Original article| Volume 10, ISSUE 1, P33-39, May 1999

Efficacy and safety of atorvastatin and pravastatin in patients with hypercholesterolemia


      This 1-year, double-blind, active-controlled, multicenter study compared the efficacy and safety of atorvastatin to pravastatin and evaluated their ability to achieve target low-density lipoprotein cholesterol (LDL-C) levels in patients with hypercholesterolemia. Patients were stratified to risk factor groups based upon European Atherosclerosis Society (EAS) guidelines before randomization to atorvastatin 10 or 20 mg or pravastatin 20 or 40 mg once daily. Target LDL-C levels for patients with mild/moderate risk and severe risk were <130 mg/dl (3.4 mmol/l) and <115 mg/dl (3.0 mmol/l), respectively. If needed to achieve target levels both drugs were uptitrated within the approved dose range. Mean changes from LDL-C levels were 39% for atorvastatin patients compared to 29% for pravastatin-treated patients (p<0.0001). The number of patient responders (those reaching LDL-C goals) was higher (p<0.0001) for atorvastatin patients (91% at any study visit and 51% at the last study visit) than for pravastatin patients (48% and 20%, respectively). The daily atorvastatin dose used by most patients after the titration phase was 10 mg and the respective pravastatin dose was 40 mg. Both drugs were well-tolerated and had similar adverse event profiles. Atorvastatin, in the approved dose range, will allow a greater number of patients to reach established LDL-C treatment goals with single drug therapy.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to European Journal of Internal Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Levy R.I
        Review: declining mortality in coronary heart disease.
        Arteriosclerosis. 1981; 1: 312-325
      1. Lipid Research Clinics Program, The lipid research clinics coronary primary prevention trial results: I. Reduction in incidence of coronary heart disease, J. Am. Med. Assoc. 151 (1984) 351–364.

      2. 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, J. Am. Med. Assoc. 151 (1984) 365–374.

        • Brown G
        • Albers J.J
        • Fisher L.D
        • 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
        • Stewart B.F
        • Brown B.G
        • Zhao X
        • et al.
        Benefits of lipid-lowering therapy in men with elevated apolipoprotein B are not confined to those with very high low density lipoprotein cholesterol.
        J. Am. Coll. Cardiol. 1994; 23: 899-906
      3. Prevention of coronary heart disease: scientific background and new clinical guidelines, Recommendations of the European Atherosclerosis Society prepared by the International Task Force for prevention of coronary heart disease, Nutr. Metab. Cardiovasc. Dis. 2 (1992) 113–156.

      4. 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), J. Am. Med. Assoc. 269 (1993) 3015–3023.

        • Illingworth E.R
        New horizons in combination drug therapy for hypercholesterolemia.
        Cardiology. 1989; 76: 83-100
        • Nawrocki J.W
        • Weiss S.R
        • Davidson M.H
        • et al.
        Reduction of LDL-cholesterol by 25% to 60% in patients with primary hypercholesterolemia by atorvastatin, a new HMG-CoA reductase inhibitor.
        Arterioscler. Thromb. Vasc. Biol. 1995; 15: 678-682
        • Jones P
        • Kafonek S
        • Laurora I
        • Hunninghake D
        • Curves Investigators
        Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study).
        Am. J. Cardiol. 1998; 81: 582-587
        • Bakker-Arkema R.G
        • Davidson M.H
        • Goldstein R.J
        • et al.
        Efficacy and safety of a new HMG-CoA reductase inhibitor in patients with hypertriglyceridemia.
        J. Am. Med. Assoc. 1996; 275: 128-133
        • Black D.M
        • Bakker-Arkema R.G
        • Nawrocki J.W
        An overview of the clinical safety profile of atorvastatin (Lipitor), a new HMG-CoA reductase inhibitor.
        Arch. Int. Med. 1998; 158: 577-584
      5. Bristol-Myers Squibb Pravachol® prescribing information, in: Physicians' Desk Reference, Medical Economics Data, A Division of Medical Economics, Montvale, NJ, 1998, pp. 808–811.

        • Bradford R.H
        • Shear C.L
        • Chremos A.N
        • 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: 43-49
        • Hunninghake D.B
        • Knopp R.H
        • Schonfeld G
        • et al.
        Efficacy and safety of pravastatin in patients with primary hypercholesterolemia: I. A dose–response study.
        Atherosclerosis. 1990; 85: 81-89
        • Jungnickel P.W
        • Cantral K.A
        • Maloley P.A
        Pravastatin: a new drug for the treatment of hypercholesterolemia.
        Clin. Pharm. 1992; 11: 677-689
        • Jacobson T.A
        • Chin M.M
        • Fromell G.J
        • et al.
        Fluvastatin with or without niacin for hypercholesterolemia.
        Am. J. Cardiol. 1994; 74: 149-154
        • Banga J.D
        • Jacotot B
        • Pfister P
        • et al.
        Long-term treatment of hypercholesterolemia with fluvastatin: a 52-week multicenter safety and efficacy study.
        Am. J. Med. 1994; 96: 87S-93S
        • Henwood J.M
        • Heel R.C
        Lovastatin—A preliminary review of its pharmacodynamic properties and therapeutic use in hyperlipidemia.
        Drugs. 1988; 36: 429-454
        • Kostner G
        • Gavish D
        • Leopold B
        • et al.
        HMG-CoA reductase inhibitors lower LDL cholesterol without reducing Lp(a) levels.
        Circulation. 1989; 80: 1313-1319
        • 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/l (200 to 300 mg/dl) plus two additional atherosclerotic risk factors.
        Am. J. Cardiol. 1993; 72: 1031-1037
        • Pitt B
        • Mancini G.B.J
        • Ellis S.G
        • et al.
        Pravastatin limitation of atherosclerosis in the coronary arteries (PLAC-I): reduction in atherosclerosis progression and clinical events.
        J. Am. Coll. Cardiol. 1995; 26: 1133-1139
        • Crouse J.R
        • Byington R.P
        • Bond M.G
        • et al.
        Pravastatin, lipids, and atherosclerosis in the carotid arteries (PLAC-II).
        Am. J. Cardiol. 1995; 75: 455-459
        • Jukema J.W
        • Bruschke V.G
        • van Boven A.J
        • et al.
        Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease and regression of coronary artery disease in symptomatic men with normal to moderately elevated serum cholesterol levels.
        Circulation. 1995; 91: 2528-2540
        • Shepherd J
        • Cobbe S.M
        • Ford I
        • et al.
        Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.
        N. Engl. J. Med. 1995; 333: 1301-1307
        • Salonen R
        • Nyyssönen K
        • Porkkala E
        • et al.
        Kuopio atherosclerosis prevention study (KAPS): a population-based primary preventive trial of the effect of LDL lowering on atherosclerotic progression in carotid and femoral arteries.
        Circulation. 1995; 92: 1758-1764
        • Frick M.H
        • Elo O
        • Haapa K
        • et al.
        Helsinki Heart Study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia.
        N. Engl. J. Med. 1987; 317: 1237-1245
        • Carlson L.A
        • Bottiger L.E
        Ischemic heart disease in relation to fasting values of plasma triglycerides and cholesterol. Stockholm prospective study.
        Lancet. 1972; 1: 865-868
        • Scandinavian Simvastatin Study Group
        Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S).
        Lancet. 1994; 344: 1383-1389
        • The Long-term intervention with pravastatin in ischemic 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
        • Sacks P.M
        • Pfeffer M.A
        • Moye L.A
        • et al.
        For the 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
        • Watts G.F
        • Burke V
        Lipid-lowering trials in the primary and secondary prevention of coronary heart disease: new evidence, implications and outstanding issues.
        Curr. Opin. Lipidology. 1996; 7: 341-355
        • Hunninghake D.B
        HMG-CoA reductase inhibitors.
        Curr. Opin. Lipidology. 1992; 3: 22-28