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Tuesday, November 19, 2002The study hopes to follow 15,000 patients for three to four years. Ridker said the study will comprise men over 55 and women over 65 who have no evidence of heart disease. All study participants must have an LDL, or "bad cholesterol" level, of less than 130 and a CRP level of less than two. Patients in the multi-site, randomized study will not know whether they are taking a placebo or the drug rosuvastatin. Rosuvastatin is made by AstraZeneca and received approval this month for use in the Netherlands. It has not been approved for use in the United States. The U.S. Food and Drug Administration is overseeing the clinical trial, which is being sponsored by the drugmaker. Meanwhile, the normally statin-boosterish American Heart Association has some uncharacteristically cautious words on the subject: "When we have new information we need to evaluate it very carefully before making recommendations to physicians and to the public about how to deal with this new information because you don't want to make a strong recommendation now, only to get new information in the future that may suggest that the initial recommendation was not correct," Dr. Robert Bonow, president of the American Heart Association, cautioned. He said more research is needed even while all research on CRP is being reviewed. Exactly. Hopefully, Dr. Ridker will be more forthcoming with his data than he was in the study he published last week. posted by Sydney on 11/19/2002 06:50:00 AM 0 comments 0 Comments: |
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