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The highly anticipated primary results of the phase 3 MS-STAT2 trial failed to show that high-dose simvastatin slows disability progression in secondary progressive MS (SPMS). Simvastatin treatment was safe and well tolerated. More analyses are to come.
The results of the MS-STAT2 trial (NCT03387670) were presented as a late-breaking abstract by Jeremy Chataway, MA, PhD, from the University College London, in the UK1. This study in patients with SPMS was stimulated by the positive outcomes of the phase 2b MS-STAT trial (NCT00647348), which demonstrated a reduction of 43% in the mean rate of whole brain atrophy over 2 years in patients with SPMS, with simvastatin 80 mg/day2.
MS-STAT2 is a multicenter, randomized-controlled trial conducted at 31 hospital sites in the UK. Inclusion criteria were the same as in the MS-STAT trial. Participants had to be 25 to 65 years of age and have an Expanded Disability Status Scale (EDSS) score of 4.0 to 6.5. Patients had SPMS with steady progression rather than relapse as the major cause of increasing disability in the preceding 2 years. The participants were randomly assigned to simvastatin 80 mg (40 mg in the first month) or matching placebo for up to 4.5 years. The primary outcome was confirmed disability progression.
The mean age of the 964 enrolled participants was 54 years, 73% were women, and the mean duration of MS was 23 years. Only 5% had had relapse activity in the previous year. Compliance was over 80%.
“There was no effect of simvastatin on the progression rate in this population of patients with progressing MS,” Prof. Chataway said. “The cumulative incidence of progression was 40%.” The hazard ratio (HR) versus placebo was 1.13 (95% CI 0.91–1.31; P=0.26). A total of 365 progression events were confirmed.
Prof. Chataway summarized that the safety data was “excellent.” Many more (secondary) outcomes will be reported in the months to come, including analyses of patient-reported outcomes, biofluid markers, and MRI.
Medical writing support was provided by Michiel Tent
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