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Full-Text Articles in Health Law and Policy
Statins And Adverse Cardiovascular Events In Moderate-Risk Females: A Statistical And Legal Analysis With Implications For Fda Preemption Claims, Theodore Eisenberg, Martin T. Wells
Statins And Adverse Cardiovascular Events In Moderate-Risk Females: A Statistical And Legal Analysis With Implications For Fda Preemption Claims, Theodore Eisenberg, Martin T. Wells
Cornell Law Faculty Publications
This article presents: (1) meta-analyses of studies of cardioprotection of women and men by statins, including Lipitor (atorvastatin), and (2) a legal analysis of advertising promoting Lipitor as preventing heart attacks. The meta-analyses of primary prevention clinical trials show statistically significant benefits for men but not for women, and a statistically significant difference between men and women. The analyses do not support (1) statin use to reduce heart attacks in women based on extrapolation from men, or (2) approving or advertising statins as reducing heart attacks without qualification in a population that includes many women. The legal analysis raises the …