Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial

Sørensen, Per Soelberg; Lycke, Jan; Erälinna, Juha-Pekka; Edland, Astrid; Wu, Xingchen; Frederiksen, Jette Lautrup; Oturai, Annette Bang; Malmeström, Clas; Stenager, Egon; Sellebjerg, Finn; Søndergaard, Helle Bach

doi:10.1016/s1474-4422(11)70144-2

Cited by 111 publications

(88 citation statements)

References 39 publications

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“…Still, only 1 patient was under treatment with a statin, excluding the possible and meaningful interference of this kind of drugs in our results. Some studies of statin treatment in MS were performed, but they originated mixed results [28][29][30][31][32][33]. In a study of 30 MS patients, the treatment with simvastatin resulted in a significant reduction in the number and volume of contrastenhancing lesions, on serial monthly MRI [28].…”

Section: Discussionmentioning

confidence: 99%

“…The STAyCIS study tried to assess the effect of statin treatment in slowing the conversion of clinical isolated syndromes to clinically definite MS, but it did not meet its primary endpoint (development of 3 or more new T2 lesions or 1 clinical relapse within 12 months) [32]. The SIM-COMBIN trial indicated that statin treatment did not provide benefit in MS patients on interferon beta [33]. According to our knowledge, this is the first study showing a strong correlation between EDSS score and Ox-LDL and LDL, suggesting a negative impact of LDL-c, and particularly of Ox-LDL, on EDSS.…”

Section: Discussionmentioning

confidence: 99%

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New Markers of Early Cardiovascular Risk in Multiple Sclerosis Patients: Oxidized-LDL Correlates with Clinical Staging

et al. 2013

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Abstract. OBJECTIVES:This study aimed to characterize a population of multiple sclerosis (MS) patients in terms of traditional and new cardiovascular risk factors and assess their putative correlation with clinical disease activity (evaluated by the Expanded Disability Status Scale [EDSS] 00 (28.25-40.25) years and scoring a median of 2.00 (1.50-3.13) in EDSS. Comparing with controls, the most relevant differences encountered were: increased serum triglycerides (P < 0.001), Ox-LDL (P < 0.001) as well as Ox-LDL/LDL ratio and reduced small HDL (P = 0.040), accompanied by a trend to increased VEGF concentration. LDL content, especially Ox-LDL, showed positive and significant correlation with EDSS (r = 0.458; P = 0.011) and VEGF (r = 0.453; P = 0.014). CONCLUSIONS: MS patients presented a profile of early CV risk, being Ox-LDL contents a putative good marker and having correlation with the clinical activity of the disease.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

New Markers of Early Cardiovascular Risk in Multiple Sclerosis Patients: Oxidized-LDL Correlates with Clinical Staging

et al. 2013

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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%

“…There were no significant differences between the groups for the rates of infections, creatine phosphokinase, psychiatric disorders, or musculoskeletal complaints. 4,5 …”

Section: Safetymentioning

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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“…Among the two studies comparing simvastatin to placebo, the findings were mixed with only one suggesting reduced relapse rate, and neither showing differences between groups in T2 lesions, contrast-enhancing lesions, time to first relapse, or EDSS change. 39,40 The four studies comparing atorvastatin with placebo also had mixed findings with two suggesting a reduction in disease activity, one…”

Section: Dyslipidemiamentioning

confidence: 99%

A Review of Vascular Disease Risk Factors and Multiple Sclerosis

Kannan¹,

Yadav²

2017

US Neurology

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Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system and the most common non-traumatic cause of disability in young adults. Recent research shows that vascular disease risk factors (VDRFs) such as obesity, smoking, hyperlipidemia, hypertension, type II diabetes mellitus, and metabolic syndrome, can influence MS on its onset, disease activity, progression, and resultant disability. This review evaluates the current knowledge on the role of VDRFs on outcomes among people with MS (PwMS) and shows that while VDRF prevalence may or may not be higher among PwMS compared with the general population, its presence can influence MS in myriad ways. Management of VDRFs through early detection and treatment may be a promising approach to improving outcomes in PwMS. KeywordsMultiple sclerosis, smoking, obesity, dyslipidemia, hypertension, type II diabetes, metabolic syndrome Compliance with Ethics:This study involves a review of the literature and did not involve any studies with human or animal subjects performed by any of the authors.Authorship: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any noncommercial use, distribution, adaptation, and reproduction provided the original author(s) and source are given appropriate credit. Multiple sclerosis (MS) is the most common inflammatory demyelinating disease of the central nervous system and the most common non-traumatic cause of disability in young adults. MS affects nearly 400,000 people in the US and 2.5 million people worldwide. While the precise etiology of MS is unknown, it is suspected that the disease causation is multifactorial, in which exposure to environmental factors triggers an autoimmune response among genetically susceptible individuals.1 Recent research suggests an important plausible role of vascular disease risk factors (VDRFs) such as smoking, obesity, hyperlipidemia, hypertension, diabetes, and metabolic syndrome on MS pathogenesis. It is estimated that nearly 50% of people with MS (PwMS) have at least one VDRF at the time of their MS diagnosis, and are more likely than healthy controls to have more than one VDRF.2,3 The presence of VDRFs among PwMS appears to be associated not only with ongoing radiographic disease activity and progression on magnetic resonance imaging (MRI), but also with increased risk of clinical disability progression.3-5 The purpose of this paper is to examine the current literature on the relationship between these potentially modifiable factors that affect MS onset, activity, progression, and disability, and identify potential targets for improving clinical outcome among PwMS. SmokingThe association between smoking and MS susceptibility has been investigated extensively over...

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Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial

Cited by 111 publications

References 39 publications

New Markers of Early Cardiovascular Risk in Multiple Sclerosis Patients: Oxidized-LDL Correlates with Clinical Staging

New Markers of Early Cardiovascular Risk in Multiple Sclerosis Patients: Oxidized-LDL Correlates with Clinical Staging

Simvastatin: Multiple Sclerosis

A Review of Vascular Disease Risk Factors and Multiple Sclerosis

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