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Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial
McKee, Justin B.1,2; Cottriall, Charles L.3; Elston, John3; Epps, Simon4; Evangelou, Nikos5; Gerry, Stephen6; Kennard, Christopher7; Kong, Yazhuo8,9; Koelewyn, Abigail1; Kueker, Wilhelm10; Leite, Maria Isabel1; Palace, Jacqueline1; Craner, Matthew1
第一作者McKee, Justin B.
通讯作者邮箱m craner(matthew.craner@ndcn.ox.ac.uk)
摘要

Background: Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel (ASIC). Objective: To examine the neuroprotective efficacy of amiloride in acute optic neuritis (ON). Methods: A total of 48 patients were recruited to a phase 2, double blind, single site, randomised controlled trial. Scanning laser polarimetry (GDx) at 6 months was the primary outcome measure and optical coherence tomography (OCT) and visual and electrophysiological measures were secondary outcome measures. Participants aged 18-55 years, <= 28 days of onset of first episode unilateral ON, were randomised to amiloride (10 mg daily for 5 months) or placebo (, NCT 01802489). Results: Intention-to-treat (ITT) cohort consisted of 43 patients; 23 placebo and 20 amiloride. No significant drug-related adverse events occurred. No significant differences were found in GDx (p = 0.840). Visual evoked potentials (VEP) were significantly prolonged in the amiloride group compared to placebo (p = 0.004). All other secondary outcome measures showed no significant difference. Baseline analysis of OCT data demonstrated a significant pre-randomisation thinning of ganglion cell layer. Conclusion: Amiloride has not demonstrated any neuroprotective benefit within this trial paradigm, but future neuroprotective trials in ON should target the window of opportunity to maximise potential neuroprotective benefit.

关键词Clinical trial outcome measurement multiple sclerosis axonal loss
2019-02-01
语种英语
DOI10.1177/1352458517742979
发表期刊MULTIPLE SCLEROSIS JOURNAL
ISSN1352-4585
卷号25期号:2页码:246-255
期刊论文类型article
收录类别SCI
资助项目Multiple Sclerosis Society in the UK[952/11]
出版者SAGE PUBLICATIONS LTD
WOS关键词MULTIPLE-SCLEROSIS ; NEUROPROTECTION ; BRAIN ; MECHANISMS ; INJURY ; RISK
WOS研究方向Neurosciences & Neurology
WOS类目Clinical Neurology ; Neurosciences
WOS记录号WOS:000457648700012
引用统计
被引频次:12[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.psych.ac.cn/handle/311026/28314
专题认知与发展心理学研究室
通讯作者Craner, Matthew
作者单位1.Univ Oxford, John Radcliffe Hosp, Nuffield Dept Clin Neurosci, Div Clin Neurol, Oxford, England
2.NHS Lothian, Princess Alexandra Eye Pavil, Edinburgh, Midlothian, Scotland
3.Oxford Univ Hosp NHS Fdn Trust, Oxford Eye Hosp, Oxford, England
4.Univ Bristol, Sch Clin Sci, Ophthalmol, Bristol, Avon, England
5.Univ Nottingham, Fac Med & Hlth Sci, Nottingham, England
6.Univ Oxford, Ctr Stat Med, Oxford, England
7.Univ Oxford, John Radcliffe Hosp, Med Sci Div, Oxford, England
8.Univ Oxford, Nuffield Dept Clin Neurosci, Oxford Ctr Funct Magnet Resonance Imaging Brain F, Oxford, England
9.Chinese Acad Sci, Inst Psychol, Beijing, Peoples R China
10.Oxford Univ Hosp NHS Fdn Trust, John Radcliffe Hosp, Dept Neuroradiol, Oxford, England
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GB/T 7714
McKee, Justin B.,Cottriall, Charles L.,Elston, John,et al. Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial[J]. MULTIPLE SCLEROSIS JOURNAL,2019,25(2):246-255.
APA McKee, Justin B..,Cottriall, Charles L..,Elston, John.,Epps, Simon.,Evangelou, Nikos.,...&Craner, Matthew.(2019).Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial.MULTIPLE SCLEROSIS JOURNAL,25(2),246-255.
MLA McKee, Justin B.,et al."Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial".MULTIPLE SCLEROSIS JOURNAL 25.2(2019):246-255.
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