RESUMEN
OBJECTIVE: To investigate whether the use of pravastatin reduces the frequency of ventilator-associated pneumonia and whether it is related to favorable outcomes in critical care patients. DESIGN: Two-center, two-arm, randomized, open-label, controlled trial. SETTING: University Hospital and General Hospital of Larissa, Greece. PATIENTS: Consecutive patients were recruited from the intensive care units of the two hospitals. Patient inclusion criteria included mechanical ventilation and intensive care unit stay of >48 hrs. INTERVENTIONS: The two arms consisted of treatment plus oral pravastatin sodium (40 mg) (n = 71 patients, pravastatin group) and treatment without pravastatin (n = 81 patients, control group). Treatment was started after randomization and ended 30 days later. MEASUREMENTS AND MAIN RESULTS: Ventilator-associated pneumonia frequency and intensive care unit mortality at 30 days and at the end of intensive care unit stay were measured. Adverse events related to statin treatment in the intensive care unit were documented. Sixteen patients (22.5%) in the pravastatin group and 28 (34.5%) in the control group (p = .11) presented pneumonia during the 30-day treatment period in the intensive care unit. There was an indication for increased probability of being free from ventilator-associated pneumonia during the 30-day treatment period in the pravastatin group compared to the control group (p = .06) and significantly increased probability during the whole intensive care unit period of stay (p = .04) in the pravastatin group compared to the control group in the subgroup of patients with Acute Physiology and Chronic Health Evaluation scores of ≥ 15. Six patients (8.45%) in the pravastatin group and 16 (19.85%) in the control group died during the 30-day treatment period (p = .06), whereas 10 (14.1%) patients in the pravastatin group and 24 (29.1%) patients in the control group died during the whole period of intensive care unit stay (p = .03). Pravastatin group patients with Acute Physiology and Chronic Health Evaluation scores of ≥ 15 had significantly increased probability of survival compared to controls during the 30-day treatment period (p = .04). Creatine kinase and hepatic function enzyme levels during the whole study period were not significantly different between the pravastatin group and control group. CONCLUSION: This study provides evidence that pravastatin may favorably affect the outcome of critical care patients.