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(197) ferraro_ricerca_15 novembre 2008.doc

Rosuvastatin appears to lower the risk of heart disease in healthy people. Even healthy people seem to benefit from taking statins.Science The results of a study examining whether a potent cholesterol-lowering drug decreases the risk of heart disease are out1. Rosuvastatin was given to 17,802 seemingly healthy people, and their chance of developing heart problems plummeted. The results, published in the New England Journal of Medicine, have revealed a number of questions about how to prevent heart attacks. Is exercise and a low-fat diet enough, or should large swathes of the population be prescribed preventative medication? Nature News gets to the heart of the matter. So taking cholesterol-lowering drugs helps prevent heart attacks even when you don't have
high cholesterol?

That's right. The study's results are striking. In a large group of seemingly healthy people, those taking the drug rosuvastatin rather than the placebo were 44% less likely to have a major heart attack or heart-related illness and 21% less likely to die from heart disease. Rosuvastatin is marketed as Crestor by the pharmaceutical company AstraZeneca, and it is a statin — a class of drugs used widely by patients at risk of heart attacks to lower levels of dangerous cholesterol. The people in the JUPITER trial (Justification for the Use of Statins in Prevention: an International Trial Evaluating Rosuvastatin) were all at or near the age above which heart problems are most common — 50 for men and 60 for women. But they all were deemed healthy in terms of their LDL cholesterol (low-density lipoprotein, or 'bad' cholesterol) levels. All the participants were well below the current LDL concentration guidelines of 8 mmol per litre2, a number set by European cardiologists. Above this level, doctors are advised to prescribe statins at the moment. In fact, the participants of the Crestor trial all had LDL concentration levels less than 3.4 mmol per litre. The one thing the participants all had in common was increased levels of high-sensitivity C-reactive protein, which is used as a marker for inflammation, and its levels can be used to predict future heart problems. But none of the trial participants would have gone to their doctors showing any heart-disease-related symptoms, and so they would not have been referred for medication. Does that mean we should all take statins to make sure we never have a heart attack — even if
we don't have high cholesterol?

The trial's results suggest that giving even healthy people statins will help prevent heart attacks. But before rushing out to the doctor for a prescription, there are words of caution to heed. Mike Knapton, associate medical director for the British Heart Foundation, says that even with the results of this study he wouldn't advocate mass drugging of the population. "There is evidence that medicating large numbers of people has negative effects," says Knapton. "There are some important questions to be answered before offering statins to healthy people. What are those questions?
One of the big questions is about what actually caused the striking results seen in the study. Timothy Gardner, president of the American Heart Association, said in a statement that the trial had not been designed to tell whether the health benefits were attributed to less inflammation of the arteries — tracked by levels of the high sensitivity C-reactive protein (hsCRP) — or to lower LDL levels. "Statins lower both LDL cholesterol and hsCRP. Thus, the findings presented today cannot determine whether lowering cholesterol, reducing inflammation or a combination of both is responsible for the effects seen in this paper," he said. To find the answer to that question, the trial would have had to include a large proportion of the general population that was left out in this case, says Knapton — including those under 50 and those with normal levels of C-reactive protein. Extrapolating to the general population can't be done without more data, he adds. What, if anything, does this trial mean for high-risk patients?
Rory Collins, co-director of the UK's Medical Research Council's clinical trials service unit, at the University of Oxford, and head of the data-monitoring group for this trial, says that the study's principal conclusion has been overlooked: taking nominally healthy people and lowering their LDL had a great benefit, and this shows that LDL levels need to be kept much lower than previously thought in patients at high risk of heart disease, he says. "The guidelines will have to be complexly modified," Collins says. "JUPITER has unequivocally proved that all of our cholesterol levels should be 1 mmol per litre." How long do these drugs need to be taken to see the benefits?
This rosuvastatin study was stopped early — after just two years — because the results were already clear. Collins was head of the group that recommended that move. This was the right thing to do, says Knapton, but it leaves unanswered the questions of long-term effects of the drug. The trial doesn't address whether the beneficial effects are maintained over time, or if any bad side effects develop with long-term usage of the drug. I heard something about statins causing cancer — will the risks of this drug outweigh its

Statins have had a bumpy ride lately. The drugs have been shown to cause muscle problems. And Vytorin, marketed by Merck and Schering-Plough, a drug that combines a statin and a compound that stops cholesterol being absorbed, recently made headlines when a trial showed a higher cancer risk in those taking the combo drug. A deeper analysis of the data suggested that this scare was unfounded. The two big statin worries — myopathy (muscle weakness) and cancer — weren't a problem in this trial, but there were more cases of physician-reported diabetes in the rosuvastatin arm of the trial. This is perplexing, says Knapton, but not enough to put him off prescribing the drug. Without further study, physician-reported diabetes is not enough evidence that the drug really causes a higher chance of diabetes, the trial's authors report. And how else can I try to avoid a heart attack?
Keeping down the levels of that bad cholesterol is still recommended. But statins aren't the only way to do that: exercise, low-fat food and stopping smoking all help. • References
1. Ridker, P. M. et al. N. Engl. J. Med. 359, 2195-2207 (2008). De Backer, G. et al. European Heart Journal 17, 1601-1610 (2003). >>


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