Background: Influenza is associated with high morbidity and mortality and there are limited treatment options for influenza. Statin medications have pleiotropic anti-inflammatory effects. Observational studies have shown patients taking a statin at the time they contract influenza have better outcomes than those who are not. The primary goal of this trial was to determine if administration of atorvastatin would attenuate the inflammatory response and, secondarily, improve clinical outcomes.
Methods: We conducted a randomized controlled trial administering atorvastatin 40mg or placebo orally for 5 days to adults (age >18 years) with confirmed influenza. Patients were excluded if they were taking a statin, allergic or taking a contraindicated medication, pregnant, breastfeeding, had liver dysfunction or rhabdomyolysis at screening or part of a protected population. Patients were primarily enrolled in the emergency department (ED) at a single urban tertiary care center. Serum samples were obtained at time of enrollment and at 72 hours post enrollment for the primary outcome, change in IL-6. Patients also reported the severity of their influenza symptoms over 10 days. Linear mixed-effects models were used for the primary comparisons.
Results: We excluded 4214 patients and 528 declined participation. The most common exclusion was concomitant statin use.We enrolled 116 patients, 59 in the atorvastatin group and 57 in the placebo group. Groups were well-matched with regard to age, sex, race, comorbid conditions and baseline influenza symptom score (all p >0.05). There was no difference in rates of discharge from the ED, ward or ICU admission between groups (p=0.083). There was no difference observed between groups in the change in IL-6 levels (p= 0.30). However, there was a significant effect observed in IL-10 levels (p=0.044). There were significant differences in the overall influenza symptom score between groups (p=0.049) favoring faster resolution in the atorvastatin group. There were no significant differences in safety concerns identified between the groups
Conclusion: Atorvastatin administration in patients with acute influenza appears safe. We found attenuation of IL-10 levels in the atorvastatin group, but not in IL-6 levels. Patients receiving atorvastatin reported improvement in their clinical symptoms at a faster rate than those in the placebo group.