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by refurb
2039 days ago
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I haven't dug into the older approvals of Lipitor into a ton of detail, but you can find them on the FDA website. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ev... It looks like the initial approval of Lipitor was in the hundreds of patients. Now, statins were brand new and not used really broadly. Pfizer did a ton of follow up studies, but looking at the most current label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/02... The two biggest trials, ASCOT and CARDS, which measured improvements in mortality (needed to be big trials to measure any difference), they were ~10,000 and ~2,000 patients each. So suffice to say, Lipitor, which is used in a massive population, has probably been tested, in clinical trials, on a total number of patients comparable to the Pfizer Covid vaccine trial. Obviously the duration of the Lipitor trials were much longer and there a massive body of clinical data from actual use, but it at least gives you some perspective on numbers. |
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