Resumen de The clinical outcome of simvastatin plus standard therapy versus standard therapy alone in critically ill septic patients: Randomized controlled clinical trial
Manal Hamed El Hamamsy, Sara Mostafa Amin, Naglaa Bazan, Mohamed Abd Al Salam El Gendy, Mamdouh Ahmed Zaki
Background: Statin therapy during Intensive Care Unit (ICU) stay has been associated with a reduction in all-cause hospital mortality in some studies. This association was especially noted in septic patients. However, potential benefit needs to be validated in randomized, controlled trials.
Objective: The purpose of this study was to compare the effect of simvastatin plus standard therapy on mortality and total ICU Length Of Stay (LOS) to that of standard therapy alone in critically ill septic patients.
Method: A prospective randomized, open-label, controlled pilot clinical trial was conducted on patients diagnosed with sepsis/severe sepsis as defined by the American College of Chest Physicians (ACCP). Hundred patients met the study criteria and were randomized into two groups; a standard group who received standard treatment and simvastatin group who received the standard treatment plus 40 mg simvastatin. Primary outcomes were 28 days ICU mortality and total ICU LOS. Plasma C-Reactive Protein (CRP), total Creatine Kinase (CK) and liver enzymes [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] were measured as secondary outcome measures.
Results: A total of 72 patients completed the study. Simvastatin was well tolerated, with no increase in adverse events between the two groups. Total ICU LOS was significantly lower in the simvastatin group. However, the number of patients with 28 days ICU mortality in the simvastatin group was lower compared to standard group; but survival failed to reach statistical significance. Similarly, plasma C-reactive protein failed to reach statistical significance between the two groups.
Conclusions: Treatment with simvastatin 40 mg in patients with sepsis/severe sepsis is safe and associated with an improvement in number of deaths and ICU LOS but without subsequent improvement in survival
