Abstract 19685: Statins and Tinnitus: An Innovative Analysis

Background: Some patients cite tinnitus as a statin adverse effect (AE), often attending acknowledged statin AEs, but trends to tinnitus benefit have also been reported. Oxidative stress promotes tinnitus. Since statins have both antioxidant and prooxidant effects, tinnitus effects might depend on which predominate. Prooxidant predominance has been linked to statin muscle/fatigue AEs. We therefore conjectured that change in tinnitus (αTinnitus) on statins but not placebo would significantly relate to change in a fatigue outcome (αFatigue) that statins affect. Method: In a 6 month double-blind placebo-controlled RCT, 1016 adults (median age 57) without diabetes or CVD (LDL 115-190mg/dL) were randomized equally to simvastatin (simva) 20mg, pravastatin (prava) 40mg, or placebo. We elicited change-in (α)Tinnitus from baseline, and summed self-rated α exertional fatigue with the inverse of α energy to produce “αFatigue.” Ordinal logit with robust SEs examined a) statin effect on αTinnitus, stratified at median age; and b) prediction of αTinnitus by αFatigue.Analyses stratified by randomization arm and adjusted for age and baseline tinnitus. Results: In the younger stratum (age < median), prava (vs placebo) increased tinnitus (β(SE)=.94(.43)p=.028) with borderline increase on combined statins (β(SE)=.58(.31)p=.064). No effect was observed with simva or in the older stratum. However, for each statin group but not placebo, αTinnitus was significantly predicted by αFatigue (see Table 1). Discussion: αTinnitus on statins was significantly predicted by αFatigue on statins, which (other evidence suggests) may serve as a marker of prooxidant predominance. Findings were consistent across statin groups (p<.05 for all), with no suggestion of a similar finding on placebo (p=0.9). These findings comport with a view by which bidirectional effects of statins on oxidative stress/energetics may contribute to variable and perhaps bidirectional effects on tinnitus.