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Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial

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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.; Cottriall, Charles L.; Elston, John; Epps, Simon; Evangelou, Nikos; Gerry, Stephen; Kennard, Christopher; Kong, Yazhuo; Koelewyn, Abigail; Kueker, Wilhelm; Leite, Maria Isabel; Palace, Jacqueline; Craner, Matthew.

In: Multiple Sclerosis Journal, Vol. 25, No. 2, 01.02.2019, p. 246-255.

Research output: Contribution to journalArticle

Harvard

McKee, JB, Cottriall, CL, Elston, J, Epps, S, Evangelou, N, Gerry, S, Kennard, C, Kong, Y, Koelewyn, A, Kueker, W, Leite, MI, Palace, J & Craner, M 2019, 'Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial', Multiple Sclerosis Journal, vol. 25, no. 2, pp. 246-255. https://doi.org/10.1177/1352458517742979

APA

McKee, J. B., Cottriall, C. L., Elston, J., Epps, S., Evangelou, N., Gerry, S., ... Craner, M. (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. https://doi.org/10.1177/1352458517742979

Vancouver

McKee JB, Cottriall CL, Elston J, Epps S, Evangelou N, Gerry S et al. Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial. Multiple Sclerosis Journal. 2019 Feb 1;25(2):246-255. https://doi.org/10.1177/1352458517742979

Author

McKee, Justin B. ; Cottriall, Charles L. ; Elston, John ; Epps, Simon ; Evangelou, Nikos ; Gerry, Stephen ; Kennard, Christopher ; Kong, Yazhuo ; Koelewyn, Abigail ; Kueker, Wilhelm ; Leite, Maria Isabel ; Palace, Jacqueline ; Craner, Matthew. / Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial. In: Multiple Sclerosis Journal. 2019 ; Vol. 25, No. 2. pp. 246-255.

Bibtex

@article{1e78d97669654286acdb22a1461d88b7,
title = "Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial",
abstract = "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 (clinicaltrials.gov, 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.",
keywords = "axonal loss, Clinical trial, multiple sclerosis, outcome measurement",
author = "McKee, {Justin B.} and Cottriall, {Charles L.} and John Elston and Simon Epps and Nikos Evangelou and Stephen Gerry and Christopher Kennard and Yazhuo Kong and Abigail Koelewyn and Wilhelm Kueker and Leite, {Maria Isabel} and Jacqueline Palace and Matthew Craner",
year = "2019",
month = "2",
day = "1",
doi = "10.1177/1352458517742979",
language = "English",
volume = "25",
pages = "246--255",
journal = "Multiple Sclerosis Journal",
issn = "1352-4585",
publisher = "SAGE Publications Ltd",
number = "2",

}

RIS - suitable for import to EndNote

TY - JOUR

T1 - Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial

AU - McKee, Justin B.

AU - Cottriall, Charles L.

AU - Elston, John

AU - Epps, Simon

AU - Evangelou, Nikos

AU - Gerry, Stephen

AU - Kennard, Christopher

AU - Kong, Yazhuo

AU - Koelewyn, Abigail

AU - Kueker, Wilhelm

AU - Leite, Maria Isabel

AU - Palace, Jacqueline

AU - Craner, Matthew

PY - 2019/2/1

Y1 - 2019/2/1

N2 - 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 (clinicaltrials.gov, 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.

AB - 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 (clinicaltrials.gov, 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.

KW - axonal loss

KW - Clinical trial

KW - multiple sclerosis

KW - outcome measurement

UR - http://www.scopus.com/inward/record.url?scp=85043307784&partnerID=8YFLogxK

U2 - 10.1177/1352458517742979

DO - 10.1177/1352458517742979

M3 - Article

C2 - 29172994

AN - SCOPUS:85043307784

VL - 25

SP - 246

EP - 255

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

SN - 1352-4585

IS - 2

ER -