scholarly journals A non‐randomized clinical trial to evaluate the effect of fingolimod on expanded disability status scale score and number of relapses in relapsing‐remitting multiple sclerosis patients

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Mehrdokht Mazdeh ◽  
Shahriar Kargar Monhaser ◽  
Mohammad Taheri ◽  
Soudeh Ghafouri‐Fard
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Scale Score ◽  
Expanded Disability Status Scale ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Simvastatin treatment in patients with relapsing-remitting multiple sclerosis receiving interferon beta 1a: a double-blind randomized controlled trial

2010 ◽  
Vol 16 (7) ◽  
pp. 848-854 ◽  
Author(s):  
Mansoureh Togha ◽  
Sanaz Ahmadi Karvigh ◽  
Masoud Nabavi ◽  
Nahid Beladi Moghadam ◽  
Mohammad Hossein Harirchian ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Placebo Group ◽  
Scale Score ◽  
Expanded Disability Status Scale ◽  
T2 Lesions ◽  
Simvastatin Group ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Objectives: This study was conducted to evaluate the effect of simvastatin (40 mg/day) as an adjuvant therapy to interferon beta (IFNb 1a, 30 µg once weekly) in relapsing—remitting multiple sclerosis patients, compared with placebo. Methods: We enrolled 85 patients with relapsing—remitting multiple sclerosis (71% female) who were already receiving IFNb 1a (Avonex), with Expanded Disability Status Scale score of less than 5.0. The patients were assigned (in random and double-blinded fashion) into the two groups of simvastatin and placebo. All patients continued to receive their current IFNb treatment. The outcome measures were total relapse rate, Expanded Disability Status Scale score, and the number of gadolinium-enhanced (Gd+) and new T2 lesions in magnetic resonance imaging after a 1-year follow-up. We used Mann—Whitney and one-way multivariate analysis of variances to analyze the data. Results: Four patients in the placebo and two in the simvastatin group prematurely withdrew from the study due to experiencing two attacks. The total attack number in the simvastatin group was significantly lower than placebo group (moderate effect size r = 0.29) ( p = 0.01). The final Expanded Disability Status Scale scores were lower in the simvastatin group (1.01 ± 1.40, mean ± SD) than in the placebo group (1.73 ± 1.49, mean ± SD), but this difference was not significant after controlling the baseline Expanded Disability Status Scale score ( p = 0.07). In the simvastatin group, the mean ± SD of gadolinium-enhanced and new T2 lesions were 0.66 ± 1.18 and 3.39 ± 3.55, respectively, (compared with 0.74 ± 1.21 and 3.39 ± 3.55 in the placebo group). Although there was a decreasing trend in lesions on magnetic resonance imaging, this difference was not statistically significant ( p = 0.62). The combination therapy was safe and well tolerated, and no serious adverse effect was noted. Conclusion: Our study supports the safety and efficacy of simvastatin as an add-on therapy to INFb 1a in patients with relapsing—remitting multiple sclerosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT00668343. This interventional study provides Class I evidence stating that adding simvastatin 40 mg/day to IFNb 1a 30 µg a week in patients with relapsing—remitting multiple sclerosis may reduce the relapse rate (moderate effect size r = 0.29) ( p = 0.01) compared with treatment with IFNb 1a alone.

No evidence for an effect on brain atrophy rate of atorvastatin add-on to interferon β1b therapy in relapsing–remitting multiple sclerosis (the ARIANNA study)

2016 ◽  
Vol 22 (9) ◽  
pp. 1163-1173 ◽  
Author(s):  
Roberta Lanzillo ◽  
Mario Quarantelli ◽  
Carlo Pozzilli ◽  
Maria Trojano ◽  
Maria Pia Amato ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Brain Atrophy ◽  
Composite Score ◽  
Expanded Disability Status Scale ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background: A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis. Objectives: The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing–remitting multiple sclerosis. Methods: This randomised, placebo-controlled study compared atorvastatin 40 mg or placebo add-on therapy to interferon β1b for 24 months. Brain magnetic resonance imaging, multiple sclerosis functional composite score, Rao neuropsychological battery and expanded disability status scale were evaluated over 24 months. Results: A total of 154 patients were randomly assigned, 75 in the atorvastatin and 79 in the placebo arms, with a comparable drop-out rate (overall 23.4%). Brain atrophy over 2 years was not different in the two arms (−0.38% and −0.32% for the atorvastatin and placebo groups, respectively). Relapse rate, expanded disability status scale, multiple sclerosis functional composite score or cognitive changes were not different in the two arms. Patients withdrawing from the study had a higher number of relapses in the previous 2 years ( P=0.04) and a greater probability of relapsing within 12 months. Conclusions: Our results suggest that the combination of atorvastatin and interferon β1b is not justified in early relapsing–remitting multiple sclerosis and adds to the body of evidence indicating an absence of significant radiological and clinical benefit of statins in relapsing–remitting multiple sclerosis.

scholarly journals A voxel-based morphometry study of disease severity correlates in relapsing— remitting multiple sclerosis

2009 ◽  
Vol 16 (1) ◽  
pp. 45-54 ◽  
Author(s):  
A. Prinster ◽  
M. Quarantelli ◽  
R. Lanzillo ◽  
G. Orefice ◽  
G. Vacca ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
White Matter ◽  
Grey Matter ◽  
Disease Duration ◽  
Expanded Disability Status Scale ◽  
Lesion Load ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Previous studies have shown a preferential loss of grey matter in fronto-temporal regions in patients with multiple sclerosis. Studies of correlates of disease severity are more controversial, because some studies have suggested an association between sensorimotor cortex atrophy and Expanded Disability Status Scale score, while others did not find such a correlation. The objective of this study was to assess the correlation of regional loss of grey matter and white matter with indexes of clinical and radiological severity in relapsing—remitting multiple sclerosis, including the Expanded Disability Status Scale and lesion load. Correlations between Expanded Disability Status Scale, lesion load and disease duration were assessed in 128 patients with relapsing—remitting multiple sclerosis (Expanded Disability Status Scale range 1.0—6.0) using optimized voxel-based morphometry. Bilateral loss of grey matter in sensorimotor cortices was correlated with Expanded Disability Status Scale, and tissue loss also involved adjacent white matter, extending along pyramidal tracts to the brainstem. Increasing lesion load was correlated with loss of deep grey matter and white matter. No specific region of grey matter or white matter showed a significant correlation with disease duration. These findings support the hypothesis that motor neuron involvement plays a major role in the progression of physical disability. Lesion load accrual affects mainly highly interconnected subcortical structures, while disease duration has a less significant impact on brain atrophy, probably owing to the inter-subject heterogeneity of the clinical course of the disease.

scholarly journals Effects of photobiomodulation on interleukin-10 and nitrites in individuals with relapsing-remitting multiple sclerosis – Randomized clinical trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (4) ◽  
pp. e0230551
Author(s):  
Tamiris Silva ◽  
Yara Dadalti Fragoso ◽  
Maria Fernanda Setúbal Destro Rodrigues ◽  
Andréa Oliver Gomes ◽  
Fernanda Cordeiro da Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Interleukin 10 ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis
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