GREY:ATBPF - Post by User
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WalkOverTheStrton Aug 06, 2021 7:20pm
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PH2 Liver transient elevatisame as you guessed it nasaids...
PH2 Liver transient elevatisame as you guessed it nasaids... https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bph.14641
3.7 Liver-related effects
Blood levels of liver enzymes (including alanine transaminase and aspartate transaminase) were measured on Days 7 and 14 of treatment and at 2 weeks post-treatment (Day 28). Over the 14-day treatment period, clinically insignificant, treatment-related transient elevations in liver transaminases were observed in 7% of subjects receiving ATB-346 and 7% of subjects receiving naproxen.
One subject receiving ATB-346 had clinically significant, treatment-related, transient transaminase elevations during this period. At the 2-week post-treatment assessment, 5.4% of the ATB-346-treated subjects had clinically significant, treatment-related, transient transaminase elevations that had resolved or were resolving. Cumulative data from the three clinical trials in which ATB-346 has been administered at 250 mg once daily for 10–14 days reveal a 4.7% overall incidence of clinically significant increases in liver transaminases. This is comparable to what has been observed with the use of NSAIDs such as diclofenac, naproxen, and piroxicam (~4%) and well below that observed with acetaminophen (39%; National Institute of Health, n.d.). One naproxen-treated subject had clinically significant elevations of alkaline phosphatase and total bilirubin at the end of treatment (Day 14).