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Spontaneous reports of acute liver injuries (ALI) in patients taking dronedarone triggered an EMA alert in 2011. This study aimed to assess the risk of ALI for class III antiarrhythmic drugs controlling for the use of other potential ALI-inducing drugs.Between 2010 and 2014, consecutive ALI cases (≥50 years-old) were identified across Germany. ALI was defined as a new increase in at least one of the...
In uncontrolled clinical studies, ursodeoxycholic acid (UDCA) had a beneficial effect on nonalcoholic steatohepatitis (NASH). However, a large controlled trial using UDCA (13‐15 mg/kg/day) was unable to confirm these results. Accordingly, a randomized, placebo‐controlled study was initiated with a high dose of UDCA (23‐28 mg/kg/day). The allocation of patients and the evaluation of liver histology...
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