Preventive CardiologyComparative Dose Efficacy Study of Atorvastatin Versus Simvastatin, Pravastatin, Lovastatin, and Fluvastatin in Patients With Hypercholesterolemia (The CURVES Study) fn1
Section snippets
Study Design:
This study was a multicenter, open-label, randomized, parallel-group, 8-week comparative study evaluating the efficacy of once-daily doses of atorvastatin 10, 20, 40, and 80 mg compared with once-daily doses of simvastatin 10, 20, and 40 mg, pravastatin 10, 20, and 40 mg, lovastatin 20 and 40 mg, and fluvastatin 20 and 40 mg, and twice daily doses of lovastatin 40 mg (80 mg total daily dose). Male and female patients 18 to 80 years old with plasma LDL cholesterol concentrations ≥160 mg/dl (4.2
Patient Characteristics:
Of the 534 patients randomized to treatment, 518 patients completed the study. Sixteen patients (3%) withdrew before the end of the study: 8 because of adverse events, 4 for personal reasons, and 4 who were lost to follow-up. The intent-to-treat analysis included 522 patients who provided post-treatment efficacy data. Fifty-nine percent of patients (307) were men and 41% (215) were women; 90% (469) were white. Mean age was 55 years (range 20 to 80), and 17% of patients had established CAD.
Effects on Serum Lipids:
Mean
Discussion
The CURVES study is the first trial to compare the lipid-lowering efficacy of all marketed HMG-CoA reductase inhibitors, including the recently approved synthetic HMG-CoA reductase, atorvastatin, across their dose ranges. An open-label design was chosen for this study because of the impracticality of blinding 15 treatment arms. Efficacy end points were based on objective laboratory measurements.
Atorvastatin 10, 20, and 40 mg produced greater (p ≤0.01) reductions in total and LDL cholesterol
Acknowledgements
Acknowledgment:
We acknowledge and thank Boston Biostatistics Inc., Framingham, Massachusetts, for their support and efforts related to the conduct of the study and the data analysis.
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This study was supported by Parke-Davis, Division of Warner Lambert Company, Morris Plains, New Jersey. Manuscript received August 20, 1997; revised manuscript received and accepted November 24, 1997.
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See Appendix Afor list of CURVES investigators.