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Context/objective: The aim of this study was to examine the effect of statins and other lipid-lowering agents on the development of Graves orbitopathy (GO) in patients with newly diagnosed Graves disease (GD).Methods: Our sample included the full adult population of individuals living in Sweden with newly diagnosed GD between 2005 and 2018 (n = 34 894). We compared the GO incidence in statin users (n = 5574) and nonusers (n = 34 409) by applying Cox regression with a time-varying exposure variable. We adjusted for age, sex, and treatment for hyperthyroidism in the multivariate analyses.Results: Periods of nonusage lasted for a median of 4.3 years (interquartile range [IQR] 1.2-8.4), whereas periods of usage lasted for a median of 4.7 years (IQR 2.0-8.1). Among statin users, 77.1% had used simvastatin, 28.9% atorvastatin, and 8.2% had used other statins. Statin users were found to be significantly less likely to develop GO. In the main analysis based on the full cohort, the unadjusted hazard ratio (HR) was 0.74 (CI 0.65-0.84, P < .001), whereas full adjustment altered the effect to 0.87 (CI 0.76-1.00, P = .04). The main results were largely driven by men; the fully adjusted HR was 0.78 (CI 0.58-1.04, P = .09) for men and 0.91 (CI 0.79-1.06, P = .24) for women. Lipid-lowering agents other than statins did not exhibit a similar protective effect.Conclusion: In newly diagnosed patients with GD, treatment with statins may protect against the development of GO. Statins should be investigated in a clinical trial as a preventive treatment for GO in newly diagnosed patients with GD. [ABSTRACT FROM AUTHOR]