GREY:ATBPF - Post by User
Comment by
WalkOverTheStrton Aug 05, 2021 6:51am
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Post# 33653409
RE:RE:Long history of Safety Concerns
RE:RE:Long history of Safety Concerns snozz
Where are your facts, b/c they paused a trial and then restarted after review? Seems pretty weak when PH2 had same liver profile to acetaminophen use ... (side 38)
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 profile comparable to commonly prescribed NSAIDs
https://secureservercdn.net/72.167.241.46/ln9.cea.myftpupload.com/wp-content/uploads/2021/07/Antibe-Corporate-Presentation-July-2021.pdf