Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

Summary

This study is to find out if there is any benefit to adding Simvastatin to Interferon-beta-1a in patients with Multiple Sclerosis.

Timeline

Start

2006-02

Primary completion

2010-04

Completion

2010-04

Outcome

Missed primary endpoint

paper absolute difference 0·059, 95% CI -0·21 to 0·09; p=0·35). PMID 21742556 ↗

paper We found no beneficial effect of simvastatin as add-on therapy to interferon beta-1a. PMID 21742556 ↗

Publications

• Sorensen PS, Lycke J, Eralinna JP, Edland A, Wu X, Frederiksen JL, Oturai A, Malmestrom C, Stenager E, Sellebjerg F, Sondergaard HB; SIMCOMBIN study investigators. Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. Lancet Neurol. 2011 Aug;10(8):691-701. doi: 10.1016/S1474-4422(11)70144-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simvastatin	Small molecule	80 mg	Oral
Background	Interferon beta-1a	Protein / enzyme biologic	30 ug	Intramuscular

Indications