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Randomized Controlled Trial
. 2025 Apr 29;26(3):600-608.
doi: 10.5811/westjem.33580.

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

Maureen Chase  1 , Michael N Cocchi  1   2 , Anne V Grossestreuer  1 , Xiaowen Liu  1 , Jacob Vine  1 , Ari L Moskowitz  1   3 , Michael W Donnino  1   4
Affiliations
Randomized Controlled Trial

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

Maureen Chase et al. West J Emerg Med. .

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.

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Conflict of interest statement

Conflicts of Interest: By the WestJEM article submission agreement, all authors are required to disclose all affiliations, funding sources and financial or management relationships that could be perceived as potential sources of bias. No author has professional or financial relationships with any companies that are relevant to this study. There are no conflicts of interest or sources of funding to declare.

Figures

Figure 1
Figure 1
Screening and enrollment for clinical trial on the effect of atorvastatin vs placebo in patients with acute influenza infection.
Figure 2
Figure 2
Biomarker mixed model analysis in a study of the effect of atorvastatin vs. placebo in acute influenza. Atorvastatin group in blue, placebo group in red. IL, interleukin; TNF, tumor necrosis factor; VCAM, vascular adhesion molecule; VEGF, vascular endothelial growth factor.
Figure 3
Figure 3
Influenza symptom severity mixed model analysis in this study examining the effect of atorvastatin in acute influenza. Atorvastatin group in blue, placebo group in red. P-values reflect the model over 10 days, asterisks denote days with significant differences between groups on individual days.
Figure 4
Figure 4
Influenza symptom severity score by treatment, patients with symptom duration ≤48 hours. In a study of the effect of atorvastatin vs placebo in acute influenza, this figure represents the self-reported influenza symptom severity scores in patients presenting within 48 hours of symptom onset.
See this image and copyright information in PMC

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