Document Detail

Design and rationale of the ARBITER trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol)--a randomized trial comparing the effects of atorvastatin and pravastatin on carotid artery intima-media thickness.
MedLine Citation:
PMID:  11231429     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: As a class, statins are remarkably effective in reducing low-density lipoprotein (LDL) cholesterol, and several of these drugs have now been shown to reduce coronary heart disease morbidity and mortality. However, several important controversies in the use of statins remain to be answered by clinical trials. For example, it is controversial whether marked cholesterol reduction to levels below 100 mg/dL would further reduce the incidence of coronary heart disease. Furthermore, concerns about differences among statins for nonlipid effects has raised the concern that the assumption of a class effect is premature until head-to-head clinical trials are completed. METHODS: Arterial Biology for the Investigation for the Treatment Effects of Reducing Cholesterol (ARBITER) is a single-center, randomized, active-controlled study comparing the efficacy of high-dose atorvastatin (80 mg/d) and pravastatin (40 mg/d) in patients being treated for either the primary or secondary prevention of coronary heart disease. This trial will enroll up to 200 patients for the primary end point of the mean change in intima-media thickness of the common carotid artery. This effect will be evaluated over a treatment duration of 12 months. Secondary end points include the effects of statin therapy on inflammatory and hemostatic markers (C-reactive protein and fibrinogen). CONCLUSION: ARBITER will provide important data on the role of marked LDL reduction and the "class effect" theory of statin therapy in cardiovascular medicine.
T T Markwood; S M Kent; L C Coyle; P J Flaherty; P G O'Malley; A J Taylor
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  American heart journal     Volume:  141     ISSN:  0002-8703     ISO Abbreviation:  Am. Heart J.     Publication Date:  2001 Mar 
Date Detail:
Created Date:  2001-03-20     Completed Date:  2001-04-19     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  342-7     Citation Subset:  AIM; IM    
Cardiology and General Internal Medicine Services, Department of Medicine, Walter Reed Army Medical Center, Washington, DC 20307-5001, USA.
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MeSH Terms
Carotid Artery, Common / drug effects,  pathology*
Cholesterol, LDL / analysis
Coronary Disease / drug therapy,  pathology*
Heptanoic Acids / pharmacology*,  therapeutic use
Hydroxymethylglutaryl CoA Reductases / pharmacology*,  therapeutic use
Pravastatin / pharmacology*,  therapeutic use
Pyrroles / pharmacology*,  therapeutic use
Randomized Controlled Trials as Topic
Research Design
Tunica Intima / drug effects,  pathology*
Tunica Media / drug effects,  pathology*
Reg. No./Substance:
0/Cholesterol, LDL; 0/Heptanoic Acids; 0/Pyrroles; 110862-48-1/atorvastatin; 81093-37-0/Pravastatin; EC 1.1.1.-/Hydroxymethylglutaryl CoA Reductases

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