MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: A randomised placebo-controlled trial

Lancet

Volumn 361, Issue 9374, 2003, Pages 2005-2016

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

HYPOCHOLESTEROLEMIC AGENT; PLACEBO; SIMVASTATIN;

ADULT; AGED; ARTICLE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DIABETES MELLITUS; HEART PROTECTION; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; PROBABILITY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; REDUCTION; REVASCULARIZATION; RISK FACTOR; STROKE;

EID: 0037840242     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(03)13636-7     Document Type: Article

References (46)

1. King H., Aubert R.E., Herman W.H. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 21:1998;1414-1431.
2. Garcia M.J., McNamara P.M., Gordon T., Kannell W.B. Morbidity and mortality in diabetics in the Framingham population: sixteen year follow-up study. Diabetes. 23:1974;105-111.
3. Panzram G. Mortality and survival in type 2 (non-insulin-dependent) diabetes mellitus. Diabetologia. 30:1987;123-131.
4. Haffner S.M., Lehto S., Rönnemaa T., Pyörälä K., Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 339:1998;229-234.
5. Pyörälä K., Laakso M., Uusitupa M. Diabetes and atherosclerosis: an epidemiologic view. Diabetes Metab Rev. 3:1987;463-524.
6. UK Prospective Diabetes Study 27: plasma lipids and lipoproteins at diagnosis of NIDDM by age and sex. Diabetes Care. 20:1997;1683-1687.
7. Yeo K.R., Yeo W.W. Lipid lowering in patients with diabetes mellitus: what coronary heart disease risk threshold should be used? Heart. 87:2002;423-427.
8. Arday D.R., Fleming B.B., Keller D.K., et al. Variation in diabetes care among states: do patient characteristics matter? Diabetes Care. 25:2002;2230-2237.
9. Department of Health. National Service Framework for diabetes: standards. http://www.doh.gov.uk/nsf/diabetes/index.htm (accessed May 29, 2003).
10. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 25:2002;S33-S49.
11. Jacobs D., Blackburn H., Higgins M., et al. Report of the conference on low blood cholesterol: mortality associations. Circulation. 86:1992;1046-1060.
12. Stamler J., Vaccaro O., Neaton J.D., Wentworth D. Diabetes, other risk factors and 12-year cardiovascular mortality for men screened in the multiple risk factor intervention trial. Diabetes Care. 16:1993;434-444.
13. Chen J., Campbell T.C., Li J., Peto R. Diet, life-style and mortality in China. 1990;Oxford University Press, Oxford. updated on http://www.ctsu.ox.ac.uk.
14. 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. BMJ. 303:1991;276-282.
15. Szatrowski T.P., Peterson A.V., Shimizu Y., et al. Serum cholesterol levels, other risk factors, and cardiovascular disease in a Japanese cohort. J Chronic Dis. 7:1984;569-584.
16. Turner R.C., Millns H., Neil H.A.W., et al. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom prospective diabetes study (UKPDS: 23). BMJ. 316:1998;823-828.
17. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 344:1994;1383-1389.
18. Sacks F.M., Pfeffer M.A., Moye L.A., et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 335:1996;1001-1009.
19. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. N Engl J Med. 336:1997;153-162.
20. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 339:1998;1349-1357.
21. Pyörälä K., Pedersen T.R., Kjekshus J., Faergeman O., Olsson A.G., Thorgeirsson G. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. Diabetes Care. 20:1997;614-620.
22. Goldberg R.B., Mellies M.J., Sacks F.M., et al. Cardiovascular events and their reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction survivors with average cholesterol levels: subgroup analyses in the Cholesterol and Recurrent Events (CARE) trial. Circulation. 98:1998;2513-2519.
23. Armitage J., Collins R. Need for large scale randomised evidence about lowering LDL cholesterol in people with diabetes mellitus: MRC/BHF heart protection study and other major trials. Heart. 84:2000;357-360.
24. Shepherd J., Cobbe S.M., Ford I., et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 333:1995;1301-1307.
25. Downs J.R., Clearfield M., Weis S., et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. JAMA. 279:1998;1615-1622.
26. MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience. Eur Heart J. 20:1999;725-741.
27. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 360:2002;7-22.
28. Prior M.J., Prout T., Miller D., Ewart R., Kumar D. C-peptide and the classification of diabetes mellitus patients in the Early Treatment Diabetic Retinopathy Study: report number 6. Ann Epidemiol. 3:1993;9-17.
29. MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20 536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 360:2002;23-33.
30. Hamwi A., Schweiger C.R., Veitl M., Schmid R. Quantitative measurement of HbA1c by an immunoturbidimetric assay compared to a standard HPLC method. Am J Clin Pathol. 104:1995;89-95.
31. Peto R., Pike M.C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient, I: introduction and design. Br J Cancer. 34:1976;585-612.
32. Peto R., Pike M.C., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient, II: analysis and examples. Br J Cancer. 35:1977;1-39.
33. Pocock S.J., Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 31:1975;103-115.
34. Levey A.S., Bosch J.P., Lewis J.B., Greene T., Rogers N., Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Ann Intern Med. 130:1999;461-470.
35. Levey A.S., Greene T., Kusek J.W., Beck G.J. MDRD Study Group. A simplified equation to predict glomerular filtration rate from serum creatinine. J Am Soc Nephrol. 11:2000;155A. abstr.
36. Freeman D.J., Norrie J., Sattar N., et al. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation. 103:2001;357-362.
37. Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: the Antihypertensive and Lipid-Lowering Treatment to prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 288:2002;2998-3007.
38. Sever P.S., Dahlöf B., Poulter N.R., et al. Prevention of coronary and stroke events with atorvastatin in hypertensive subjects who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial - Lipid lowering arm (ASCOT-LLA)): a multicentre randomised controlled trial. Lancet. 361:2003;1149-1158.
39. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA. 285:2001;2486-2497.
40. McIntosh A, Hutchinson A, Feder G, et al. Clinical guidelines for type 2 diabetes: lipids management. http://www.shef.ac.uk/guidelines/lipid/lipids.pdf (accessed May 9, 2003).
41. Management of dyslipidemia in adults with diabetes. Diabetes Care. 26:2003;S83-S86.
42. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 317:1998;703-713.
43. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 342:2000;145-153.
44. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 352:1998;837-853.
45. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Lancet. 356:2000;1955-1964.
46. Wilson K., Gibson N., Willan K., Cook D. Effect of smoking cessation on mortality after myocardial infarction: meta-analysis of cohort studies. Arch Intern Med. 160:2000;939-944.