Atorvastatin added to interferon beta for relapsing multiple sclerosis: 12-month treatment extension of the randomized multicenter SWABIMS trial.
BACKGROUND
Statins have anti-inflammatory and immunomodulatory properties in addition to lipid-lowering effects.


OBJECTIVE
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.


BACKGROUND
ClinicalTrials.gov NCT01111656.
Department of Neurology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Christian P
CP
Kamm
Department of Diagnostic and Interventional Neuroradiology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Marwan
M
El-Koussy
Department of Neurology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Sebastian
S
Humpert
Department of Neurology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Oliver
O
Findling
Department of Diagnostic and Interventional Neuroradiology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Yuliya
Y
Burren
Department of Neurology, Cantonal Hospital Aarau, Aarau, Switzerland.
Guido
G
Schwegler
Department of Neurology, Spitalzentrum Biel, Biel, Switzerland.
Filippo
F
Donati
Department of Neurology, Cantonal Hospital Lucerne, Luzern, Switzerland.
Martin
M
Müller
Department of Neurology, Cantonal Hospital, Muensterlingen, Muensterlingen, Switzerland.
Felix
F
Müller
Department of Diagnostic and Interventional Neuroradiology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Johannes
J
Slotboom
Department of Neurology, University Hospital, University of Basel, Basel, Switzerland.
Ludwig
L
Kappos
Department of Neurology, University Hospital, University of Basel, Basel, Switzerland.
Yvonne
Y
Naegelin
Department of Neurology, Inselspital, University Hospital Bern and University of Bern, Bern, Switzerland.
Heinrich P
HP
Mattle
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000328:Adult; D000069059:Atorvastatin; D004359:Drug Therapy, Combination; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
D000276:Adjuvants, Immunologic; D006538:Heptanoic Acids; D011758:Pyrroles; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000069059:Atorvastatin