Abstract
BACKGROUND: Dyslipidemia is an important condition in patients with rheumatoid arthritis (RA). This study compared the effectiveness and safety of a low-dose rosuvastatin/ezetimibe formulation for dyslipidemia in RA and osteoarthritis (OA). METHODS: This multicenter, open-label, clinical trial enrolled patients >19 years of age with RA and or hand/knee OA who met the prescribing indications for rosuvastatin/ezetimibe in primary hypercholesterolemia or mixed dyslipidemia, and the Korean insurance criteria. All the patients received rosuvastatin 5 mg/ezetimibe 10 mg daily. The primary endpoint was a low-density lipoprotein cholesterol (LDL-C) reduction ≥ 50% from baseline at 12 weeks. RESULTS: The study recruited 162 patients with RA and 119 with OA, of whom 143 RA and 107 OA patients completed the follow-up and were included in the final analysis. Compared to the OA group, the RA group was older, had more females, had a lower body mass index, and a higher C-reactive protein level. The primary endpoint of an LDL-C reduction ≥ 50% from baseline was achieved in 79.7% of the RA group and 70.1% of the OA group (P = .1086). No significant differences were found in the safety endpoints. In the univariate linear regression analysis, baseline LDL-C levels were associated with absolute LDL-C reduction. This association remained significant in the multivariate analysis. The Disease Activity Score-28 for RA with erythrocyte sedimentation rate, C-reactive protein level, age, body mass index, current smoking, hypertension, diabetes, and daily glucocorticoid dose, were not significantly associated. CONCLUSION: The efficacy and safety of low-dose rosuvastatin/ezetimibe in reducing LDL-C levels were similar between the RA and OA groups. Baseline LDL-C level was the sole independent factor associated with LDL-C reduction, irrespective of inflammatory status.