The FDA ( Food and Drug Administration ) has approved Crestor ( Rosuvastatin ) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.

The submission package to the FDA was based largely on the results of a pivotal study called METEOR ( Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin ) which measured the effects of Rosuvastatin on plaque build-up in the arteries using carotid intima-media thickness ( CIMT ) and demonstrated a slowing of progression of atherosclerosis in people with early signs of the disease, elevated LDL cholesterol, and low cardiovascular risk, taking Rosuvastatin 40 mg.

Among participants in the Rosuvastatin group, the mean baseline LDL cholesterol level of 155 mg/dL declined to 78 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 mm/y for the Rosuvastatin group vs 0.0131 mm/y for the placebo group ( P<.001 ).
The change in maximum CIMT for the Rosuvastatin group was -0.0038 mm/y for the common carotid artery sites ( P<.001 ), -0.0040 mm/y for the carotid bulb sites ( P<.001 ), and 0.0039 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 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 ).

The METEOR study is part of GALAXY Programme, a large, comprehensive, long-term and evolving global research initiative designed to address important unanswered questions in statin research and to investigate the impact of Rosuvastatin on cardiovascular risk reduction and patient outcomes. To date, the GALAXY Programme has recruited more than 69,000 subjects in more than 55 countries around the world.

Source: 1) AstraZeneca, 2007; 2) JAMA, 2007

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