Background/Purpose: Fatigue is common in Rheumatoid Arthritis (RA) and has a major impact on quality of life. Individuals with RA are also at increased risk of cardiovascular disease and are often prescribed statin medications. Recent data suggest that statins may be associated with increased fatigue symptoms (Golomb, Arch Intern Med, 2012; 172:1180), but the effect of statins on fatigue in RA has not been studied. This study tests whether statin initiation is associated with increased fatigue in RA. 

Methods: Data were from the longitudinal National Data Bank for Rheumatic Diseases (NDB), for which participants complete questionnaires every 6 months. RA was physician confirmed. Medication use was self-reported. The primary exposure was first-ever initiation of a statin. Participants were classified as exposed if they 1) began taking a statin, 2) took this statin for at least 1 month, and 3) had never taken any statin in the past. Fatigue severity was measured by Visual Analogue Scale (range 0-10): “How much of a problem has fatigue or tiredness been for you in the past week?” The primary outcome was 6-month change in fatigue severity. We used a new-user nested cohort design. Subjects were analyzed as controls until the 6-month interval in which they initiated statin use, during which they were analyzed as exposed. To exclude prevalent statin users, participants were censored beginning in the 6-month interval after exposure. Generalized estimating equations, with a fixed effect term for 6-month interval and robust standard errors, were used to model the effect of statin initiation on change in fatigue, controlling for age, sex, baseline fatigue severity, depressive symptoms, sleep quality, HAQ score, comorbidities, BMI, and RA Disease Activity Index (RADAI) score. Secondary analysis examined the effect of initiation of “high-potency” statins (atorvastatin, rosuvastatin, and simvastatin) on change in fatigue.

Results: Of the 12,482 participants, 80% were female and the mean ±SD baseline characteristics were: age 63 ±12 years, RADAI score 2.4 ±1.4, fatigue 4.1 ±2.5. 3,617 participants (29%) initiated a statin, of which 91% were “high-potency.” Mean 6-month change in fatigue was -0.001 (±0.6) among controls and 0.02 (±2.4) among statin new-users. In adjusted models, new use of a statin was not associated with a significant change in fatigue [(coefficient=0.01; (CI:-0.07,0.10); p=0.8]. Results were similar when analysis was limited to new use of high-potency statins [(coefficient=-0.01; (CI:-0.10, 0.08); p=0.8]. 

Conclusion: In this large longitudinal cohort of patients with RA, there was strong evidence that new use of a statin is not associated with significant risk of increased fatigue. Because the 95% confidence interval (-0.07, 0.10) includes the null and excludes all clinically meaningful values for change in fatigue, we conclude that new use of a statin does not have a clinically important effect on fatigue (Hoenig, American Statistician, 2001; 55:19). Given the importance of statin medications in reducing cardiovascular risk for individuals with RA, these findings have great clinical relevance.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/initiating-statin-medication-and-risk-of-fatigue-in-rheumatoid-arthritis/