[5] [6] However, the absolute risk remained low , and the study's observational design could not definitively establish causation
The approval, for patients with MASH with moderate to advanced liver scarring, was based on results of the Phase III MAESTRO-NASH trial, where the MASH resolved in 25.9% of patients who received an 80-mg dose of Rezdiffra and 29.9% of those taking 100 mg, with no worsening of fibrosis
Possible Side Effects / Considerations Mild gastrointestinal symptoms such as nausea, bloating, or diarrhea (often most noticeable during early weeks)
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According to the MHRA SmPC, no dose adjustment is required for patients with renal or hepatic impairment , though closer clinical monitoring is advised in severe renal impairment due to potential dehydration risk from gastrointestinal side effects
