An economic analysis of the Atorvastatin Comparative Cholesterol Efficacy and Safety Study (ACCESS).
BACKGROUND
The objective of the Atorvastatin Comparative Cholesterol Efficacy and Safety Study (ACCESS) was to compare the efficacy and safety of the five 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors in a randomised, controlled, yet large-scale study. ACCESS also produced data that permitted comparative analysis of the cost to achieve National Cholesterol Education Panel (NCEP) II low density lipoprotein-cholesterol (LDL-C) targets.


METHODS
A 54-week, multicentre, open-label, randomised, parallel-arm, active-control study in men and women with or without documented coronary heart disease or peripheral vascular disease. Data included medication use, clinic visits, adverse events, LDL-C and other laboratory measures. Analyses of resource use and cost are reported from a third-party payer perspective.


METHODS
Patients were randomly assigned to receive one of the following treatments: atorvastatin (10-80 mg/day); fluvastatin (20-40 mg/day, or 40 mg twice daily); lovastatin (20-40 mg/day, or 40 mg twice daily); pravastatin (10-40 mg/day); or simvastatin (10-40 mg/day). Patients were started at the lowest available dose and titrated to higher doses at 6-week intervals until they achieved the NCEP II LDL-C target or reached the highest available dose of medication.


METHODS
A total of 153 centres enrolled 3887 patients: atorvastatin (n = 1944); fluvastatin (n = 493); lovastatin (n = 494); pravastatin (n = 478); and simvastatin (n = 478). Inclusion criteria included LDL-C >or= 30 mg/dL higher than NCEP II LDL-C target (stratified by risk factors), fasting triglyceride values < 400 mg/dL, and a confirmed negative serum pregnancy test. Known hypersensitivity to statins, use of prohibited medications, uncontrolled diabetes, acute liver disease and age > 80 years or < 18 years were among the exclusion criteria.


RESULTS
Mean total treatment costs to reach LDL-C targets for patients receiving atorvastatin (US dollars 683.37 in 2001) were significantly less than mean total treatment costs for patients receiving fluvastatin (difference = US dollars 211.35, p < 0.01), lovastatin (US dollars 607.96, p < 0.01), pravastatin (US dollars 424.60, p < 0.01) and simvastatin (US dollars 95.74, p < 0.01). Results were robust to sensitivity analyses using alternative definitions of the patient population (randomised, intent-to-treat, completers) and cost measures (50th percentile charges, 95th percentile charges, Medicare prices).


CONCLUSIONS
Compared with the other statins studied, atorvastatin was associated with the lowest resource use and costs when used to treat patients to their NCEP II LDL-C targets. Atorvastatin was also associated with the highest percentage of patients achieving their desired clinical outcomes. Therefore, in cost-effectiveness terms, it dominated the four other statins.
Smith
Dean G
DG
Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan 48109-2029, USA. deans@umich.edu
McBurney
Christopher R
CR
D000328:Adult; D000368:Aged; D000069059:Atorvastatin; D008078:Cholesterol, LDL / Q000097:blood; D004305:Dose-Response Relationship, Drug; D005229:Fatty Acids, Monounsaturated / Q000191:economics / Q000627:therapeutic use; D005260:Female; D000077340:Fluvastatin; D006538:Heptanoic Acids / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy / Q000191:economics; D007211:Indoles / Q000191:economics / Q000627:therapeutic use; D008148:Lovastatin / Q000191:economics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000191:economics / Q000627:therapeutic use; D011758:Pyrroles / Q000191:economics* / Q000627:therapeutic use*; D012307:Risk Factors; D019821:Simvastatin / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome
D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D011758:Pyrroles; D000077340:Fluvastatin; D008148:Lovastatin; D000069059:Atorvastatin; D019821:Simvastatin; D017035:Pravastatin