Word: crestor
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Dates: during 2010-2019
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...gender-specific analysis showed that women who took 20 mg of Crestor daily for an average of 1.9 years had a 46% reduction in cardiovascular events - similar to the 42% reduction in men - compared with the placebo group. "I said once we had the large numbers of women, we'd see benefit. Jupiter now provides that evidence," says Grundy...
Other researchers say that evidence is muddy. The reduction in cardiovascular events sounds impressive until you take a closer look. Men taking Crestor had a lower risk of hard events, including fatal and nonfatal heart attack and stroke. But the only statistically significant benefits for women treated with Crestor involved less extreme end points, like hospitalization for unstable chest pain and arterial revascularization (a category of procedures that includes major surgery). To prevent one event, 36 women would need to take the statin for five years - a modest result, critics...
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...