Safety and efficacy of lithium in patients with amyotrophic lateral sclerosis: a systematic review and meta-analysis of randomized controlled trials.
Amyotrophic lateral sclerosis
Lithium
Meta-analysis
Motor neuron disease
Journal
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
ISSN: 1590-3478
Titre abrégé: Neurol Sci
Pays: Italy
ID NLM: 100959175
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
received:
31
01
2023
accepted:
10
04
2023
medline:
11
8
2023
pubmed:
18
4
2023
entrez:
17
4
2023
Statut:
ppublish
Résumé
This study provides a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the safety and efficacy of lithium in amyotrophic lateral sclerosis (ALS) patients. PubMed, Web of Science, Cochrane CENTRAL, Scopus, and Your Journals@Ovid were searched up to 9 December 2022. RCTs investigating lithium, either alone or with any supplement, in ALS patients were included. Meta-analysis was performed using RevMan and results are presented in forest plot. Four RCTs with 469 patients met the inclusion criteria and were included in our study. Lithium doses varied among the included studies and one study used a combined therapy of lithium with valproate. Meta-analysis showed no difference between lithium and placebo regarding severe adverse events (odds ratio = 1.13, 95% confidence interval: 0.73 to 1.75, P = 0.58). No significant differences were observed with regard to survival rate between the two groups (hazard ratio = 0.95, 95% confidence interval: 0.65 to 1.37, P = 0.77). There were also no significant differences between the two groups with regard to average changes of revised amyotrophic lateral sclerosis functional rating scale (P = 0.35) and forced vital capacity percentage predicted (P = 0.73). Subgroup analysis showed no significant differences regarding all investigated outcomes either for lithium alone or lithium with valproate. Current evidence suggests a safety profile with no benefit of lithium for ALS. However, given the limited number of RCTs and the safety findings, we recommend further well-designed RCTs to investigate lithium and valproate in ALS patients.
Identifiants
pubmed: 37069469
doi: 10.1007/s10072-023-06814-9
pii: 10.1007/s10072-023-06814-9
doi:
Substances chimiques
Lithium
9FN79X2M3F
Valproic Acid
614OI1Z5WI
Types de publication
Meta-Analysis
Systematic Review
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
3029-3036Informations de copyright
© 2023. Fondazione Società Italiana di Neurologia.
Références
Hardiman O, Al-Chalabi A, Chio A et al (2017) Amyotrophic lateral sclerosis [published correction appears in Nat Rev Dis Primers. 2017 Oct 20;3:17085]. Nat Rev Dis Primers 3:17071. Published 2017 Oct 5. https://doi.org/10.1038/nrdp.2017.71
Mehta P, Horton DK, Kasarskis EJ et al (2017) CDC Grand Rounds: National Amyotrophic Lateral Sclerosis (ALS) Registry Impact, Challenges, and Future Directions [published correction appears in MMWR Morb Mortal Wkly Rep. 2018 Jan 19;67(2):81]. MMWR Morb Mortal Wkly Rep 66(50):1379–1382. Published 2017 Dec 22. https://doi.org/10.15585/mmwr.mm6650a3
Bettencourt C, Houlden H (2015) Exome sequencing uncovers hidden pathways in familial and sporadic ALS. Nat Neurosci 18(5):611–613. https://doi.org/10.1038/nn.4012
doi: 10.1038/nn.4012
pubmed: 25919956
Brown CA, Lally C, Kupelian V, Flanders WD (2021) Estimated Prevalence and Incidence of Amyotrophic Lateral Sclerosis and SOD1 and C9orf72 Genetic Variants. Neuroepidemiology 55(5):342–353. https://doi.org/10.1159/000516752
doi: 10.1159/000516752
pubmed: 34247168
Bensimon G, Lacomblez L, Meininger V (1994) A controlled trial of riluzole in amyotrophic lateral sclerosis. ALS/Riluzole Study Group. N Engl J Med 330(9):585–591. https://doi.org/10.1056/NEJM199403033300901
Lacomblez L, Bensimon G, Leigh PN, Guillet P, Meininger V (1996) Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis/Riluzole Study Group II. Lancet 347(9013):1425–1431. https://doi.org/10.1016/s0140-6736(96)91680-3
Writing Group; Edaravone (MCI-186) ALS 19 Study Group (2017) Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 16(7):505–512. https://doi.org/10.1016/S1474-4422(17)30115-1
Paganoni S, Macklin EA, Hendrix S et al (2020) Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis. N Engl J Med 383(10):919–930. https://doi.org/10.1056/NEJMoa1916945
doi: 10.1056/NEJMoa1916945
pmcid: 9134321
Nivoli AM, Colom F, Murru A et al (2011) New treatment guidelines for acute bipolar depression: a systematic review. J Affect Disord 129(1–3):14–26. https://doi.org/10.1016/j.jad.2010.05.018
doi: 10.1016/j.jad.2010.05.018
pubmed: 20538341
Pasquali L, Busceti CL, Fulceri F, Paparelli A, Fornai F (2010) Intracellular pathways underlying the effects of lithium. Behav Pharmacol 21(5–6):473–492. https://doi.org/10.1097/FBP.0b013e32833da5da
doi: 10.1097/FBP.0b013e32833da5da
pubmed: 20700048
Won E, Kim YK (2017) An Oldie but Goodie: Lithium in the Treatment of Bipolar Disorder through Neuroprotective and Neurotrophic Mechanisms. Int J Mol Sci. 18(12):2679. Published 2017 Dec 11. https://doi.org/10.3390/ijms18122679
Chalecka-Franaszek E, Chuang DM (1999) Lithium activates the serine/threonine kinase Akt-1 and suppresses glutamate-induced inhibition of Akt-1 activity in neurons. Proc Natl Acad Sci U S A 96(15):8745–8750. https://doi.org/10.1073/pnas.96.15.8745
doi: 10.1073/pnas.96.15.8745
pubmed: 10411946
pmcid: 17587
Hashimoto R, Senatorov V, Kanai H, Leeds P, Chuang DM (2003) Lithium stimulates progenitor proliferation in cultured brain neurons. Neuroscience 117(1):55–61. https://doi.org/10.1016/s0306-4522(02)00577-8
doi: 10.1016/s0306-4522(02)00577-8
pubmed: 12605892
Hashimoto R, Takei N, Shimazu K, Christ L, Lu B, Chuang DM (2002) Lithium induces brain-derived neurotrophic factor and activates TrkB in rodent cortical neurons: an essential step for neuroprotection against glutamate excitotoxicity. Neuropharmacology 43(7):1173–1179. https://doi.org/10.1016/s0028-3908(02)00217-4
doi: 10.1016/s0028-3908(02)00217-4
pubmed: 12504924
Feng HL, Leng Y, Ma CH, Zhang J, Ren M, Chuang DM (2008) Combined lithium and valproate treatment delays disease onset, reduces neurological deficits and prolongs survival in an amyotrophic lateral sclerosis mouse model. Neuroscience 155(3):567–572. https://doi.org/10.1016/j.neuroscience.2008.06.040
doi: 10.1016/j.neuroscience.2008.06.040
pubmed: 18640245
Dill J, Wang H, Zhou F, Li S (2008) Inactivation of glycogen synthase kinase 3 promotes axonal growth and recovery in the CNS. J Neurosci 28(36):8914–8928. https://doi.org/10.1523/JNEUROSCI.1178-08.2008
doi: 10.1523/JNEUROSCI.1178-08.2008
pubmed: 18768685
pmcid: 6670875
Vallée A, Vallée JN, Lecarpentier Y (2021) Parkinson's Disease: Potential Actions of Lithium by Targeting the WNT/β-Catenin Pathway, Oxidative Stress, Inflammation and Glutamatergic Pathway. Cells 10(2):230. Published 2021 Jan 25. https://doi.org/10.3390/cells10020230
Lazzara CA, Kim YH (2015) Potential application of lithium in Parkinson's and other neurodegenerative diseases. Front Neurosci 9:403. Published 2015 Oct 27. https://doi.org/10.3389/fnins.2015.00403
Fornai F, Longone P, Cafaro L et al (2008) Lithium delays progression of amyotrophic lateral sclerosis [published correction appears in Proc Natl Acad Sci U S A. 2008 Oct 21;105(42):16404–7]. Proc Natl Acad Sci U S A 105(6):2052–2057. https://doi.org/10.1073/pnas.0708022105
Aggarwal SP, Zinman L, Simpson E et al (2010) Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 9(5):481–488. https://doi.org/10.1016/S1474-4422(10)70068-5
doi: 10.1016/S1474-4422(10)70068-5
pubmed: 20363190
pmcid: 3071495
Boll MC, Alcaraz-Zubeldia M, Rios C, González-Esquivel D, Montes S (2022) A phase 2, double-blind, placebo-controlled trial of a valproate/lithium combination in ALS patients [published online ahead of print, 2022 Aug 29]. Neurologia (Engl Ed) S2173–5808(22)00089-X. https://doi.org/10.1016/j.nrleng.2022.07.003
Willemse SW, Roes KCB, Van Damme P et al (2022) Lithium carbonate in amyotrophic lateral sclerosis patients homozygous for the C-allele at SNP rs12608932 in UNC13A: protocol for a confirmatory, randomized, group-sequential, event-driven, double-blind, placebo-controlled trial. Trials 23(1):978. https://doi.org/10.1186/s13063-022-06906-5
doi: 10.1186/s13063-022-06906-5
pubmed: 36471413
pmcid: 9721045
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535. Published 2009 Jul 21. https://doi.org/10.1136/bmj.b2535
Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases (2000) El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord 1(5):293–299. https://doi.org/10.1080/146608200300079536
Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A (2016) Rayyan-a web and mobile app for systematic reviews. Syst Rev 5(1):210. Published 2016 Dec 5. https://doi.org/10.1186/s13643-016-0384-4
Altman DG, Bland JM (2011) How to obtain the confidence interval from a P value. BMJ 343:d2090. Published 2011 Aug 8. https://doi.org/10.1136/bmj.d2090
Sterne JAC, Savović J, Page MJ et al (2019) RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 366:l4898. Published 2019 Aug 28. https://doi.org/10.1136/bmj.l4898
Verstraete E, Veldink JH, Huisman MH et al (2012) Lithium lacks effect on survival in amyotrophic lateral sclerosis: a phase IIb randomised sequential trial. J Neurol Neurosurg Psychiatry 83(5):557–564. https://doi.org/10.1136/jnnp-2011-302021
doi: 10.1136/jnnp-2011-302021
pubmed: 22378918
UKMND-LiCALS Study Group, Morrison KE, Dhariwal S et al (2013) Lithium in patients with amyotrophic lateral sclerosis (LiCALS): a phase 3 multicentre, randomised, double-blind, placebo-controlled trial [published correction appears in Lancet Neurol. 2013 Sep;12(9):846]. Lancet Neurol 12(4):339–345. https://doi.org/10.1016/S1474-4422(13)70037-1
van Harten PN, Hoek HW, Matroos GE, van Os J (2008) Evidence that lithium protects against tardive dyskinesia: the Curaçao Extrapyramidal syndromes study VI. Eur Neuropsychopharmacol 18(2):152–155. https://doi.org/10.1016/j.euroneuro.2007.07.004
doi: 10.1016/j.euroneuro.2007.07.004
pubmed: 17822885
Straten G, Saur R, Laske C et al (2011) Influence of lithium treatment on GDNF serum and CSF concentrations in patients with early Alzheimer’s disease. Curr Alzheimer Res 8(8):853–859. https://doi.org/10.2174/156720511798192754
doi: 10.2174/156720511798192754
pubmed: 21875410
Berk M, Dandash O, Daglas R et al (2017) Neuroprotection after a first episode of mania: a randomized controlled maintenance trial comparing the effects of lithium and quetiapine on grey and white matter volume [published correction appears in Transl Psychiatry. 2017 Feb 21;7(2):e1041]. Transl Psychiatry 7(1):e1011. https://doi.org/10.1038/tp.2016.281
Miller RG, Moore DH, Forshew DA et al (2011) Phase II screening trial of lithium carbonate in amyotrophic lateral sclerosis: examining a more efficient trial design. Neurology 77(10):973–979. https://doi.org/10.1212/WNL.0b013e31822dc7a5
doi: 10.1212/WNL.0b013e31822dc7a5
pubmed: 21813790
pmcid: 3171956
Wicks P, Vaughan TE, Massagli MP, Heywood J (2011) Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm. Nat Biotechnol 29(5):411–414. https://doi.org/10.1038/nbt.1837
doi: 10.1038/nbt.1837
pubmed: 21516084
Chiò A, Borghero G, Calvo A et al (2010) Lithium carbonate in amyotrophic lateral sclerosis: lack of efficacy in a dose-finding trial. Neurology 75(7):619–625. https://doi.org/10.1212/WNL.0b013e3181ed9e7c
doi: 10.1212/WNL.0b013e3181ed9e7c
pubmed: 20702794
van Eijk RPA, Jones AR, Sproviero W et al (2017) Meta-analysis of pharmacogenetic interactions in amyotrophic lateral sclerosis clinical trials [published correction appears in Neurology. 2017 Nov 28;89(22):2303]. Neurology 89(18):1915–1922. https://doi.org/10.1212/WNL.0000000000004606