Lanzillo Roberta, Quarantelli Mario, Pozzilli Carlo, Trojano Maria, Amato Maria Pia, Marrosu Maria G, Francia Ada, Florio Ciro, Orefice Giuseppe, Tedeschi Gioacchino, Bellantonio Paolo, Annunziata Pasquale, Grimaldi Luigi M, Comerci Marco, Brunetti Arturo, Bonavita Vincenzo, Alfano Bruno, Marini Stefano, Brescia Morra Vincenzo
Department of Neurosciences, Reproductive and Odontostomatological Sciences, Federico II University of Naples, Italy
National Research Council (CNR) Biostructure and Bioimaging Institute (IBB), Naples Multiple Sclerosis Centre, Italy.
Mult Scler. 2016 Aug;22(9):1163-73. doi: 10.1177/1352458515611222. Epub 2015 Oct 14.
A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis.
The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing-remitting multiple sclerosis.
This randomised, placebo-controlled study compared atorvastatin 40 mg or placebo add-on therapy to interferon β1b for 24 months. Brain magnetic resonance imaging, multiple sclerosis functional composite score, Rao neuropsychological battery and expanded disability status scale were evaluated over 24 months.
A total of 154 patients were randomly assigned, 75 in the atorvastatin and 79 in the placebo arms, with a comparable drop-out rate (overall 23.4%). Brain atrophy over 2 years was not different in the two arms (-0.38% and -0.32% for the atorvastatin and placebo groups, respectively). Relapse rate, expanded disability status scale, multiple sclerosis functional composite score or cognitive changes were not different in the two arms. Patients withdrawing from the study had a higher number of relapses in the previous 2 years (P=0.04) and a greater probability of relapsing within 12 months.
Our results suggest that the combination of atorvastatin and interferon β1b is not justified in early relapsing-remitting multiple sclerosis and adds to the body of evidence indicating an absence of significant radiological and clinical benefit of statins in relapsing-remitting multiple sclerosis.
先前的一项2期试验表明，他汀类药物可能会延缓继发进展型多发性硬化症的脑萎缩。
本研究的目的是评估阿托伐他汀附加疗法对复发缓解型多发性硬化症脑萎缩的影响。
这项随机、安慰剂对照研究比较了阿托伐他汀40mg或安慰剂附加疗法联合干扰素β1b治疗24个月的效果。在24个月内评估脑磁共振成像、多发性硬化症功能综合评分、饶氏神经心理成套测验和扩展残疾状态量表。
共有154例患者被随机分配，75例接受阿托伐他汀治疗，79例接受安慰剂治疗，两组的脱落率相当（总体为23.4%）。两组在2年内的脑萎缩情况无差异（阿托伐他汀组和安慰剂组分别为-0.38%和-0.32%）。两组的复发率、扩展残疾状态量表、多发性硬化症功能综合评分或认知变化均无差异。退出研究的患者在过去2年中的复发次数更多（P=0.04），且在12个月内复发的可能性更大。
我们的结果表明，在早期复发缓解型多发性硬化症中，阿托伐他汀与干扰素β1b联合使用并不合理，这进一步证明了他汀类药物在复发缓解型多发性硬化症中没有显著的影像学和临床益处。
