Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin in subclinical atherosclerosis--the rationale and methodology of the METEOR study.
BACKGROUND
Increased carotid intima media thickness (IMT) is associated with established coronary heart disease (CHD) and is a marker of atherosclerosis. Statins are an effective treatment for dyslipidaemia, and have been shown to retard progression or promote carotid IMT regression in patients at high risk of CHD. Rosuvastatin is a highly efficacious statin, and the Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) study is designed to assess the impact of rosuvastatin on carotid IMT progression in low risk subjects with signs of subclinical atherosclerosis.


METHODS
In this randomised, parallel-group study, asymptomatic subjects at low risk of cardiovascular disease, but with evidence of atherosclerosis (defined as carotid IMT >or=1.2 mm and <3.5 mm), will receive rosuvastatin (40 mg/day) or placebo for 104 weeks. The study will enrol 840 European and US subjects randomised 5:2 between rosuvastatin and placebo. The primary end point will be the change in carotid IMT from baseline to study end, measured using B-mode ultrasonography. Other efficacy end points include changes in the serum lipid profile and C-reactive protein. Safety parameters will also be assessed.


CONCLUSIONS
The METEOR study will evaluate whether long-term rosuvastatin treatment promotes regression, or slows progression, of subclinical atherosclerosis in asymptomatic subjects at low risk of cardiovascular disease.
Crouse
John Robert
JR
Department of Medicine, Section on Endocrinology/Metabolism, Wake Forest University School of Medicine, Medical Center Blvd.,Winston-Salem, NC 27157, USA. jrcrouse@wfubmc.edu
Grobbee
Diederick E
DE
O'Leary
Daniel H
DH
Bots
Michiel L
ML
Evans
Gregory W
GW
Palmer
Mike K
MK
Riley
Ward A
WA
Raichlen
Joel S
JS
D001161:Arteriosclerosis / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control*; D002097:C-Reactive Protein / Q000737:chemistry / Q000378:metabolism; D016893:Carotid Stenosis / Q000175:diagnosis / Q000473:pathology / Q000503:physiopathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005464:Fluorobenzenes / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D050356:Lipid Metabolism; D008055:Lipids / Q000737:chemistry; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D011446:Prospective Studies; D011743:Pyrimidines / Q000494:pharmacology / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors; D017539:Tunica Intima / Q000033:anatomy & histology* / Q000187:drug effects* / Q000473:pathology; D017540:Tunica Media / Q000033:anatomy & histology* / Q000187:drug effects* / Q000473:pathology; D014463:Ultrasonography / Q000379:methods
D005464:Fluorobenzenes; D008055:Lipids; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D002097:C-Reactive Protein