Results of a Randomized Open Multicenter Comparative Study of the Tolerability and Safety of Gilenya (fingolimod) in Patients with Remitting Multiple Sclerosis (the GIMN study)

Popova, E. V.; Бойко, А. Н.; Boiko, Olha

doi:10.1007/s11055-016-0370-2

Cited by 2 publications

(3 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A meta-analysis including the five studies which provided the necessary information also found that depression improved ( Fig. 4A, SMD [95%CI]; 1.18 [0.17, 2.19]) (Bayas et al, 2016;Hersh et al, 2017;Hunter et al, 2016;Moreau et al, 2017;Popova et al, 2017). High heterogeneity existed between estimates (I 2 99%; p = 0.0001).…”

Section: Fingolimodmentioning

confidence: 84%

“…The RD (95%CI) ranged from −3.5% (−6.8%, −0.3%) to 0.7% (−7.3%, 8.7%) ( Fig. 3) (Calabresi et al, 2014;Cohen et al, 2010;Kappos et al, 2006Kappos et al, , 2010Lublin et al, 2016;Novartis, 2015;Popova et al, 2017). Two RCTs reported anxiety (Calabresi et al, 2014;Kappos et al, 2006).…”

Section: Fingolimodmentioning

confidence: 98%

“…Eight publications, representing six unique studies (2 observational, 4 RCTs) examined changes in depression symptoms following fingolimod treatment using various tools (Achiron et al, 2017;Bayas et al, 2016;Calkwood et al, 2014;Fox et al, 2014;Hersh et al, 2017;Hunter et al, 2016;Montalban et al, 2011;Moreau et al, 2017;Popova et al, 2017). In all studies, depression symptoms improved following fingolimod treatment.…”

Section: Fingolimodmentioning

confidence: 99%

See 2 more Smart Citations

Adverse psychiatric effects of disease-modifying therapies in multiple Sclerosis: A systematic review

Gasim

Bernstein

Graff

et al. 2018

Multiple Sclerosis and Related Disorders

View full text Add to dashboard Cite

show abstract

Section: Fingolimodmentioning

confidence: 84%

Section: Fingolimodmentioning

confidence: 98%

Section: Fingolimodmentioning

confidence: 99%

See 1 more Smart Citation

Adverse psychiatric effects of disease-modifying therapies in multiple Sclerosis: A systematic review

Gasim

Bernstein

Graff

et al. 2018

Multiple Sclerosis and Related Disorders

View full text Add to dashboard Cite

show abstract

Risk for Cardiovascular Adverse Events Associated With Sphingosine-1-Phosphate Receptor Modulators in Patients With Multiple Sclerosis: Insights From a Pooled Analysis of 15 Randomised Controlled Trials

Zhao

et al. 2021

Front. Immunol.

View full text Add to dashboard Cite

BackgroundAll agents engaging sphongosine-1-phospate receptors (S1PRs) will have some cardiovascular effect. This study aimed to elucidate the risk of cardiovascular adverse events (AEs) in patients with multiple sclerosis (MS) treated with S1PR modulators (S1PRMs).MethodsWe systematically searched the PubMed, EMBASE, and Cochrane Library databases for randomised controlled trials (RCTs) published through January 5, 2021. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated using the random-effects model. Sensitivity analyses and meta-regression were performed.ResultsSeventeen RCTs (12 for fingolimod; 3 for ozanimod; 2 for siponimod) involving 13,295 patients were included. Compared with the control treatment, S1PRMs significantly increased the risk of cardiovascular AEs (RR, 2.21; 95% CI, 1.58–3.10; I2, 75.6%). Notably, the high-risk cardiovascular AEs associated with S1PRMs were primarily bradyarrhythmia (RR, 2.92; 95% CI, 1.91–4.46; I2, 30.8%) and hypertension (RR, 2.00; 95% CI, 1.49–2.67; I2, 56.5%). Subgroup analysis results were consistent with the primary outcomes except that ozanimod was associated with a higher risk of hypertension only (RR, 1.76; 95% CI, 1.10–2.82; I2, 0.0%), while siponimod was associated with a higher risk of bradyarrhythmia only (RR, 2.75; 95% CI, 1.75–4.31; I2, 0.0%). No significant inter-subgroup differences were observed (Pinteraction > 0.05).ConclusionsS1PRM use increased the risk of cardiovascular AEs by 1.21 times in patients with MS, and increased risks for bradyarrhythmia and hypertension were at 2.92- and 2.00-fold, respectively. These findings can help clinicians assess the risk of cardiovascular AEs in patients treated with S1PRMs.Systematic Review RegistrationThe PROSPERO ID is CRD42020183215.

show abstract

Results of a Randomized Open Multicenter Comparative Study of the Tolerability and Safety of Gilenya (fingolimod) in Patients with Remitting Multiple Sclerosis (the GIMN study)

Cited by 2 publications

References 9 publications

Adverse psychiatric effects of disease-modifying therapies in multiple Sclerosis: A systematic review

Adverse psychiatric effects of disease-modifying therapies in multiple Sclerosis: A systematic review

Risk for Cardiovascular Adverse Events Associated With Sphingosine-1-Phosphate Receptor Modulators in Patients With Multiple Sclerosis: Insights From a Pooled Analysis of 15 Randomised Controlled Trials

Contact Info

Product

Resources

About