Randomized Controlled Trial of Atorvastatin in Acute Influenza in the Emergency Department.

Abstract

Objectives: We sought to determine whether atorvastatin administration attenuates the inflammatory response and improves clinical outcomes in acute influenza.

Methods: We conducted a randomized double-blind trial administering atorvastatin 40 milligrams or placebo to adults with confirmed influenza for five days between December 2013-May 2018. Patients were primarily enrolled in the emergency department (ED) at an urban, tertiary-care center. Serum was obtained at enrollment and 72 hours for the primary outcome, change in interleukin (IL-6). Patients reported severity of influenza symptoms over 10 days. We used linear mixed-effects models for the primary comparisons.

Results: Of the 116 enrolled patients, 59 received atorvastatin and 57 received placebo. Groups were well-matched including baseline influenza symptom scores and receipt of an antiviral medication. There was no difference between groups in the change in interleukin-6 (IL-6) levels (P=0.468). However, there were significant differences in the overall influenza symptom scores, favoring faster resolution in the atorvastatin group (P=0.05). For patients presenting within 48 hours of symptom onset, resolution was faster for the overall score (P <0.001) and for the fever (P=0.001), sore throat (P=0.005) and headache (P=0.006) components. No safety concerns were identified.

Conclusion: Atorvastatin administration in acute influenza appears safe. We did not find attenuation of IL-6 with atorvastatin. Patients receiving atorvastatin reported improvement in their clinical symptoms at a faster rate than those in the placebo group, particularly in patients presenting within 48 hours of symptom onset. This trial is registered at ClinicalTrials.gov, Identifier: NCT02056340.