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

Togha, Mansoureh; Karvigh, Sanaz Ahmadi; Nabavi, Seyed Massood; Moghadam, Nahid Beladi; Harirchian, Mohammad Hossein; Sahraian, Mohammad Ali; Enzevaei, Anahita; Nourian, Alireza; Ghanaati, Hossein; Firouznia, Kavous; Jannati, Ali; Shekiba, Majid

doi:10.1177/1352458510369147

Cited by 69 publications

(41 citation statements)

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“…Exacerbations were verified by an evaluating MS physician or trained registered nurse using the same definition implemented in recent DMT trials. 16 Participants were also evaluated clinically at 16-week intervals to document their EDSS and adverse events. Patients with confirmed exacerbations were referred to their physicians for treatment.…”

Section: Assessment Masking All Clinical Evaluators and Techniciansmentioning

confidence: 99%

“…The lost to follow-up rate of 22% in SMT-MS is comparable to many other trials of behavioral interventions, 29 while the loss of 10% of participants in the wait list control condition is consistent with rates seen in pharmaceutical trials in MS trials more generally. 16,30 There was no evidence that dropout was related to demographic or diseaserelated variables and our statistical analyses attempted to control for the lost to follow-up using imputation. However, it is possible that there were other unmeasured variables that that could have introduced bias.…”

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confidence: 99%

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A randomized trial of stress management for the prevention of new brain lesions in MS

et al. 2012

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Objectives: This trial examined the efficacy of a stress management program in reducing neuroimaging markers of multiple sclerosis (MS) disease activity. Methods:A total of 121 patients with relapsing forms of MS were randomized to receive stress management therapy for MS (SMT-MS) or a wait-list control condition. SMT-MS provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up. The primary outcome was the cumulative number of new gadolinium-enhancing (Gdϩ) brain lesions on MRI at weeks 8, 16, and 24. Secondary outcomes included new or enlarging T2 MRI lesions, brain volume change, clinical exacerbation, and stress.Results: SMT-MS resulted in a reduction in cumulative Gdϩ lesions (p ϭ 0.04) and greater numbers of participants remained free of Gdϩ lesions during the treatment (76.8% vs 54.7%, p ϭ 0.02), compared to participants receiving the control treatment. SMT-MS also resulted in significantly reduced numbers of cumulative new T2 lesions (p ϭ 0.005) and a greater number of participants remaining free of new T2 lesions (69.5% vs 42.7%, p ϭ 0.006). These effects were no longer detectable during the 24-week post-treatment follow-up period. Conclusions:This trial indicates that SMT-MS may be useful in reducing the development of new MRI brain lesions while patients are in treatment. Classification of evidence:This study provides Class I evidence that SMT-MS, a manualized stress management therapy program, reduced the number of Gdϩ lesions in patients with MS during a 24-week treatment period. This benefit was not sustained beyond 24 weeks, and there were no clinical benefits.Trial registration: ClinicalTrials.gov, number NCT00147446. Neurology ® 2012;79:412-419 GLOSSARY BIPS ϭ Brief Inventory of Perceived Stress; DMT ϭ disease-modifying therapy; EDSS ϭ Expanded Disability Status Scale; Gd؉ ϭ gadolinium-enhancing; ITT ϭ intent-to-treat; LES ϭ Life Events Scale; MS ϭ multiple sclerosis; NNT ϭ number needed to treat; RCT ϭ randomized controlled clinical trial; SMT-MS ϭ stress management therapy for multiple sclerosis; UCSF ϭ University of California San Francisco.Accumulating evidence suggests an association between stress and disease activity in multiple sclerosis (MS).1 Stressful life events have also been shown to precede new gadolinium-enhancing (Gdϩ) MRI brain lesions, a more objective measure of disease activity, by approximately 4 -8 weeks.2 Several studies have indicated that more adaptive coping moderates the effect of stress on the development of new Gdϩ lesions 3 and is associated with fewer exacerbations. 4 Cognitive behavioral stress management therapies (SMTs) teach coping skills that are aimed at enhancing a patient's ability to prevent stressful events from occurring and improving the capacity to manage their responses to those stressful events that do arise.The primary aim of this multicenter randomized controlled clinical trial (RCT) was to examine the efficacy of a well-validated SMT for MS (SMT-MS) 5 in reducing the occurrence of new Gdϩ les...

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Section: Assessment Masking All Clinical Evaluators and Techniciansmentioning

confidence: 99%

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confidence: 99%

A randomized trial of stress management for the prevention of new brain lesions in MS

et al. 2012

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“…4,5 Two meta-analyses of statins (atorvastatin and simvastatin) that examined the same trials found that there is no benefit of statins in regard to MS relapse rates, disease progression, or change in disability scores.…”

Section: Resultsmentioning

confidence: 99%

“…The authors concluded that the addition of simvastatin 40 mg daily to interferon therapy may reduce the relapse rate (moderate effect size, r = 0.29). 4 In a double-blind, placebo-controlled multicenter trial, 307 treatment-naïve patients with relapsingremitting MS received intramuscular interferon beta-1a (30 mcg weekly) for 3 months prior to randomization to concurrent therapy with simvastatin or placebo for at least 12 months and up to 36 months. Simvastatin was dosed as 40 mg daily for one month then increased to 80 mg daily.…”

Section: Controlled Trialsmentioning

confidence: 99%

Simvastatin: Multiple Sclerosis

Generali

Cada²

2015

Hosp Pharm

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This Hospital Pharmacy feature is extracted from Off-Label Drug Facts, a publication available from Wolters Kluwer Health. Off-Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by the US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published studies on off-label uses and determine if a specific use is rational in a patient care scenario. References direct the reader to the full literature for more comprehensive information before patient care decisions are made. Direct questions or comments regarding Off-Label Drug Uses to jgeneral@ku.edu.

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“…In an MRIbased study in patients with RR-MS, treatment with atorva statin, alone or in combination with IFN-β, led to a substantial reduction in the number and volume of CEL [139]. Moreover, a clinical study in RR-MS suggested that adding statins to IFN-β may reduce the relapse rate compared with IFN-β alone [140]. However, it has been shown that statins impair remyelination in vitro and in vivo [141].…”

Section: Promising Therapeutic Concepts With Putative Neuroprotectivementioning

confidence: 99%

Neurodegeneration in multiple sclerosis: novel treatment strategies

Luessi

Siffrin

Zipp³

2012

Expert Review of Neurotherapeutics

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In recent years it has become clear that the neuronal compartment already plays an important role early in the pathology of multiple sclerosis (MS). Neuronal injury in the course of chronic neuroinflammation is a key factor in determining long-term disability in patients. Viewing MS as both inflammatory and neurodegenerative has major implications for therapy, with CNS protection and repair needed in addition to controlling inflammation. Here, the authors' review recently elucidated molecular insights into inflammatory neuronal/axonal pathology in MS and discuss the resulting options regarding neuroprotective and regenerative treatment strategies. Neurodegeneration in multiple sclerosis: novel treatment strategiesExpert Rev. Neurother. 12(9), 1061-1077 (2012) Keywords: multiple sclerosis • neurodegeneration • neuronal injury • neuroprotection • treatment Medscape: Continuing Medical Education OnlineThis activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Medscape, LLC and Expert Reviews Ltd. Medscape, LLC is accredited by the ACCME to provide continuing medical education for physicians.Medscape, LLC designates this Journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.All other clinicians completing this activity will be issued a certificate of participation. To participate in this journal CME activity: (1) review the learning objectives and author disclosures; (2) study the education content; (3) take the post-test with a 70% minimum passing score and complete the evaluation at www.medscape.org/journal/expertneurothera; (4) view/print certificate. Learning objectivesUpon completion of this activity, participants will be able to:• Describe recent insights into inflammatory neuronal injury in multiple sclerosis, based on a review • Describe methods of quantification of neuronal injury in patients with multiple sclerosis, based on a review • Describe applications of these findings to treatment for patients with multiple sclerosis, based on a review

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

Cited by 69 publications

References 23 publications

A randomized trial of stress management for the prevention of new brain lesions in MS

A randomized trial of stress management for the prevention of new brain lesions in MS

Simvastatin: Multiple Sclerosis

Neurodegeneration in multiple sclerosis: novel treatment strategies

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