Friday, November 14, 2008

JUPITER trial - will you change your practice?

The findings of a large statins trial presented at the Am Heart Association meeting on 9 November 2008 dominated the news and stirred up debates.

The study, called JUPITER trial, funded by AstraZeneca (maker of rosuvastatin, marketed as Crestor, the drug in the trial) is a large international, double-blinded, placebo controlled randomised clinical trial including 17,802 "healthy" men and women with normal LDL cholesterol but elevated CRP (C-reactive protein) assigned to receive either 20mg of daily dose of rosuvastatin or placebo.

The researchers found the rosuvastatin reduced their risk of heart attack ( 54% ), stroke (48% ), in need of angioplasty or bypass surgery (46% ) and death from any cause ( 20% ). The trial leader, Dr Paul Ridker, who receives grant from the drug company, said expanding the use of statin could prevent 250,000 heart attacks, strokes, vascular procedures or death over 5 years. The JUPITER trial was designed a 4-year study but stopped after 1.9 years because of the benefits found.

Opinions on the findings are mixed and many questions raised. Some said that clinical practice on CRP testing and statin therapy would be affected by this important landmark study while some questioned the short follow-up and long-term safety of low LDL levels achieved in this trial. Dr Mark Hlatky wrote in the NEJM's editorial "the evidence should be examined critically" before drug treatment is expanded and "Long-term safety is clearly important in considering committing low-risk subjects without clinical disease to 20 years or more of drug treatment."

NEJM published this article and the accompanying editorial ( free f/t ) on its website on 9 November 2008 and invited doctors to contirbute their thoughts on the JUPITER results.


Source: "Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein" Published at www.nejm.org November 9, 2008 (10.1056/NEJMoa0807646)

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