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Trial stopped early due to success

Trial stopped early due to success

A huge trial looking into a cholesterol-lowering drug has been halted early after dramatic reductions in illness and death were seen in treated patients.

Scientists were investigating the effects of rosuvastatin on almost 18,000 patients with low-to-normal cholesterol levels but raised concentrations of an inflammation protein.

Under normal circumstances, the patients would not be considered at risk of suffering a heart attack, stroke, or dying from a heart-related cause.

Yet those receiving medium doses of the drug, sold under the brand name Crestor, experienced far fewer adverse heart events than those given a non-active placebo.

Heart-attack risk was reduced by 54% and stroke by 48%. The combined risk of heart attack, stroke and heart-related death fell by by 47%, as did the odds of undergoing surgical procedures.

Because the benefits of taking the drug were so clear, an independent monitoring board halted the trial more than six months early.

All of the patients were apparently healthy, but all had high levels of C-reactive protein (CRP), an inflammation marker believed to be linked to heart disease.

Writing in the New England Journal of Medicine, the researchers from Harvard Medical School in Boston, US, reported: "The reduction in the hazard seen in our trial, in which enrolment was based on elevated high-sensitivity C-reactive protein levels rather than on elevated LDL cholesterol levels, was almost twice this magnitude and revealed a greater relative benefit than that found in most previous statin trials."

Copyright © Press Association 2008

New England Journal of Medicine

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