Second Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece; Department of Neurology & Stroke, Hertie-Institute for Clinical Brain Research, Eberhard-Karls University of Tübingen, Tübingen, Germany.
Second Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Mult Scler Relat Disord. 2022 Feb;58:103395. doi: 10.1016/j.msard.2021.103395. Epub 2021 Nov 10.
To assess whether statins (3‑hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) exert disease-modifying effects in multiple sclerosis (MS).
A systematic review and meta-analysis was performed including randomized-controlled clinical trials (RCTs) on statin use in MS. A random-effects model was applied to calculate pooled estimates and odds ratios (ORs) with corresponding 95% confidence intervals (CIs), when comparing patients treated with statins alone or adjunct to disease modifying treatment (DMT) to non-statin-treated patients.
We identified 7 RCTs including 789 patients with relapsing-remitting MS (RRMS), all of whom received additional DMT with IFN-β. Single identified RCTs in secondary-progressive MS (SPMS), clinically isolated syndrome (CIS) and optic neuritis (ON) were not meta-analyzed. In RRMS, add-on statin use was not associated with the risk of clinical relapse (OR=1.30, 95%CI: 0.901.87) or EDSS-progression from baseline, neither appeared related to the risk of new contrast-enhancing or T2 lesions (OR=1.28, 95%CI: 0.364.58), and the risk of whole-brain volume reduction on MRI. Add-on statins to IFN-β were safe and well-tolerated. In SPMS, stand-alone simvastatin led to significantly reduced annualized rate of whole-brain volume reduction. In CIS and ON, statins were associated with reduced risk for new T2 lesions and improved visual recovery, respectively.
We detected no benefit from statin treatment as add-on to IFN-β in RRMS. However, a potential beneficial effect in SPMS, CIS and ON deserves independent confirmation and further evaluation within adequately powered RCTs.
评估他汀类药物（3-羟基-3-甲基戊二酰辅酶 A 还原酶抑制剂）是否对多发性硬化症（MS）具有疾病修饰作用。
系统评价和荟萃分析纳入了关于 MS 患者使用他汀类药物的随机对照临床试验（RCT）。应用随机效应模型计算汇总估计值和比值比（OR）及其相应的 95%置信区间（CI），比较单独使用他汀类药物或联合疾病修正治疗（DMT）与未使用他汀类药物的患者。
我们确定了 7 项 RCT，共纳入 789 例复发缓解型多发性硬化症（RRMS）患者，所有患者均接受了 IFN-β 的附加 DMT。单独在继发进展型多发性硬化症（SPMS）、临床孤立综合征（CIS）和视神经炎（ON）中确定的 RCT 未进行荟萃分析。在 RRMS 中，他汀类药物的附加使用与临床复发的风险无关（OR=1.30，95%CI：0.901.87）或从基线开始的 EDSS 进展，也与新的对比增强或 T2 病变的风险无关（OR=1.28，95%CI：0.364.58），以及 MRI 上全脑容积减少的风险。IFN-β 附加他汀类药物是安全且耐受良好的。在 SPMS 中，单独使用辛伐他汀可显著降低全脑容积减少的年发生率。在 CIS 和 ON 中，他汀类药物与降低新 T2 病变风险和改善视力恢复相关。
我们未发现他汀类药物作为 IFN-β 的附加治疗在 RRMS 中的获益。然而，SPMS、CIS 和 ON 中的潜在有益作用值得独立确认，并在充分有力的 RCT 中进一步评估。
