Adjunctive simvastatin therapy did not improve day-28 survival in adults with suspected ventilator-associated pneumonia (VAP), according to research results published online ahead of print in JAMA.
Investigators performed the randomized, placebo-controlled, double-blind, parallel-group, multicenter trial in 26 intensive care units in France. The 300 participants randomly received either simvastatin (60 mg) or placebo, at the same time as their antibiotic therapy; treatment continued through the patient’s ICU discharge, death, or day 28, whichever occurred first.
Researchers discovered that day-28 mortality was not lower in the simvastatin group when compared to the placebo group (21.2% to 15.2%). In addition, there were no significant differences regarding day-14, ICU, or hospital mortality rates, duration of mechanical ventilation, or changes in SOFA (Sequential Organ Failure Assessment) score, according to the study.
The study was stopped for futility at the first scheduled interim analysis after enrollment of the 300 patients. The futility stopping rules were an absolute increase in day-28 mortality of at least 2.7% with simvastatin compared with placebo after enrollment of the first 251 patients.