Word: womening
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...reason may be that the field of gender-based medicine, which takes into account the differences between men and women in the diagnosis and treatment of disease, has been slow to catch on, especially in the pharmaceutical industry. Before the 1990s, women were largely excluded from clinical drug trials - an attempt to protect pregnant women from harm and avoid the potentially confounding effects of women's hormone fluctuations. Since then, as studies have actively recruited women, gender-based research has begun to reveal crucial information about how the development of diseases - such as heart disease, lung cancer and autoimmune disorders...
Even acknowledging the lack of data, however, researchers like Dr. Scott Grundy of the University of Texas Southwestern Medical Center in Dallas have long argued that statins should be prescribed to women at moderately high risk for heart disease. Grundy says the underrepresentation of women in drug trials does not discount statins' benefit; it results only in a failure to show a statistically significant effect. Grundy was one of the authors of the 2001 national guidelines for lowering cholesterol and the 2004 revisions that greatly expanded the use of statins - and were criticized because of his and other authors' ties...
...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...
...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...