorium on the use of cholesterol lowering drugs? BMJ. 1992;304:431-434.
25. Davey Smith G, Song F, Sheldon TA. Cholesterol lowering and mortality: the importance of considering initial level of risk. BMJ. 1993;306:1367-1373.
26. Ravnskov U. Cholesterol lowering trials in coronary heart disease: frequency of citation and outcome. BMJ. 1992:305:15-19.
27. Cucherat M, Boissel J-P. Meta-analysis of results from clinical trials on prevention of coronary heart disease by lipid-lowering interventions. Clin Trials Meta-Anal. 1993;28:109-129.
28. Holme I. An analysis of randomized trials evaluating the effect of cholesterol reduction on total mortality and coronary heart disease incidence. Circulation. 1990;82:1916-1924.
29. Holme I. Meta-analysis of cholesterol reduction trials: coronary disease and mortality. Primary Cordiol. 1992;18:63-70.
30. Holme I. Relation of coronary heart disease incidence and total mortality to plasma cholesterol reduction in randomized trials: use of meta-analysis. Br Heart J. 1993;69(suppl):S42-S47.
31. Rossouw JE, Lewis B, Rifkind BM. The value of lowering cholesterol after myocardial infarction. N Engl J Med. 1990;323: 1112-1119.
32. Rossouw JE, Canner PL, Hulley SB. Deaths from injury, violence, and suicide in secondary prevention trials of cholesterol lowering. N Engl J Med. 1991;325:1813. Letter.
33. Law MR, Wald NJ, Thompson SG. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? BMJ. 1994;308:351-352.
34. Law MR, Thompson SG, Wald NJ. Assessing possible hazards of reducing serum cholesterol. BMJ. 1994;308:373-379.
35. McCullagh P, Nelder JA. Generalized Linear Models. 2nd ed. New York, NY: Chapman & Hill; 1989.
36. Greenland S, Salvan A. Bias in the one-step method for pooling study results. Stat Med. 1990;9:247-252.
37. Dorr AE, Gunderson K, Schneider JC, Spencer TW, Martin WB. Colestipol hydrochloride in hypercholesterolemic patients: effect on serum cholesterol and mortality. J Chronic Dis. 1978;31:5-14.
38. Dayton S, Pearce ML, Hashimoto S, Dixon WJ, Tomiyasu UA. A controlled clinical trial of a diet high in unsaturated fat in preventing complications of atherosclerosis. Circulation. 1969;40(suppl II):II-1-II-63.
39. Wilhelmsen L, Berglund G, Elmfeldt D, Tibblin G, Wedel H, Pennert K, Vedin A, Wilhelmsson C, Werkö L. The multifactor primary prevention trial in Göteborg, Sweden. Eur Heart J. 1986;7: 279-288.
40. Multiple Risk Factor Intervention Trial research group. Multiple Risk Factor Intervention Trial: risk factor changes and mortality results. JAMA. 1982;248:1465-1477.
41. Miettinen TA, Huttunen JK, Naukkarinen V. Multifactorial primary prevention of cardiovascular diseases in middle-aged men: risk factor changes, incidence, and mortality. JAMA. 1985;254: 2097-2102.
42. Hjerman I, Byre KV, Holme I, Leren P. Effect of diet and smoking on the incidence of coronary heart disease: report from the Oslo Study Group of a randomized trial of healthy men. Lancet. 1981;2: 1303-1310.
43. Buchwald H, Varco RL, Matts JP, Long JM, Fitch LL, Campbell GS, Pearce MB, Yellin AE, Edmiston WA, Smink RD, Sawin HS, Campos CT, Hansen BJ, Tuna N, Karnegis JN, Sanmarco ME, Amplatz K, Castaneda-Zuniga WR, Hunter DW, Bissett JK, Weber FJ, Stevenson JW, Leon AS, Chalmers TC, and the POSCH group. Report of the Program on the Surgical Control of Hyperlipidemias (POSCH): effect of partial ileal bypass surgery on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia. N Engl J Med. 1990;323:946-955.
44. Schoch HK. The U.S. Veterans Administration cardiology drug-lipid study: an interim report. In: Holmes WL, Carlson LA, Paoletti R, eds. Drugs Affecting Lipid Metabolism. New York, NY: Plenum Press; 1969:405-420.
45. Frick MH, Heinonen OP, Huttunen JK, Koskinen P, Manttari M, Manninen V. Efficacy of gemfibrozil in dyslipidaemic subjects with suspected heart disease: an ancillary study in the Helsinki Heart Study frame population. Ann Intern Med. 1993;25:41-45.
46. Research Committee of the Scottish Society of Physicians. Ischaemic heart disease: a secondary prevention trial using clofibrate. BMJ. 1971;4:775-784.
47. Coronary Drug Project Research Group. The coronary drug project: clofibrate and niacin in coronary heart disease. JAMA. 1975;231:360-381.
48. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W, for the Coronary Drug Project Research Group. Fifteen year mortality in coronary drug project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986;8:1245-1255.
49. Acheson J, Hutchinson EC. Controlled trial of clofibrate in cerebral vascular disease. Atherosclerosis. 1972;15:177-183.
50. Oliver MF, Boyd GS. Influence of reduction of serum lipids on prognosis of coronary heart disease: a five year study using oestrogen. Lancet. 1961;2:499-505.
51. Burr ML, Fehily AM, Gilbert JF, Rogers S, Holliday RM, Sweetnam PM, Elwood PC, Deadman NM. Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART). Lancet. 1989;2:757-761.
52. Woodhill JM, Palmer AJ, Leelarthaepin B, McGilchrist C, Blacket RB. Low fat, low cholesterol diet in secondary prevention of coronary heart disease. Adv Exp Med Biol. 1978;109:317-330.
53. Research Committee. Low-fat diet in myocardial infarction: a controlled trial. Lancet. 1965;2:501-504.
54. Rose GA, Thompson WB, Williams RT. Corn oil in treatment of ischemic heart disease. BMJ. 1965;1:1531-1533.
55. Research Committee to the Medical Research Council. Controlled trial of soyabean oil in myocardial infarction. Lancet. 1968;2: 693-700.
56. Leren P. The effect of plasma cholesterol lowering diet in male survivors of myocardial infarction: a controlled clinical trial. Acta Med Scand. 1966;suppl 466:1-92.
57. Brown G, Albers JJ, Fisher LD, Schaefer SM, Lin J-T, Kaplan C, Zhao X-Q, Besson BD, Fitzpatrick VF, Dodge HT. 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.
58. Watts GF, Lewis B, Brunt JNH, Lewis ES, Coltart DJ, Smith LR, Mann JL, Swan AV. 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.
59. Brensike JF, Levy RI, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarity DJ, Fisher MR, Friedman L, Friedewald W, Detre KM, Epstein SE. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984;69:313-324.
60. Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipolniacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987;257:3233-3240.
61. Sahni R, Maniet AR, Voci G, Banka VS. Prevention of restenosis by lovastatin after successful coronary angioplasty. Am Heart J. 1991;121:1600-1608.
62. Fail PS, Sahni RS, Maniet AR, Voci G, Banka VS. The long-term clinical efficacy of lovastatin therapy following successful coronary angioplasty. Clin Res. 1992;40:400A. Abstract.
63. Coronary Drug Project Research Group. The coronary drug project: initial findings leading to modification of its research protocol. JAMA. 1970;214:1303-1313.
64. Coronary Drug Project Research Group. The Coronary Drug Project: findings leading to discontinuation of the 2.5 mg/day estrogen group. JAMA. 1973;226:652-657.
65. Schucker B, Wittes JT, Santanello NC, Weber SJ, McGoldrick D, Donato K, Levy A, Rifkind BM. Change in cholesterol awareness and action: results from national physician and public surveys. Arch Intern Med. 1991;151:666-673.
66. Atkins D, Psaty BM, Koepsell TD, Longstreth WT Jr, Larson EB. Cholesterol reduction and the risk of stroke for men. Ann Intern Med. 1993;119:136-145.
67. 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.
68. Levin B. The saddlepoint correction in conditional logistic likelihood analysis. Biometrika. 1990;77:275-285.
69. Reid N. Saddlepoint methods and statistical inference. Stat Sci. 1988;3:213-238.
70. Flemington TR, Harrington DP. Counting Processes and Survival Analysis. New York, NY: John Wiley & Sons; 1991.
71. D'Agostino RB, Lee M-L, Belanger AJ, Cupples LA, Anderson K, Kannel WB. Relation of pooled logistic regression to time dependent Cox regression analysis: the Framingham Heart Study. Stat Med. 1990;9:1501-1515.
72. Berlin JA, Longnecker MP, Greenland S. Meta-analysis of epidemiologic dose-response data. Epidemiology. 1993;4:218-228.