Randomized controlled trial of atorvastatin in clinically isolated syndrome: the STAyCIS study.

ABSTRACT:

Objective

To test efficacy and safety of atorvastatin in subjects with clinically isolated syndrome (CIS).

Methods

Subjects with CIS were enrolled in a phase II, double-blind, placebo-controlled, 14-center randomized trial testing 80 mg atorvastatin on clinical and brain MRI activity. Brain MRIs were performed quarterly. The primary endpoint (PEP) was development of ≥ 3 new T2 lesions, or one clinical relapse within 12 months. Subjects meeting the PEP were offered additional weekly interferon β-1a (IFNβ-1a).

Results

Due to slow recruitment, enrollment was discontinued after 81 of 152 planned subjects with CIS were randomized and initiated study drug. Median (interquartile range) numbers of T2 and gadolinium-enhancing (Gd) lesions were 15.0 (22.0) and 0.0 (0.0) at base

SUBMITTER: Waubant E 

PROVIDER: S-EPMC3320055 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature