Research Article| Volume 88, ISSUE 4, SUPPLEMENT 1, 36-40, August 16, 2001

Ongoing clinical trials of statins

  • Antonio M Gotto Jr
    Address for reprints: Antonio M. Gotto, Jr., MD, DPhil, c/o Mr. Jesse Jou, Weill Medical College of Cornell University, 445 East 69th Street, Olin Hall 205, New York, New York 10021
    Weill Medical College of Cornell University, New York, New York, USA
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      Lipid-lowering treatment with statins is effective for primary and secondary prevention of coronary artery disease in patients with either hypercholesterolemia or average cholesterol levels. Several clinical trials in progress will investigate the use of statins in entirely elderly or diabetic cohorts, and larger trials will continue to include significant numbers of these patients, as well as greater numbers of women. Additional clinical endpoint trials are assessing the potential benefits of lowering lipid levels to below currently recommended goals and of aggressive early statin treatment to prevent ischemic events in patients with stable coronary disease or acute coronary syndromes. These trials are expected to yield important data on the relation of lipid reduction to the prevention of coronary artery disease and on the potential for extending the use of statins.
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      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).
        Circulation. 1994; 89: 1329-1345
        • Scandinavian Simvastatin Survival Study Group
        Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease.
        Lancet. 1994; 344: 1383-1389
        • Shepherd J.
        • Cobbe S.M.
        • Ford I.
        • Isles C.G.
        • Lorimer A.R.
        • MacFarlane P.W.
        • McKillop J.H.
        • Packard C.J.
        • West of Scotland Coronary Prevention Study Group
        Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.
        N Engl J Med. 1995; 333: 1301-1307
        • Sacks F.M.
        • Pfeffer M.A.
        • Moyé L.A.
        • Rouleau J.L.
        • Rutherford J.D.
        • Cole T.G.
        • Brown L.
        • Warnica J.W.
        • Arnold J.M.O.
        • Wun C.-C.
        • Davis B.R.
        • Braunwald E.
        • Cholesterol and Recurrent Events Trial Investigators
        The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels.
        N Engl J Med. 1996; 335: 1001-1009
        • Downs J.R.
        • Clearfield M.
        • Weis S.
        • Whitney E.
        • Shapiro D.R.
        • Beere P.A.
        • Langendorfer A.
        • Stein E.A.
        • Kruyer W.
        • Gotto Jr, A.M.
        • AFCAPS/TexCAPS Research Group
        Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels.
        JAMA. 1998; 279: 1615-1622
        • The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group
        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. 1998; 339: 1349-1357
        • American Heart Association
        2001 Heart and Stroke Statistical Update. American Heart Association, Dallas2000
        • Shepherd J.
        • Blauw G.J.
        • Murphy M.B.
        • Cobbe S.M.
        • Bollen E.L.
        • Buckley B.M.
        • Ford I.
        • Jukema J.W.
        • Hyland M.
        • Gaw A.
        • et al.
        • PROSPER Study Group
        The design of a Prospective Study of Pravastatin in the Elderly at Risk (PROSPER).
        Am J Cardiol. 1999; 84: 1192-1197
        • MRC/BHF Heart Protection Study Collaborative Group
        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.
        Eur Heart J. 1999; 20: 725-741
        • American Diabetes Association
        Management of dyslipidemia in adults with diabetes.
        Diabetes Care. 2000; 23: 557-565
        • Kannel W.B.
        • McGee D.L.
        Diabetes and cardiovascular disease.
        JAMA. 1979; 241: 2035-2038
        • Abbot R.D.
        • Donahue R.P.
        • Kannel W.B.
        • Wilson P.W.
        The impact of diabetes on survival following myocardial infarction in men vs. women.
        JAMA. 1988; 260: 3456-3460
        • Pyörälä K.
        • De Backer G.
        • Graham I.
        • Poole-Wilson P.
        • Wood D.
        Prevention of coronary heart disease in clinical practice.
        Eur Heart J. 1994; 15: 1300-1331
        • Tikkanen M.J.
        • Laakso M.
        • Ilmonen M.
        • Helve E.
        • Kaarsalo E.
        • Kilkki E.
        • Saltevo J.
        • the study group
        Treatment of hypercholesterolemia and combined hyperlipidemia with simvastatin and gemfibrozil in patients with NIDDM.
        Diabetes Care. 1998; 21: 477-481
        • Jeck T.
        • Riesen W.F.
        • Keller U.
        Comparison of bezafibrate and simvastatin in the treatment of dyslipidaemia in patients with NIDDM.
        Diabet Med. 1998; 14: 564-570
        • Byers R.J.
        • Eddleston J.M.
        • Pearson R.C.
        • Bigley G.
        • McMahon R.F.
        The Women’s Ischemia Syndrome Evaluation (WISE) study.
        Crit Care Med. 1999; 27: 1787-1793
        • Davis B.R.
        • Cutler J.A.
        • Gordon D.J.
        • Furberg C.D.
        • Wright Jr, J.T.
        • Cushman W.C.
        • Grimm R.H.
        • LaRosa J.
        • Whelton P.K.
        • Perry H.M.
        • et al.
        • ALLHAT Research Group
        Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
        J Hypertens. 1996; 9: 342-360
        • The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group
        Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone.
        JAMA. 2000; 283: 1967-1975
      2. Executive Summary of the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).
        JAMA. 2001; 285: 2486-2497
        • Pedersen T.R.
        • Olsson A.G.
        • Færgeman O.
        • Kjekshus J.
        • Wedel H.
        • Berg K.
        • Wilhelmsen L.
        • Haghfelt T.
        • Thorgeirsson G.
        • Pyörälä K.
        • et al.
        • Scandinavian Simvastatin Survival Study Group
        Lipoprotein changes and reduction in the incidence of major coronary heart disease events in the Scandinavian Simvastatin Survival Study (4S).
        Circulation. 1998; 97: 1453-1460
        • Sacks F.M.
        • Moyé L.A.
        • Davis B.R.
        • Cole T.G.
        • Rouleau J.L.
        • Nash D.T.
        • Pfeffer M.A.
        • Braunwald E.
        Relationship between plasma LDL concentrations during treatment with pravastatin and recurrent coronary events in the Cholesterol and Recurrent Events trial.
        Circulation. 1998; 97: 1446-1452
      3. LaRosa JC, for the TNT Steering Committee. Effect of lowering LDL-C beyond currently recommended minimum targets: the Treating to New Targets (TNT) study. Abstract presented at the XIII International Symposium on Drugs Affecting Lipid Metabolism. Florence, Italy, May 30–June 3, 1998.

        • Andrews T.C.
        • Raby K.
        • Barry J.
        • Naimi C.L.
        • Allred E.
        • Ganz P.
        • Selwyn A.P.
        Effect of cholesterol reduction on myocardial ischemia in patients with coronary disease.
        Circulation. 1997; 95: 324-328
        • Pedersen T.R.
        • Kjekshus J.
        • Pyörälä K.
        • Olsson A.G.
        • Cook T.J.
        • Musliner T.A.
        • Tobert J.A.
        • Haghfelt T.
        Effect of simvastatin on ischemic signs and symptoms in the Scandinavian Simvastatin Survival Study (4S).
        J Am Coll Cardiol. 1998; 81: 333-335
        • Isaacsohn J.L.
        • Davidson M.H.
        • Hunninghake D.
        • Singer R.
        • McLain R.
        • Black D.M.
        Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE).
        Am J Cardiol. 2000; 86: 250-252