Cliona McDowell.

We used simvastatin at a dosage of 80 mg based on our previous data from clinical studies,4,5 where simvastatin improved surrogate outcomes and biologic mechanisms implicated in ARDS. The info from our current study and the SAILS trial display that neither a lipophilic statin nor a hydrophilic statin is effective in the treatment of ARDS. The high dosage of simvastatin found in this trial was selected on the basis of our pilot data5 and also preclinical data3 and observational research.13,14 Although we didn’t measure simvastatin concentrations, chances are an adequate simvastatin focus was achieved, for a number of reasons. A prior study involving critically ill sufferers demonstrated that simvastatin at a daily dosage of 80 mg produced systemic drug concentrations which were in the high therapeutic range.15 Furthermore, sufferers received simvastatin for a mean of 10 days.The certainty of results, which was already low, was further downgraded for this reason. Since the treatment results presented by the manufacturer were therefore not really interpretable, an added advantage of ipilimumab in non-pretreated sufferers with advanced melanoma is not proven. G-BA decides on the extent of added benefit The dossier assessment is section of the overall procedure for early advantage assessments supervised by the G-BA.