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Medical Files
Jupiter trial hits home with a bang

By Rafael Castillo, MD
Philippine Daily Inquirer
First Posted 23:44:00 11/14/2008

Filed Under: Health, Lifestyle & Leisure

NEW ORLEANS, Louisiana—This city of blues and jazz sizzled with activity as more than 20,000 heart experts and scientists from all over the world gathered to discuss what’s hot in the treatment of cardiovascular diseases during the 2008 scientific sessions of the American Heart Association.

Certainly one of the hottest findings during the current year is the result of a landmark trial showing that a drug from the class of cholesterol-lowering drugs called statins has been shown to cut the risk of heart attack, stroke and cardiovascular death in apparently healthy individuals.

Big boost

The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin—with the acronym Jupiter—has given the field of primary prevention a big boost since apparently healthy individuals with average or normal cholesterol levels have not previously been considered a serious candidate for treatment with a cholesterol-lowering drug.

The fact though is that half of patients developing stroke and heart attack, and dying prematurely, come from this segment of the population. They form the base of the pyramid of patients at risk for these complications. The risk however in this population was previously deemed low and doctors have been lulled into a false sense of complacency and security with “normal” LDL cholesterol levels, without even checking the C-reactive-protein level, which is a more accurate indicator of cardiovascular risk.

In Jupiter, individuals with normal low-density lipoprotein or “bad” cholesterol but high CRP levels, benefited from a maintenance dose of the statin rosuvastatin which significantly reduced the primary composite end point of nonfatal heart attack, nonfatal stroke, hospitalization for unstable chest pains, need for revascularization (either angioplasty or by-pass surgery) and confirmed death from cardiovascular causes. The reduction was not only a modest one, but a significant 44-percent risk-reduction compared with individuals treated with placebo or dummy pill.

Dr. Paul Ridker of the Brigham and Women’s Hospital, in Boston, reported the benefits extended to all subgroups, including patient populations, for which data on primary prevention of cardiovascular diseases are limited. What is noteworthy too is that this big reduction in clinical complications was noted in less than two years among patients considered healthy by conventional definitions. This is likely to change the treatment guidelines which doctors usually follow.

Patients included in the trial had median LDL-cholesterol level of 108 mg/dL—the type of patients a doctor usually sends home without prescription. This is the first trial that such patients, presenting also with an elevated CRP, can benefit from statin treatment, in terms of reducing cardiovascular complications by half.

Not everyone though with normal LDL-cholesterol levels should receive statin therapy. Only those with elevated high-sensitivity CRP levels should be considered appropriate candidates for treatment. The CRP level detects the amount of low-grade inflammation or swelling happening in the body; and atheroslcerotic narrowing of the artery is actually a form of low-grade inflammation.

Shift in paradigms

Initially designed as a four-year study, Jupiter was stopped by its sponsor (AstraZeneca) after just 1.9 years based on recommendations from an independent data monitoring board at that point of a reduction in cardiovascular complications and death among patients treated with rosuvastatin compared with those treated with placebo.

There will definitely be some shift in paradigms with the use of cholesterol-lowering drugs such as statins. Statin usage has been swinging to and fro like a pendulum—from a grave hesitation and reluctance to over-enthusiasm and overuse. It’s about time we stop the swinging of the pendulum and make it settle on the middle. Hopefully, our heart experts will be able to translate results of this trial into practical terms for every ordinary medical practitioner to be guided as to who exactly should be prescribed statins.



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