GREY:ATBPF - Post by User
Comment by
sidtheritzon Aug 04, 2021 3:50pm
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Post# 33649608
RE:Not much to say ...
RE:Not much to say ...Agree. Also note the following for phase 2:
- During the treatment period, only 1 out of 318 patients administered otenaproxesul had clinically significant, temporary liver enzyme elevations (“LTEs”) — this is a known “class effect” of NSAIDs
- At the post-treatment assessment, patients in the 250 mg, 200 mg and 150 mg treatment arms had LTE incidences of 12.9%, 7.2% and 9.8%, respectively — acetaminophen use, pre-existing liver conditions and concomitant statin use were associated with a majority of the LTE incidents; adjudication yields rates of 4.5%, 3.2% and 3.3%, respectively, suggesting a liver safety
And now it's 5x the normal limit? Makes me suspect that something else is at play here.