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PJ Online homeThe Pharmaceutical Journal
Vol 278 No 7447 p419
14 April 2007

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Rosuvastatin does not lead to regression of atherosclerosis

Patients receiving rosuvastatin (Crestor) experience reduced progression of carotid atherosclerosis compared with those taking placebo, but not a regression of disease, a recent study shows (JAMA 2007;297:1344).

The study, funded by AstraZeneca (maker of rosuvastatin), looked at whether the statin could slow the progression, or cause regression, of atherosclerosis, as measured by carotid intima-media thickness (CIMT) — an independent predictor of cardiovascular events.

Researchers in the US and Europe randomised 984 middle-age, low-risk patients to receive 40mg of rosuvastatin daily or placebo for two years. They found that the change in maximum CIMT (for 12 carotid artery sites; primary outcome measure) was less in the rosuvastatin group than the placebo group (difference –0.0145mm/year, 95 per cent confidence interval –0.0196 to –0.0093; P<0.001). Regression of CIMT was not significant within the rosuvastatin group.

The study does not address whether treatment with rosuvastatin improves clinical outcomes or mortality. In an accompanying editorial (ibid, p1376) Michael Lauer from the Cleveland Clinic Lerner College of Medicine, Ohio, discusses the appropriateness of measuring surrogate endpoints, such as CIMT, for primary prevention trials. He says: “The evidence is not yet sufficient to comfortably conclude that a reduction in progression of atherosclerosis by carotid imaging in low-risk individuals will necessarily translate into a reduction in clinical events.” Low-risk individuals should not routinely undergo arterial imaging followed by statin therapy on discovery of asymptomatic disease, he suggests.

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