NEW YORK (Reuters Health) – In patients hospitalized for infection, continuing pre-existing statin therapy does not improve outcomes, and discontinuing the therapy does not lead to an inflammatory rebound. That’s according to a report from Brisbane, Australia published online October 19 in the American Journal of Respiratory and Critical Care Medicine.
Dr. Peter S. Kruger and colleagues at Princess Alexandra Hospital and the University of Queensland point out that prior studies have indicated that statins reduce the inflammatory response to infection and improve outcomes, but guidelines suggest caution with statin use during acute illness requiring hospitalization, because of potentially serious side effects.
Whether to continue statin therapy or not “remains unanswered for patients hospitalised with infection,” the authors explain.
To investigate, they conducted a randomized double-blind controlled trial — the first such — in which 150 patients on pre-existing statin therapy who required hospitalization for infection were assigned to receive 20 mg atorvastatin or placebo in addition to antibiotic treatment.
The primary endpoint was progression of sepsis during hospitalization. Initially, the rate of severe sepsis was 32% in both arms of the study. This declined similarly over time in both groups, so that by day 3 the odds ratio for severe sepsis compared to baseline was 0.43 in the placebo group and 0.50 in the atorvastatin group; corresponding ORs at day 14 were 0.14 and 0.12.
Rates of organ dysfunction followed a similar pattern.
Changes in inflammatory response were also not significantly different in the two groups. For example, by day 10 the IL-6 level had dropped by 49 pg/mL from baseline in the placebo group and by 46 pg/mL in the atorvastatin group.
“In conclusion, our study does not support a beneficial role of continuing pre-existing statin therapy on sepsis and inflammatory parameters,” Dr. Kruger and colleagues conclude.
They add, “This trial only assessed those patients on prior statin therapy and the majority of patients were not critically ill. Further trials are required to delineate the place of denovo and continuation of statin therapy in patients with sepsis and to clarify its impact in patients with severe sepsis.”
Continuation of Statin Therapy in Patients with Presumed Infection: A Randomised Controlled Trial
Am J Respir Crit Care Med 2010.