Sökning: onr:"swepub:oai:gup.ub.gu.se/144676" >
Simvastatin as add-...
Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial.
-
Sorensen, Per Soelberg (författare)
-
- Lycke, Jan, 1956 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap och rehabilitering,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation
-
Erälinna, Juha-Pekka (författare)
-
visa fler...
-
Edland, Astrid (författare)
-
Wu, Xingchen (författare)
-
Frederiksen, Jette Lautrup (författare)
-
Oturai, Annette (författare)
-
- Malmeström, Clas, 1965 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap och rehabilitering,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation
-
Stenager, Egon (författare)
-
Sellebjerg, Finn (författare)
-
Sondergaard, Helle Bach (författare)
-
for the SIMCOMBIN, investigators study (författare)
-
visa färre...
-
(creator_code:org_t)
- 2011
- 2011
- Engelska.
-
Ingår i: Lancet neurology. - 1474-4465. ; 10:8, s. 691-701
- Relaterad länk:
-
https://gup.ub.gu.se...
-
visa fler...
-
https://doi.org/10.1...
-
visa färre...
Abstract
Ämnesord
Stäng
- BACKGROUND: Treatment of relapsing-remitting multiple sclerosis with interferon beta is only partly effective. We aimed to establish whether add-on of simvastatin, a statin with anti-inflammatory properties, improves this efficacy. METHODS: We enrolled treatment-naive patients with relapsing-remitting multiple sclerosis in a multicentre, placebo-controlled, double-blind, randomised, parallel-group trial of simvastatin (80 mg daily) as add-on treatment to intramuscular interferon beta-1a (30 μg weekly). After starting treatment with interferon beta, patients were randomly assigned (in computer-generated blocks of four patients) to simvastatin 80 mg per day or placebo for 1-3 years. Patients and treating and evaluating physicians were masked to treatment allocation. The primary outcome measure was annual rate of documented relapses; analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00492765. FINDINGS: We randomly assigned 307 patients to interferon beta plus simvastatin (n=151) or plus placebo (n=156). Annual rate of documented relapses was 0·19 (95% CI 0·13 to 0·28) in the simvastatin group and 0·14 (95% CI 0·09 to 0·23) in the placebo group (absolute difference 0·059, 95% CI -0·21 to 0·09; p=0·35). Time to first documented relapse (20th percentile) was 18·1 months in patients on simvastatin and 21·5 months in those on placebo (hazard ratio 1·21, 95% CI 0·74 to 1·99; p=0·51). Mean number of new or enlarging T2 lesions was 2·96 in the simvastatin group and 2·52 in the placebo group (ratio of new lesions, 1·17, 95% CI 8·89 to 1·55; p=0·25). Eight (6%) patients on simvastatin and 17 (13%) on placebo had no disease activity (odds ratio 0·42, 95% CI 0·17 to 1·00; p=0·05). No unexpected adverse events were seen. Generally, adverse events were mild and there were no group differences in infections or musculoskeletal disorders, including myalgia (five [3%] patients on simvastatin and nine [6%] on placebo). Rhabdomyolysis and myoglobinuria were not reported and there were no differences in serum creatine phosphokinase. INTERPRETATION: We found no beneficial effect of simvastatin as add-on therapy to interferon beta-1a. Although unlikely, we can not exclude that combination of other statins with other disease-modifying drugs still could be beneficial. FUNDING: Biogen Idec.
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Sorensen, Per So ...
-
Lycke, Jan, 1956
-
Erälinna, Juha-P ...
-
Edland, Astrid
-
Wu, Xingchen
-
Frederiksen, Jet ...
-
visa fler...
-
Oturai, Annette
-
Malmeström, Clas ...
-
Stenager, Egon
-
Sellebjerg, Finn
-
Sondergaard, Hel ...
-
for the SIMCOMBI ...
-
visa färre...
- Artiklar i publikationen
-
Lancet neurology
- Av lärosätet
-
Göteborgs universitet