Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial

Kamm, Christian Philipp; El-Koussy, Marwan; Humpert, Sebastian Jörg; Findling, Oliver; Burren, Yuliya; Schwegler, Guido; Donati, Filippo; Müller, Andrea Martin; Slotboom, Johannes; Kappos, Ludwig; Naegelin, Yvonne; Mattle, Heinrich; Müller, Felix (2014). Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial. PLoS ONE, 9(1), e86663. Public Library of Science 10.1371/journal.pone.0086663

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BACKGROUND Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects. OBJECTIVES To report the 12-month extension of a phase II trial evaluating the efficacy, safety and tolerability of atorvastatin 40 mg/d added to interferon beta-1b (IFNB-1b) in relapsing-remitting multiple sclerosis (RRMS). METHODS In the randomized, multicenter, parallel-group, rater-blinded core study, 77 RRMS patients started IFNB-1b. At month three they were randomized 1∶1 to receive atorvastatin 40 mg/d or not in addition to IFNB-1b until month 15. In the subsequent extension study, patients continued with unchanged medication for another 12 months. Data at study end were compared to data at month three of the core study. RESULTS 27 of 72 patients that finished the core study entered the extension study. 45 patients were lost mainly due to a safety analysis during the core study including a recruitment stop for the extension study. The primary end point, the proportion of patients with new lesions on T2-weighted images was equal in both groups (odds ratio 1.926; 95% CI 0.265-14.0007; p = 0.51). All secondary endpoints including number of new lesions and total lesion volume on T2-weighted images, total number of Gd-enhancing lesions on T1-weighted images, volume of grey and white matter, EDSS, MSFC, relapse rate, number of relapse-free patients and neutralizing antibodies did not show significant differences either. The combination therapy was well tolerated. CONCLUSIONS Atorvastatin 40 mg/day in addition to IFNB-1b did not have any beneficial effects on RRMS compared to IFNB-1b monotherapy over a period of 24 months.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Unit Childrens Hospital > Forschungsgruppe Pränatale Medizin
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology
04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Institute of Diagnostic and Interventional Neuroradiology

UniBE Contributor:

Kamm, Christian Philipp; El-Koussy, Marwan; Findling, Oliver; Burren, Yuliya; Donati, Filippo; Müller, Andrea Martin; Slotboom, Johannes and Mattle, Heinrich

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1932-6203

Publisher:

Public Library of Science

Language:

English

Submitter:

Martin Zbinden

Date Deposited:

04 Jun 2014 14:22

Last Modified:

11 Dec 2014 08:11

Publisher DOI:

10.1371/journal.pone.0086663

PubMed ID:

24497963

BORIS DOI:

10.7892/boris.48071

URI:

https://boris.unibe.ch/id/eprint/48071

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