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The METEOR Trial

John R. Crouse III, MD; Joel S. Raichlen, MD; Ward A. Riley, PhD; Gregory W. Evans, MA; Mike K. Palmer, PhD; Daniel H. O’Leary, MD; Diederick E. Grobbee, MD, PhD; Michiel L. Bots, MD, PhD; for the METEOR Study Group

JAMA. 2007;297:(doi:10.1001/jama.297.12.1344).

Context  Atherosclerosis is often advanced before symptoms appear and it is not clear whether treatment is beneficial in middle-aged individuals with a low Framingham risk score (FRS) and mild to moderate subclinical atherosclerosis.

Objective  To assess whether statin therapy could slow progression and/or cause regression of carotid intima-media thickness (CIMT) over 2 years.

Design, Setting, and Participants  Randomized, double-blind, placebo-controlled study (Measuring Effects on Intima-Media Thickness: an Evaluation of Rosuvastatin [METEOR]) of 984 individuals, with either age (mean, 57 years) as the only coronary heart disease risk factor or a 10-year FRS of less than 10%, modest CIMT thickening (1.2-<3.5 mm), and elevated LDL cholesterol (mean, 154 mg/dL); conducted at 61 primary care centers in the United States and Europe between August 2002 and May 2006.

Intervention  Participants received either a 40-mg dose of rosuvastatin or placebo.

Main Outcome Measures  Rate of change in maximum CIMT (assessed with B-mode ultrasound) for 12 carotid sites; changes in maximum CIMT of the common carotid artery, carotid bulb, and internal carotid artery sites and in mean CIMT of the common carotid artery sites. CIMT regression was assessed in the rosuvastatin group only.

Results  Among participants in the rosuvastatin group, the mean (SD) baseline LDL cholesterol level of 155 (24.1) mg/dL declined to 78 (27.5) mg/dL, a mean reduction of 49% (P<.001 vs placebo group). The change in maximum CIMT for the 12 carotid sites was –0.0014 (95% CI, –0.0041 to 0.0014) mm/y for the rosuvastatin group vs 0.0131 (95% CI, 0.0087-0.0174) mm/y for the placebo group (P<.001). The change in maximum CIMT for the rosuvastatin group was –0.0038 (95% CI, –0.0064 to –0.0013) mm/y for the common carotid artery sites (P<.001), –0.0040 (95% CI, –0.0090 to 0.0010) mm/y for the carotid bulb sites (P<.001), and 0.0039 (95% CI, –0.0009 to 0.0088) mm/y for the internal carotid artery sites (P = .02). The change in mean CIMT for the rosuvastatin group for the common carotid artery sites was 0.0004 (95% CI, –0.0011 to 0.0019) mm/y (P<.001). All P values are vs placebo group. Overall, rosuvastatin was well tolerated with infrequent serious adverse cardiovascular events (6 participants [0.86%] had 8 events [1.1%] over 2 years).

Conclusions  In middle-aged adults with an FRS of less than 10% and evidence of subclinical atherosclerosis, rosuvastatin resulted in statistically significant reductions in the rate of progression of maximum CIMT over 2 years vs placebo. Rosuvastatin did not induce disease regression. Larger, longer-term trials are needed to determine the clinical implications of these findings.

Trial Registration  clinicaltrials.gov Identifier: NCT00225589

Published online March 25, 2007 (doi:10.1001/jama.297.12.1344).

Author Affiliations: Departments of Medicine (Dr Crouse), Neurology (Dr Riley), and Public Health Sciences (Mr Evans), Wake Forest University, Winston-Salem, NC; AstraZeneca, Wilmington, Del (Dr Raichlen); AstraZeneca, Macclesfield, England (Dr Palmer); Caritas Carney Hospital, Boston, Mass (Dr O’Leary); and Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands (Drs Grobbee and Bots).

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