Monash University, Melbourne, Victoria, Australia.
University of Tasmania, Hobart, Tasmania, Australia.
Arthritis Rheumatol. 2021 Nov;73(11):2035-2043. doi: 10.1002/art.41760. Epub 2021 Sep 27.
To determine whether atorvastatin slows tibial cartilage volume loss in patients with symptomatic knee osteoarthritis (OA) in a multicenter, randomized, double-blind, placebo-controlled trial.
Participants ages 40-70 years were randomized to receive oral atorvastatin (40 mg once daily) (n = 151) or matching placebo (n = 153). The primary end point was annual percentage change in tibial cartilage volume over 2 years, assessed using magnetic resonance imaging (MRI). The prespecified secondary end points were progression of cartilage defects and bone marrow lesions over 2 years, which were assessed using MRI and change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index pain, stiffness, and function scores.
A total of 248 of 304 participants (81.6%) completed the trial (mean age 55.7 years; 55.6% women). The annual change in tibial cartilage volume differed minimally between the atorvastatin and placebo groups (mean change -1.66% versus -2.17%, between-group difference 0.50% [95% confidence interval (95% CI) -0.17%, 1.17%]). There were no significant differences in the progression of cartilage defects (odds ratio [OR] 0.86 [95% CI 0.52, 1.41]) or progression of bone marrow lesions (OR 1.00 [95% CI 0.62, 1.63]). Moreover, there were no significant differences in change in WOMAC pain, stiffness, or function scores over 2 years between the atorvastatin and placebo groups (mean change in pain score -36.0 versus -29.5, adjusted difference -2.7 [95% CI -27.1, 21.7]; mean change in stiffness score -14.2 versus -11.8, adjusted difference -0.2 [95% CI -12.2, 11.8]; mean change in function score -89.4 versus -87.5, adjusted difference 0.3 [95% CI -83.1, 83.6]). The incidence of adverse events (AEs) was similar between the atorvastatin and placebo groups (57 [37.7%] versus 52 [34.0%] experiencing AEs).
Treatment with oral atorvastatin (40 mg once daily), compared to placebo, did not significantly reduce cartilage volume loss over 2 years in patients with symptomatic knee OA. These findings do not support the use of atorvastatin for the treatment of knee OA.
在一项多中心、随机、双盲、安慰剂对照试验中，确定阿托伐他汀是否能减缓有症状的膝骨关节炎（OA）患者的胫骨软骨体积损失。
参与者年龄在 40-70 岁之间，随机接受口服阿托伐他汀（40mg 每日一次）（n=151）或匹配的安慰剂（n=153）。主要终点是 2 年内胫骨软骨体积的年百分比变化，使用磁共振成像（MRI）评估。预设的次要终点是 2 年内软骨缺损和骨髓病变的进展，使用 MRI 和 Western Ontario 和 McMaster 大学骨关节炎（WOMAC）指数疼痛、僵硬和功能评分的变化来评估。
共有 304 名参与者中的 248 名（81.6%）完成了试验（平均年龄 55.7 岁；55.6%为女性）。阿托伐他汀组和安慰剂组之间胫骨软骨体积的年变化差异极小（平均变化-1.66%与-2.17%，组间差异 0.50%[95%置信区间（95%CI）-0.17%，1.17%]）。软骨缺损的进展（比值比[OR]0.86[95%CI 0.52，1.41]）或骨髓病变的进展（OR 1.00[95%CI 0.62，1.63]）均无显著差异。此外，阿托伐他汀组和安慰剂组在 2 年内 WOMAC 疼痛、僵硬或功能评分的变化也无显著差异（疼痛评分的平均变化-36.0 与-29.5，调整差异-2.7[95%CI-27.1，21.7]；僵硬评分的平均变化-14.2 与-11.8，调整差异-0.2[95%CI-12.2，11.8]；功能评分的平均变化-89.4 与-87.5，调整差异 0.3[95%CI-83.1，83.6]）。阿托伐他汀组和安慰剂组的不良事件（AE）发生率相似（57[37.7%]与 52[34.0%]发生 AE）。
与安慰剂相比，口服阿托伐他汀（40mg 每日一次）治疗在 2 年内并未显著减少有症状膝骨关节炎患者的软骨体积损失。这些发现不支持使用阿托伐他汀治疗膝骨关节炎。
