OBJECTIVES : Assessment of the cost effectiveness of oral simvastatin plus standard therapy versus standard therapy alone in critically ill septic patients

METHODS : This was a multi center, randomized, open label, controlled clinical trial. A total of 145 critically ill patients were randomized, 80 received standard therapy according to Surviving Sepsis Campaign Guidelines 2013 and 65 received simvastatin plus standard therapy. The economic analysis was planned as cost-effectiveness analysis. Only direct medical and non-medical costs were incurred. The primary outcome assessed was the number of survived patients. Per protocol analysis was maintained throughout the analysis.

RESULTS : The clinical findings reported that simvastatin significantly decreased the intensive care unit length of stay (ICU LOS). At 3 months, 52 patients died in the standard group and 35 in the simvastatin group. No death was recorded at 6 and 12 months. Mortality was lower in the simvastatin group compared to the standard group at 12 months, although this was not significant (p=0.15). Total direct medical and non-medical costs were lower in simvastatin group compared to standard group, indicating that the statin therapy is the dominant treatment option. The cost-saving results of simvastatin were largely driven by saving in cost of the ICU LOS and medications in the ICU. The incremental cost-effectiveness ratio (ICER) was negative and therefore was not calculated.

CONCLUSIONS : This study provides a novel preliminary evidence that simvastatin plus standard therapy is likely to be less costly, and more effective in term of survival compared to standard care alone in ICU patients.