Bak Seong-Hyeok, Lee Kyung-Ann, Kim Sung Soo, Kim Sang-Hyon, Hong Seung-Jae, Kim Hyun-Sook
Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.
Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.
Medicine (Baltimore). 2025 Jul 4;104(27):e43133. doi: 10.1097/MD.0000000000043133.
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).
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.
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.
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.
血脂异常是类风湿关节炎（RA）患者的一种重要病症。本研究比较了低剂量瑞舒伐他汀/依折麦布制剂治疗RA和骨关节炎（OA）患者血脂异常的有效性和安全性。
这项多中心、开放标签的临床试验纳入了年龄大于19岁、符合原发性高胆固醇血症或混合性血脂异常中瑞舒伐他汀/依折麦布处方指征以及韩国保险标准的RA和/或手/膝OA患者。所有患者每天服用5毫克瑞舒伐他汀/10毫克依折麦布。主要终点是12周时低密度脂蛋白胆固醇（LDL-C）较基线降低≥50%。
该研究招募了162例RA患者和119例OA患者，其中143例RA患者和107例OA患者完成随访并纳入最终分析。与OA组相比，RA组年龄更大，女性更多，体重指数更低，C反应蛋白水平更高。RA组79.7%的患者和OA组70.1%的患者达到了LDL-C较基线降低≥50%的主要终点（P = 0.1086）。在安全性终点方面未发现显著差异。在单变量线性回归分析中，基线LDL-C水平与LDL-C的绝对降低相关。在多变量分析中，这种关联仍然显著。RA的28关节疾病活动评分与红细胞沉降率、C反应蛋白水平、年龄、体重指数、当前吸烟状况、高血压、糖尿病和每日糖皮质激素剂量均无显著关联。
低剂量瑞舒伐他汀/依折麦布降低LDL-C水平的疗效和安全性在RA组和OA组中相似。基线LDL-C水平是与LDL-C降低相关的唯一独立因素，与炎症状态无关。
