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Article ; Online: Lipase C, Hepatic Type -250A/G (rs2070895) Variant Enhances Carotid Atherosclerosis in Normolipidemic and Asymptomatic Individuals from Brazil.

Zago, Vanessa H S / Parra, Eliane S / Virgínio, Vítor W M / Vendrame, Felipe / Gomes, Érica I L / Scherrer, Daniel Z / Marson, Fernando A L / de Faria, Eliana C

Lipids

2020 Volume 55, Issue 3, Page(s) 225–237

Abstract: The common genetic variant in the promoter region of the hepatic lipase gene [LIPC -250G/A(rs2070895)] has an ambiguous association with cardiovascular disease. In this context, our study was performed to identify the relationships between the rs2070895 ... ...

Abstract	The common genetic variant in the promoter region of the hepatic lipase gene [LIPC -250G/A(rs2070895)] has an ambiguous association with cardiovascular disease. In this context, our study was performed to identify the relationships between the rs2070895 with carotid atherosclerosis, plasma lipids, and parameters of reverse cholesterol transport. A total of 285 normolipidemic and asymptomatic participants from an initial sample of 598,288 individuals (inclusion criteria: LDL-C ≤130 mg/dL and triglycerides ≤150 mg/dL; age: 20-75 years, both genders; confirmation of clinical, anthropometric and laboratory data; attended all visits; DNA was achieved to perform genetic analysis) were enrolled and the rs2070895 variant was genotyped by TaqMan® OpenArray® Plataform. Carotid intima-media thickness and the screening of atherosclerotic plaques were determined by B-mode ultrasonography. The rs2070895 genotype frequencies were 0.44, 0.41, and 0.15 (GG, GA, and AA, respectively). Logistic regression analysis showed that the risk of having plaques was increased in participants carrying the AA or AG genotypes (OR = 3.90; 95% CI = 1.54-10.33), despite an increase in high-density lipoprotein cholesterol levels, HDL diameter and apolipoprotein A-I, as compared to the GG genotype. Hepatic lipase and endogenous lecithin cholesterol acyl transferase activities were reduced (38% and 19%, respectively) and lipoprotein lipase was increased by 30% (AA vs GG). Our results provide evidence that the AA or AG genotypes of the rs2070895 were associated with carotid atherosclerosis in apparently healthy participants, probably as a consequence of reduced reverse cholesterol transport and accumulation of HDL subfraction 2 rich in triglycerides and depleted in cholesteryl esters that could become dysfunctional.
MeSH term(s)	Adult ; Aged ; Asymptomatic Diseases ; Brazil ; Carotid Artery Diseases/blood ; Carotid Artery Diseases/genetics ; Cholesterol/blood ; Female ; Genetic Association Studies ; Humans ; Lipase/genetics ; Lipids/blood ; Male ; Middle Aged ; Polymorphism, Single Nucleotide ; Young Adult
Chemical Substances	LIPC protein, human ; Lipids ; Cholesterol (97C5T2UQ7J) ; Lipase (EC 3.1.1.3)
Language	English
Publishing date	2020-03-20
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	241539-2
ISSN	1558-9307 ; 0024-4201
ISSN (online)	1558-9307
ISSN	0024-4201
DOI	10.1002/lipd.12232
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Article: Lipase C, Hepatic Type −250A/G (rs2070895) Variant Enhances Carotid Atherosclerosis in Normolipidemic and Asymptomatic Individuals from Brazil

Zago, Vanessa H. S. / Parra, Eliane S. / Virgínio, Vítor W. M. / Vendrame, Felipe / Gomes, Érica I. L. / Scherrer, Daniel Z. / Marson, Fernando A. L. / de Faria, Eliana C.

Lipids. 2020 May, v. 55, no. 3

2020

Abstract: The common genetic variant in the promoter region of the hepatic lipase gene [LIPC −250G/A(rs2070895)] has an ambiguous association with cardiovascular disease. In this context, our study was performed to identify the relationships between the rs2070895 ... ...

Abstract	The common genetic variant in the promoter region of the hepatic lipase gene [LIPC −250G/A(rs2070895)] has an ambiguous association with cardiovascular disease. In this context, our study was performed to identify the relationships between the rs2070895 with carotid atherosclerosis, plasma lipids, and parameters of reverse cholesterol transport. A total of 285 normolipidemic and asymptomatic participants from an initial sample of 598,288 individuals (inclusion criteria: LDL‐C ≤130 mg/dL and triglycerides ≤150 mg/dL; age: 20–75 years, both genders; confirmation of clinical, anthropometric and laboratory data; attended all visits; DNA was achieved to perform genetic analysis) were enrolled and the rs2070895 variant was genotyped by TaqMan® OpenArray® Plataform. Carotid intima‐media thickness and the screening of atherosclerotic plaques were determined by B‐mode ultrasonography. The rs2070895 genotype frequencies were 0.44, 0.41, and 0.15 (GG, GA, and AA, respectively). Logistic regression analysis showed that the risk of having plaques was increased in participants carrying the AA or AG genotypes (OR = 3.90; 95% CI = 1.54–10.33), despite an increase in high‐density lipoprotein cholesterol levels, HDL diameter and apolipoprotein A‐I, as compared to the GG genotype. Hepatic lipase and endogenous lecithin cholesterol acyl transferase activities were reduced (38% and 19%, respectively) and lipoprotein lipase was increased by 30% (AA vs GG). Our results provide evidence that the AA or AG genotypes of the rs2070895 were associated with carotid atherosclerosis in apparently healthy participants, probably as a consequence of reduced reverse cholesterol transport and accumulation of HDL subfraction 2 rich in triglycerides and depleted in cholesteryl esters that could become dysfunctional.
Keywords	DNA ; apolipoprotein A-I ; atherosclerosis ; genes ; genetic analysis ; genotype ; genotyping ; high density lipoprotein cholesterol ; lecithins ; lipoprotein lipase ; promoter regions ; regression analysis ; risk ; ultrasonography ; Brazil
Language	English
Dates of publication	2020-05
Size	p. 225-237.
Publishing place	John Wiley & Sons, Inc.
Document type	Article
Note	JOURNAL ARTICLE
ZDB-ID	241539-2
ISSN	1558-9307 ; 0024-4201
ISSN (online)	1558-9307
ISSN	0024-4201
DOI	10.1002/lipd.12232
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Article: Spontaneous splenic rupture following stem cell mobilization with G-CSF and plerixafor in AL amyloidosis.

Lessi, Federica / Marson, Piero / Colpo, Anna / Marino, Filippo / Branca, Antonio / Tison, Tiziana / Adami, Fausto

Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis

2015 Volume 54, Issue 2, Page(s) 256–258

Abstract: ... splenic rupture following administration of G-CSF and plerixafor in a patient with AL amyloidosis who previously ... the first report of spontaneous splenic rupture following stem cell mobilization with G-CSF and plerixafor ...

Abstract	Background: AL amyloidosis is a rare plasma cell dyscrasia with multiorgan involvement. Good risk patients are candidate to high dose chemotherapy and autologous stem cell transplantation. However both transplantation and stem cell collection entail significant risk in such patients. Plerixafor is a novel mobilizing agent approved for use in "poor mobilizer" patients with lymphoma and multiple myeloma; experience in systemic amyloidosis patients is limited. Case report: We describe a case of spontaneous splenic rupture following administration of G-CSF and plerixafor in a patient with AL amyloidosis who previously underwent heart transplantation due to amyloid heart involvement. Results and conclusion: This is the first report of spontaneous splenic rupture following stem cell mobilization with G-CSF and plerixafor in AL amyloidosis. The role of plerixafor has to be established. AL amyloidosis patients undergoing stem cell mobilization need careful monitoring of signs and symptoms of spontaneous splenic rupture.
MeSH term(s)	Adult ; Amyloidosis/pathology ; Amyloidosis/therapy ; Female ; Granulocyte Colony-Stimulating Factor/administration & dosage ; Granulocyte Colony-Stimulating Factor/adverse effects ; Hematopoietic Stem Cell Mobilization/adverse effects ; Heterocyclic Compounds/administration & dosage ; Heterocyclic Compounds/adverse effects ; Humans ; Rupture, Spontaneous ; Splenic Rupture/etiology ; Splenic Rupture/pathology
Chemical Substances	Heterocyclic Compounds ; Granulocyte Colony-Stimulating Factor (143011-72-7) ; plerixafor (S915P5499N)
Language	English
Publishing date	2015-09-28
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	2046795-3
ISSN	1878-1683 ; 1473-0502
ISSN (online)	1878-1683
ISSN	1473-0502
DOI	10.1016/j.transci.2015.09.001
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Article ; Online: The importance of getting evidence into practice.

Marson, Anthony G

Nature reviews. Neurology

2022 Volume 18, Issue 8, Page(s) 443–444

MeSH term(s)	Evidence-Based Medicine ; Humans
Language	English
Publishing date	2022-06-23
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2491514-2
ISSN	1759-4766 ; 1759-4758
ISSN (online)	1759-4766
ISSN	1759-4758
DOI	10.1038/s41582-022-00689-8
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Zs.A 6257: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Efficiency of immunoglobulin G replacement therapy in common variable immunodeficiency: correlations with clinical phenotype and polymorphism of the neonatal Fc receptor.

Gouilleux-Gruart, V / Chapel, H / Chevret, S / Lucas, M / Malphettes, M / Fieschi, C / Patel, S / Boutboul, D / Marson, M-N / Gérard, L / Lee, M / Watier, H / Oksenhendler, E

Clinical and experimental immunology

2013 Volume 171, Issue 2, Page(s) 186–194

Abstract: ... using intravenous (i.v.) or subcutaneous (s.c.) immunoglobulin (Ig)G. Interindividual variation of IgG ...

Abstract	Treatment of common variable immunodeficiency disorders (CVID) is based on replacement therapy using intravenous (i.v.) or subcutaneous (s.c.) immunoglobulin (Ig)G. Interindividual variation of IgG dose is common. A total of 380 CVID patients on stable IgG replacement from two prospective cohorts were analysed. An 'efficiency' index was defined as the ratio of serum IgG trough level minus IgG residual to the average weekly dose of IgG infusion. A reduced efficiency of IgG was associated independently with the i.v. route (P < 0·001) and with the presence of at least one CVID disease-related phenotype (lymphoproliferation, autoimmune cytopenia or enteropathy) (P < 0·001). High IgG efficiency was noted in patients homozygotes for the variable number tandem repeat (VNTR) 3/3 polymorphism of the neonatal Fc receptor gene [IgG Fc fragment receptor transporter alpha chain (FCGRT)] promoter, and this was particularly significant in patients treated with IVIG (P < 0.01). In a multivariate analysis, FCGRT VNTR 3/3 genotype (P = 0·008) and high serum albumin (P < 0·001) were associated independently with increased efficiency of i.v. Ig.
MeSH term(s)	Adult ; Biomarkers, Pharmacological ; Cohort Studies ; Common Variable Immunodeficiency/drug therapy ; Common Variable Immunodeficiency/immunology ; Female ; Histocompatibility Antigens Class I/genetics ; Humans ; Immunoglobulins, Intravenous/administration & dosage ; Immunoglobulins, Intravenous/adverse effects ; Injections, Subcutaneous ; Male ; Middle Aged ; Minisatellite Repeats/genetics ; Phenotype ; Polymorphism, Genetic ; Promoter Regions, Genetic/genetics ; Prospective Studies ; Receptors, Fc/genetics ; Transcriptional Activation/genetics ; Treatment Outcome
Chemical Substances	Biomarkers, Pharmacological ; Histocompatibility Antigens Class I ; Immunoglobulins, Intravenous ; Receptors, Fc ; Fc receptor, neonatal (TW3XAW0RCY)
Language	English
Publishing date	2013-01-03
Publishing country	England
Document type	Journal Article
ZDB-ID	218531-3
ISSN	1365-2249 ; 0009-9104 ; 0964-2536
ISSN (online)	1365-2249
ISSN	0009-9104 ; 0964-2536
DOI	10.1111/cei.12002
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Article ; Online: Neurology beyond big data - the ninth Congress of the EAN.

Kallweit, Ulf / Marson, Anthony G

Nature reviews. Neurology

2023 Volume 19, Issue 8, Page(s) 445–446

MeSH term(s)	Humans ; Big Data ; Neurology
Language	English
Publishing date	2023-06-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2491514-2
ISSN	1759-4766 ; 1759-4758
ISSN (online)	1759-4766
ISSN	1759-4758
DOI	10.1038/s41582-023-00837-8
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Zs.A 6257: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Morbidity and mortality risks associated with valproate withdrawal in young men and women with epilepsy.

Mbizvo, Gashirai K / Bucci, Tommaso / Lip, Gregory Y H / Marson, Anthony G

Brain : a journal of neurology

2024

Abstract: Valproate is the most effective treatment for idiopathic generalised epilepsy. Current guidance precludes its use in women of childbearing potential, unless other treatments are ineffective or not tolerated, because of high teratogenicity. This risk was ... ...

Abstract	Valproate is the most effective treatment for idiopathic generalised epilepsy. Current guidance precludes its use in women of childbearing potential, unless other treatments are ineffective or not tolerated, because of high teratogenicity. This risk was recently extended to men. New guidance will limit use both in men and women aged <55 years, resulting in withdrawal of valproate from men already taking it, as occurs for women. Whether there are risks of personal harm (including injury or death) associated with valproate withdrawal has not yet been quantified for men or women on valproate, meaning clinicians cannot reliably counsel either sex when discussing valproate withdrawal with them, despite that this concern may be at the forefront of patients' and clinicians' minds. We assessed whether there are any morbidity or mortality risks associated with valproate withdrawal in young men and women. We performed a retrospective cohort study of internationally derived electronic health data within the TriNetX Global Collaborative Network. Included were men and women aged 16-54 years with ≥1 epilepsy disease or symptom code between 01/12/2017-01/12/2018 and ≥2 valproate prescriptions over the preceding two years (01/01/2015-30/11/2017). 5-year propensity-matched risks of mortality and a range of morbidity outcomes were compared between those remaining on vs. withdrawn from valproate during the 01/12/2017-01/12/2018 recruitment period, regardless of whether switched to another antiseizure medication. Survival analysis was undertaken using Cox-proportional hazard models, generating hazard ratios (HRs) with 95% confidence intervals (CIs). 8,991 men and 5,243 women taking valproate were recruited. 28% of men and 36% of women were subsequently withdrawn from valproate. Valproate withdrawal was associated with significantly increased risks of emergency department attendance (HRs overall: 1.236 (CI 1.159-1.319), men: 1.181 (CI 1.083-1.288), women: 1.242 (CI 1.125-1.371)), hospital admission (HRs overall: 1.160 (CI 1.081-1.246), men: 1.132 (CI 1.027-1.249), women: 1.147 (CI 1.033-1.274)), falls (HRs overall: 1.179 (CI 1.041-1.336), men: 1.298 (CI 1.090-1.546)), injuries (HRs overall: 1.095 (CI 1.021-1.174), men: 1.129 (CI 1.029-1.239)), burns (HRs overall: 1.592 (CI 1.084-2.337)), and new-onset depression (HRs overall 1.323 (CI 1.119-1.565), women: 1.359 (CI 1.074-1.720)). The risk of these outcomes occurring was 1-7% higher in those withdrawn from valproate than in those remaining on valproate. Overall, valproate withdrawal was not associated with increased mortality. These results may help patients and clinicians have a more informed discussion about personal safety when considering valproate withdrawal.
Language	English
Publishing date	2024-04-24
Publishing country	England
Document type	Journal Article
ZDB-ID	80072-7
ISSN	1460-2156 ; 0006-8950
ISSN (online)	1460-2156
ISSN	0006-8950
DOI	10.1093/brain/awae128
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Article ; Online: Vagus nerve stimulation for focal seizures.

Panebianco, Mariangela / Rigby, Alexandra / Marson, Anthony G

The Cochrane database of systematic reviews

2022 Volume 7, Page(s) CD002896

MeSH term(s)	Adult ; Anticonvulsants/therapeutic use ; Child ; Cough ; Drug Resistant Epilepsy/drug therapy ; Drug Therapy, Combination ; Dyspnea/drug therapy ; Hoarseness/chemically induced ; Hoarseness/drug therapy ; Humans ; Pain/drug therapy ; Paresthesia/chemically induced ; Seizures/drug therapy ; Vagus Nerve Stimulation/adverse effects
Chemical Substances	Anticonvulsants
Language	English
Publishing date	2022-07-14
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review ; Research Support, Non-U.S. Gov't
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD002896.pub3
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Article ; Online: Lamotrigine add-on therapy for drug-resistant focal epilepsy.

Panebianco, Mariangela / Bresnahan, Rebecca / Marson, Anthony G

The Cochrane database of systematic reviews

2023 Volume 12, Page(s) CD001909

Abstract: Background: This is an updated version of a Cochrane Review last updated in 2020. Epilepsy is a common neurological disorder, affecting 0.5% to 1% of the population. In nearly 30% of cases, epilepsy is resistant to currently available drugs. ... ...

Abstract	Background: This is an updated version of a Cochrane Review last updated in 2020. Epilepsy is a common neurological disorder, affecting 0.5% to 1% of the population. In nearly 30% of cases, epilepsy is resistant to currently available drugs. Pharmacological treatment remains the first choice to control epilepsy. Lamotrigine is a second-generation antiseizure medication. When used as an add-on (in combination with other antiseizure medications), lamotrigine can reduce seizures, but with some adverse effects. Objectives: To evaluate the benefits and harms of add-on lamotrigine, compared with add-on placebo or no add-on treatment in people with drug-resistant focal epilepsy. Search methods: For this update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid) on 3 October 2022 with no language restrictions. CRS Web includes randomised and quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialised Registers of Cochrane Review Groups, including Epilepsy. Selection criteria: We included randomised controlled trials (RCTs) that investigated add-on lamotrigine versus add-on placebo or no add-on treatment in people of any age with drug-resistant focal epilepsy. We used data from the first period of eligible cross-over trials. Data collection and analysis: For this update, two review authors independently selected trials and extracted data. Our primary outcome was 50% or greater reduction in seizure frequency. Our secondary outcomes were treatment withdrawal, adverse effects, cognitive effects, and quality of life. Primary analyses were by intention-to-treat. We performed sensitivity best- and worse-case analyses to account for missing outcome data. We calculated pooled risk ratios (RRs) with 95% confidence intervals (95% Cls) for dichotomous outcomes. Main results: We identified no new studies for this update, so the results and conclusions of the review are unchanged. We included five parallel-group studies in adults or children, eight cross-over studies in adults or children, and one parallel study with a responder-enriched design in infants. In total, these 14 studies enroled 1806 eligible participants (38 infants, 199 children, 1569 adults). Baseline phases ranged from four to 12 weeks and treatment phases ranged from eight to 36 weeks. We rated 11 studies (1243 participants) at low overall risk of bias and three (697 participants) at unclear overall risk of bias due to lack of information on study design. Four studies (563 participants) reported effective blinding. Lamotrigine compared with placebo probably increases the likelihood of achieving 50% or greater reduction in seizure frequency (RR 1.80, 95% CI 1.45 to 2.23; 12 trials, 1322 participants (adults and children); moderate-certainty evidence). There is probably little or no difference in risk of treatment withdrawal for any reason among people treated with lamotrigine versus people treated with placebo (RR 1.11, 95% CI 0.91 to 1.37; 14 trials; 1806 participants; moderate-certainty evidence). Lamotrigine compared with placebo is probably associated with a greater risk of ataxia (RR 3.34, 99% Cl 2.01 to 5.55; 12 trials; 1525 participants; moderate-certainty evidence), dizziness (RR 1.76, 99% Cl 1.28 to 2.43; 13 trials; 1768 participants; moderate-certainty evidence), nausea (RR 1.81, 99% CI 1.22 to 2.68; 12 studies, 1486 participants; moderate-certainty evidence), and diplopia (RR 3.79, 99% Cl 2.15 to 6.68; 3 trials, 944 participants; moderate-certainty evidence). There is probably little or no difference in the risk of fatigue between lamotrigine and placebo (RR 0.82, 99% CI 0.55 to 1.22; 12 studies, 1552 participants; moderate-certainty evidence). Authors' conclusions: Lamotrigine as an add-on treatment for drug-resistant focal seizures is probably effective for reducing seizure frequency. Certain adverse effects (ataxia, dizziness, diplopia, and nausea) are probably more likely to occur with lamotrigine compared with placebo. There is probably little or no difference in the number of people who withdraw from treatment with lamotrigine versus placebo. The trials were of relatively short duration and provided no long-term evidence. In addition, some trials had few participants. Further trials are needed to assess the long-term effects of lamotrigine and to compare lamotrigine with other add-on drugs.
MeSH term(s)	Adult ; Child ; Humans ; Lamotrigine/therapeutic use ; Diplopia/chemically induced ; Diplopia/drug therapy ; Dizziness/chemically induced ; Drug Therapy, Combination ; Anticonvulsants/adverse effects ; Seizures/drug therapy ; Drug Resistant Epilepsy/drug therapy ; Ataxia/chemically induced ; Ataxia/drug therapy ; Drug-Related Side Effects and Adverse Reactions ; Nausea/chemically induced ; Epilepsies, Partial/drug therapy ; Epilepsies, Partial/chemically induced
Chemical Substances	Lamotrigine (U3H27498KS) ; Anticonvulsants
Language	English
Publishing date	2023-12-11
Publishing country	England
Document type	Systematic Review ; Journal Article ; Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD001909.pub4
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Article ; Online: Immunomodulatory interventions for focal epilepsy.

Panebianco, Mariangela / Walker, Lauren / Marson, Anthony G

The Cochrane database of systematic reviews

2023 Volume 10, Page(s) CD009945

Abstract: Background: This is an updated version of an original Cochrane Review published in 2013 (Walker 2013). Epilepsy is a common neurological disorder affecting 0.5% to 1% of the population. Pharmacological treatment remains the first choice to control ... ...

Abstract	Background: This is an updated version of an original Cochrane Review published in 2013 (Walker 2013). Epilepsy is a common neurological disorder affecting 0.5% to 1% of the population. Pharmacological treatment remains the first choice to control epilepsy. However, up to 30% of people do not respond to drug treatment, and therefore do not achieve seizure remission. Experimental and clinical evidence supports a role for inflammatory pathway activation in the pathogenesis of epilepsy which, if effectively targeted by immunomodulatory interventions, highlights a potentially novel therapeutic strategy. Objectives: To assess the efficacy and tolerability of immunomodulatory interventions on seizures, adverse effect profile, cognition, and quality of life, compared to placebo controls, when used as additional therapy for focal epilepsy in children and adults. Search methods: For the latest update, we searched the following databases on 11 November 2021: Cochrane Register of Studies (CRS Web) and Medline (Ovid) 1946 to 10 November 2021. CRS Web includes randomised or quasi-randomised, controlled trials from PubMed, EMBASE, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialized Registers of Cochrane Review Groups including Epilepsy. We placed no language restrictions. We reviewed the bibliographies of retrieved studies to search for additional reports of relevant studies. Selection criteria: Randomised placebo-controlled trials of add-on immunomodulatory drug interventions, in which an adequate method of concealment of randomisation was used. The studies were double-, single- or unblinded. Eligible participants were children (aged over 2 years) and adults with focal epilepsy. Data collection and analysis: We used standard methodological procedures expected by the Cochrane Collaboration. We assessed the following outcomes. 1. 50% or greater reduction in seizure frequency. 2. Seizure freedom. 3. Treatment withdrawal for any reason. 4. Quality of life. 5. Adverse effects: We used an intention-to-treat (ITT) population for all primary analyses, and we presented results as risk ratios (RRs) with 95% confidence intervals (95% Cl). Main results: We included three randomised, double-blind, placebo-controlled trials on a total of 172 participants. All trials included children and adults over two years of age with focal epilepsy. Treatment phases lasted six weeks and follow-up from six weeks to six months. One of the three included trials described an adequate method of concealment of randomisation, whilst the other two trials were rated as having an unclear risk of bias due to lack of reported information around study design. Effective blinding of studies was reported in all three trials. All analyses were by ITT. One trial was sponsored by the manufacturer of an immunomodulatory agent and therefore was at high risk of funding bias. Immunomodulatory interventions were significantly more effective than placebo in reducing seizure frequency (risk ratio (RR) 2.30, 95% confidence interval (CI) 1.15 to 4.60; 3 studies, 172 participants; moderate-certainty evidence). For treatment withdrawal, there was insufficient evidence to conclude that people were more likely to discontinue immunomodulatory intervention than placebo (RR 1.04, 95% CI 0.28 to 3.80; 3 studies, 172 participants; low-certainty evidence). The RR for adverse effects was 1.16 (95% CI 0.84 to 1.59; 1 study, 66 participants; low-certainty evidence). Certain adverse effects such as dizziness, headache, fatigue, and gastrointestinal disorders were more often associated with immunomodulatory interventions. There were little to no data on cognitive effects and quality of life. No important heterogeneity between studies was found for any of the outcomes. We judged the overall certainty of evidence (using the GRADE approach) as low to moderate due to potential attrition bias resulting from missing outcome data and imprecise results with wide confidence intervals. Authors' conclusions: Immunomodulatory interventions as add-on treatment for children and adults with focal epilepsy appear to be effective in reducing seizure frequency. It is not possible to draw any conclusions about the tolerability of these agents in children and adults with epilepsy. Further randomised controlled trials are needed.
MeSH term(s)	Adult ; Child ; Humans ; Aged ; Anticonvulsants/adverse effects ; Quality of Life ; Drug Resistant Epilepsy/drug therapy ; Drug Therapy, Combination ; Epilepsies, Partial/drug therapy ; Epilepsies, Partial/chemically induced ; Seizures/drug therapy ; Drug-Related Side Effects and Adverse Reactions ; Randomized Controlled Trials as Topic
Chemical Substances	Anticonvulsants
Language	English
Publishing date	2023-10-16
Publishing country	England
Document type	Systematic Review ; Journal Article ; Review ; Research Support, Non-U.S. Gov't
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD009945.pub3
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In stock of ZB MED Cologne/Königswinter

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In stock of ZB MED Cologne/Königswinter

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Inter-library loan at ZB MED

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Inter-library loan at ZB MED

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Order via subito

Inter-library loan at ZB MED