Word: trial
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...Jupiter TrialGrundy says he now has the evidence he's been waiting for. In a paper published in February in the journal Circulation, researchers analyzed data on women who took part in the Jupiter trial, a large, industry-funded study that sought to compare the effectiveness of the statin Crestor (rosuvastatin) with that of a placebo in healthy patients. The study, which ended in 2008, involved nearly 18,000 participants - including 6,801 women, more than in any previous statin trial - who had high levels of C-reactive protein, a risk factor for heart disease, but did not have high...
Meanwhile, women on Crestor were more likely to develop diabetes compared with those getting a placebo - a result not seen in men. And because the trial lasted only 1.9 years on average, researchers say the full magnitude of the side effects may not have been captured...
Judith Hsia, senior director for clinical development at AstraZeneca, which makes Crestor, says the trial was designed to measure the statin's effect on all end points together, not individual end points. "The people who had bypass surgery or stenting would not characterize that as a nonevent," says Hsia. "It's not death, but it's still substantial...
...seems unperturbed by criticism of the Jupiter trial. In February, on the basis of Jupiter data, the agency expanded the eligible patient population for Crestor to include older healthy at-risk adults. The move could increase the number of women taking statins by many millions, according to calculations by Dr. Jon Keevil of the University of Wisconsin. Researchers will continue to disagree over whether that is heartening news...
...It’s a trial by fire [for these newcomers], and we’ll be better for it long term,” Miller said. “I just think this year we live with peaks and valleys and some young decision-making...