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Randomized Comparison of the Efficacy and Safety of Cerivastatin and Pravastatin in 1030 Hypercholesterolemic Patients

      OBJECTIVE

      To determine the relative efficacy and safety of cerivastatin and pravastatin in patients with type II hypercholesterolemia.

      PATIENTS AND METHODS

      In this prospective, doubleblind, parallel-group study, hypercholesterolemic patients were randomized to treatment with cerivastatin, 0.3 mg (n=250) or 0.4 mg (n=258), or pravastatin, 20 mg (n=266) or 40 mg (n=256), for 8 weeks.

      RESULTS

      Cerivastatin, 0.3 mg, was significantly more effective than pravastatin, 20 mg, in reducing low-density lipoprotein (LDL) cholesterol from baseline (-29.6% vs -26.8%; P=.008). Cerivastatin, 0.4 mg, was significantly more effective than pravastatin, 40 mg, in reducing LDL cholesterol (-34.2% vs -30.3%; P<.001). A larger proportion of cerivastatin-treated patients had greater than 40% reductions in LDL cholesterol than those receiving pravastatin (11.1% vs 6.0%). The percentage of patients who achieved the National Cholesterol Education Program (NCEP) target was 71.3% with cerivastatin, 0.3 mg, compared with 67.5% with pravastatin, 20 mg, and 74.0% with cerivastatin, 0.4 mg, compared with 71.1% with pravstatin, 40 mg (no significant difference). Cerivastatin, 0.3 mg, reduced total cholesterol to a greater extent than did pravastatin, 20 mg (P<.03). Both agents reduced triglycerides and increased high-density lipoprotein cholesterol to a similar degree (no significant differences). Cerivastatin and pravastatin were well tolerated.

      CONCLUSIONS

      Cerivastatin, 0.3 mg and 0.4 mg, showed greater efficacy than pravastatin, 20 mg and 40 mg, respectively, in lowering LDL cholesterol. Cerivastatin is safe and effective for patients with hypercholesterolemia who require aggressive LDL cholesterol lowering to achieve NCEP-recommended targets.
      ALT (alanine aminotransferase), AST (aspartate aminotransferase), CHD (coronary heart disease), CK (creatine phosphokinase), ECG (electrocardiography), HDL (high density lipoprotein), HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A), LDL (low-density lipoprotein), NCEP (National Cholesterol Education Program), PVD (peripheral arterial vascular disease), ULN (upper limit of normal)
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      REFERENCES

        • Castelli WP
        • Garrison RJ
        • Wilson PW
        • Abbott RD
        • Kalousdian S
        • Kannel WB
        Incidence of coronary heart disease and Lipoprotein cholesterol levels: the Framingham Study.
        JAMA. 1986; 256: 2835-2838
        • Neaton JD
        • Blackburn H
        • Jacobs D
        • et al.
        Multiple Risk Factor Intervention Trial Research Group. Serum cholesterol level and mortality findings for men screened in the Multiple Risk Factor Intervention Trial.
        Arch Intern Med. 1992; 152: 1490-1500
      1. The Lipid Research Clinics Coronary Primary Prevention Trial results, I: reduction in incidence of coronary heart disease.
        JAMA. 1984; 251: 351-364
        • Frick MH
        • Elo O
        • Haapa K
        • 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: I237-1245
      2. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S).
        Lancet. 1994; 344: 1383-1389
        • Shepherd J
        • Cobbe SM
        • Ford I
        • et al.
        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 FM
        • Pfeffer MA
        • Moye LA
        • et al.
        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
        • Blankenhorn DH
        • Azen SP
        • Kramsch DM
        • et al.
        MARS Research Group. Coronary angiographic changes with lovastatin therapy: the Monitored Atherosclerosis Regression Study (MARS).
        Ann Intern Med. 1993; 119: 969-976
        • Jukema JW
        • Bruschke AV
        • van Bovcn AJ
        • REGRESS Study Group
        • et al.
        Effects of lipid lowering by pravastatin on progression and regression of coronary artery disease in symptomatic men with normal to moderately elevated serum cholesterol levels: the Regression Growth Evaluation Statin Study (REGRESS).
        Circulation. 1995; 91: 2528-2540
        • Yee HS
        • Fong NT
        Atorvastatin in the treatment of primary hypercholsterolemia and mixed dyslipidemias.
        Ann Pharmacother. 1998; 32: 1030-1043
        • Bischoff H
        • Angerbauer R
        • Bender J
        • et al.
        Cerivastatin: pharmacology of a novel synthetic and highly active HMG-CoA reductase inhibitor.
        Atherosclerosis. 1997; 135: 119-130
        • Davignon J
        • Hanefeld M
        • Nakaya N
        • Hunninghake DB
        • Insull Jr, W
        • Ose L
        Clinical efficacy and safety of cerivastatin: summary of pivotal phase Ilb/III studies.
        Am J Cardiol. 1998; 82: 32J-39J
        • Stein E
        Cerivastatin in primary hyperlipidemia: a multicenter analysis of efficacy and safety.
        Am J Cardiol. 1998; 82: 40J-46J
        • Osc L
        • Luurila O
        • Eriksson J
        • Olsson A
        • Lithell H
        • Widgren B
        • Cerivastatin Study Group
        Efficacy and safety of cerivastatin, 0.2 mg and 0.4 mg, in patients with primary hypercholesterolaemia: a multinational, randomised, double-blind study.
        Curr Med Res Opin. 1999; 15: 228-240
        • Farnier M
        • Cerivastatin Study Group
        Cerivastatin in the treatment of mixed hyperlipidemia: the RIGHT study.
        Am J Cardiol. 1998; 82: 47J-51J
        • 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
        • 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/liter (200 to 300 mg/dl) plus two additional atherosclerotic risk factors.
        Am J Cardiol. 1993; 72: 1031-1037
        • Jones PH
        • Farmer JA
        • Cressman MD
        • et al.
        Once-daily pravastatin in patients with primary hypercholesterolemia: a dose-response study.
        Clin Cardiol. 1991; 14: 146-151
        • Crepaldi G
        • Baggio G
        • Area M
        • et al.
        Pravastatin vs gemfibrozil in the treatment of primary hypercholesterolemia: the Italian Multi-center Pravastatin Study I.
        Arch Intern Med. 1991; 151: 146-152
        • Krone W
        • Schmage N
        • Breuer H-W
        Comparison of long-term efficacy and safety of cerivastatin versus pravastatin in primary hypercholesterolaemia.
        J Clin Res. 1999; 2: 141-153
        • Stein E
        Cerivastatin in primary hyperlipidemia—a multicenter analysis of efficacy and safety.
        Atherosclerosis. 1998; 139: S15-S22
        • Roberts WC
        The rule of 5 and the rule of 7 in lipid-lowering by statin drugs [editorial].
        Am J Cardiol. 1997; 80: 106-107
        • Jacobson TA
        • Chin MM
        • Curry CL
        • et al.
        Efficacy and safety of pravastatin in African Americans with primary hypercholesterolemia.
        Arch Intern Med. 1995; 155: 1900-1906
        • McPherson R
        • Bedard J
        • Connelly P
        • et al.
        Comparison of the short-term efficacy and tolerability of lovastatin and pravastatin in the management of primary hypercholesterolemia.
        Clin Ther. 1992; 14: 276-291
        • Milani M
        • Cimminiello C
        • Merlo B
        • Lorena M
        • Arpaia G
        • Bonfardeci G
        Effects of fluvastatin and pravastatin on lipid profiles and thromboxane production in type IIa hypercholcsterolemia.
        Am J Cardiol. 1995; 76: 51A-53A
        • Dobs AS
        • Prasad M
        • Goldberg A
        • Guccione M
        • Hoover DR
        Changes in serum lipoprotein(a) in hyperlipidemic subjects under going long-term treatment with lipid-lowering drugs.
        Cardiovasc Drugs Ther. 1995; 9: 677-684