SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS) - rationale, design and methodology

Trials

Volumn 10, Issue , 2009, Pages

  Kamm, Christian P ^a   Mattle, Heinrich P ^a  

^a UNIVERSITY OF BERN   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; INTERFERON BETA SERINE; METHYLPREDNISOLONE; PREDNISOLONE; BETA INTERFERON; HEPTANOIC ACID DERIVATIVE; HYPOCHOLESTEROLEMIC AGENT; IMMUNOLOGICAL ADJUVANT; INTERFERON BETA-1B; PYRROLE DERIVATIVE;

ADD ON THERAPY; ADULT; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE SCLEROSIS; PARALLEL DESIGN; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SWITZERLAND; DRUG COMBINATION; RECURRENT DISEASE;

ADJUVANTS, IMMUNOLOGIC; ANTICHOLESTEREMIC AGENTS; DRUG THERAPY, COMBINATION; HEPTANOIC ACIDS; HUMANS; INTERFERON-BETA; MULTIPLE SCLEROSIS, RELAPSING-REMITTING; PYRROLES; RECURRENCE; SWITZERLAND;

EID: 74049148874     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-115     Document Type: Article

References (19)

1. Lassmann H, Brück W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol 2007, 17:210-218. 10.1111/j.1750-3639.2007.00064.x, 17388952.
2. IFNB Multiple Sclerosis Study Group Interferon beta-lb is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 1993, 43:655-661.
3. Kobashigawa JA, Katznelson S, Laks H, Johnson JA, Yeatman L, Wang XM, Chia D, Terasaki PI, Sabad A, Cogert GA, Trosian K, Hamilton MA, Moriguchi JD, Kawata N, Hage A, Drinkwater DC, Stevenson LW. Effect of Pravastatin on Outcomes after Cardiac Transplantation. NEJM 1995, 333:621-627. 10.1056/NEJM199509073331003, 7637722.
4. Stanislaus R, Pahan K, Singh AK, Singh I. Amelioration of experimental allergic encephalomyelitis in Lewis rats by lovastatin. Neurosci Lett 1999, 269:71-74. 10.1016/S0304-3940(99)00414-0, 10430507.
5. Stanislaus R, Singh AK, Singh I. Lovastatin treatment decreases mononuclear cell infiltration into the CNS of Lewis rats with experimental allergic encephalomyelitis. J Neurosci Res 2001, 66:155-162. 10.1002/jnr.1207, 11592110.
6. Youssef S, Stuve O, Patarroyo JC, Ruiz PJ, Radosevich JL, Hur EM, Bravo M, Mitchell DJ, Sobel RA, Steinman L, Zamvil SS. The HMG-CoA reductase inhibitor, atorvastatin, promotes a Th2 bias and reverses paralysis in central nervous system autoimmune disease. Nature 2002, 420:78-84. 10.1038/nature01158, 12422218.
7. Vollmer T, Key L, Durkalski V, Tyor W, Corboy J, Markovic-Plese S, Preiningerova J, Rizzo M, Singh I. Oral simvastatin treatment in relapsing-remitting multiple sclerosis. Lancet 2004, 363:1607-1608. 10.1016/S0140-6736(04)16205-3, 15145635.
8. Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dörr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS ONE 2008, 3:e1928. 10.1371/journal.pone.0001928, 2276246, 18398457.
9. Orefice G, Quarantelli M, Salvatore P. Interferon beta-1a and atorvastatin combination therapy: 12-month results from an open-label, randomized, clinical study. Neurology 2008, 70(Suppl 1). p02.139.
10. Marcivic-Plese S, Singh AK, Singh I. Therpeutic potential of statins in multiple sclerosis: immune modulation, neuropotection and neurorepair. Future Neurology 2008, 3:153-167.
11. Birnbaum G, Cree B, Altafullah I, Zinser M, Reder AT. Combining beta interferon and atorvastatin may increase disease activity in multiple sclerosis. Neurology 2008, 71:1390-1395. 10.1212/01.wnl.0000319698.40024.1c, 18525027.
12. Klopfleisch S, Merkler D, Schmitz M, Klöppner S, Schedensack M, Jeserich G, Althaus HH, Brück W. Negative impact of statins on oligodendrocytes and myelin formation in vitro and in vivo. J Neurosci 2008, 28:13609-13614. 10.1523/JNEUROSCI.2765-08.2008, 19074034.
13. Miron VE, Zehntner SP, Kuhlmann T, Ludwin SK, Owens T, Kennedy TE, Bedell BJ, Antel JP. Statin therapy inhibits remyelination in the central nervous system. Am J Pathol 2009, 174:1880-1890. 10.2353/ajpath.2009.080947, 2671276, 19349355.
14. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983, 33:1444-1452.
15. Fischer JS, Rudick RA, Cutter GR, Reingold SC. The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler 1999, 5:244-50.
16. Ashburner J, Friston KJ. Unified segmentation. Neuroimage 2005, 26:839-851. 10.1016/j.neuroimage.2005.02.018, 15955494.
17. Lee H, Prohovnik I. Cross-validation of brain segmentation by SPM5 and SIENAX. Psychiatry Res 2008, 164:172-177. 10.1016/j.pscychresns.2007.12.008, 2778005, 18930381.
18. WHO Expert Committee on Biological Standardization Thirty-fifth report. World Health Organ Tech Rep Ser 1985, 725:1-140.
19. Bertolotto A, Malucchi S, Sala A, Orefice G, Carrieri PB, Capobianco M, Milano E, Melis F, Giordana MT. Differential effects of three interferon betas on neutralising antibodies in patients with multiple sclerosis: a follow up study in an independent laboratory. J Neurol Neurosurg Psychiatry 2002, 73:148-53. 10.1136/jnnp.73.2.148, 1737963, 12122172.