The effects of statin therapy on inflammatory cytokines in patients with bacterial infections: a randomized double-blind placebo controlled clinical trial

TY - JOUR

T1 - The effects of statin therapy on inflammatory cytokines in patients with bacterial infections

T2 - a randomized double-blind placebo controlled clinical trial

AU - Novack, Victor

AU - Eisinger, Miruna

AU - Frenkel, Amit

AU - Terblanche, Marius

AU - Adhikari, Neill K. J.

AU - Douvdevani, Amos

AU - Amichay, Doron

AU - Almog, Yaniv

AU - Terblanche, Marius

PY - 2009/7

Y1 - 2009/7

N2 - Objective: To determine if statin therapy reduces the incidence of severe sepsis and the levels of inflammatory cytokines in patients with acute bacterial infection.Design: Double-blind placebo controlled randomized clinical trial.Setting: Department of medicine and medical intensive care unit in a tertiary university medical center.Patients and participants: A total of 83 patients with suspected or documented bacterial infection were enrolled. We randomly assigned 42 patients to receive 40 mg of simvastatin orally, followed by 20 mg of simvastatin, and 41 to receive matching placebo.Measurements and results: The study was prematurely terminated due to slow recruitment rate. Here we report the analysis of the secondary outcome: change in cytokines levels at 72 h. Both groups were evenly matched in terms of co-morbidity and severity of illness on admission. Four of the 83 patients enrolled developed severe sepsis, two in each group. No difference was observed in other clinical variables and there were no mortalities. Cytokine levels were randomly assessed in 40 patients (20 in each group). Both TNF-alpha and IL-6 levels were significantly reduced in the simvastatin group (p = 0.02 and p = 0.02, respectively), while no such difference was observed in the placebo group (p = 0.35 and 0.39, respectively).Conclusions: Statin therapy may be associated with a reduction in the levels of inflammatory cytokines in patients with acute bacterial infections. Large controlled trials will determine if this reduction will translate into a clinical benefit.

AB - Objective: To determine if statin therapy reduces the incidence of severe sepsis and the levels of inflammatory cytokines in patients with acute bacterial infection.Design: Double-blind placebo controlled randomized clinical trial.Setting: Department of medicine and medical intensive care unit in a tertiary university medical center.Patients and participants: A total of 83 patients with suspected or documented bacterial infection were enrolled. We randomly assigned 42 patients to receive 40 mg of simvastatin orally, followed by 20 mg of simvastatin, and 41 to receive matching placebo.Measurements and results: The study was prematurely terminated due to slow recruitment rate. Here we report the analysis of the secondary outcome: change in cytokines levels at 72 h. Both groups were evenly matched in terms of co-morbidity and severity of illness on admission. Four of the 83 patients enrolled developed severe sepsis, two in each group. No difference was observed in other clinical variables and there were no mortalities. Cytokine levels were randomly assessed in 40 patients (20 in each group). Both TNF-alpha and IL-6 levels were significantly reduced in the simvastatin group (p = 0.02 and p = 0.02, respectively), while no such difference was observed in the placebo group (p = 0.35 and 0.39, respectively).Conclusions: Statin therapy may be associated with a reduction in the levels of inflammatory cytokines in patients with acute bacterial infections. Large controlled trials will determine if this reduction will translate into a clinical benefit.

KW - Statins

KW - Infection

KW - Sepsis

KW - Inflammation

KW - Cytokines

KW - SEVERE SEPSIS

KW - EFFICACY

KW - SAFETY

U2 - 10.1007/s00134-009-1429-0

DO - 10.1007/s00134-009-1429-0

M3 - Article

SN - 0342-4642

VL - 35

SP - 1255

EP - 1260

JO - Intensive Care Medicine

JF - Intensive Care Medicine

IS - 7

ER -