Long-term effects of rivastigmine capsules in patients with traumatic brain injury

Jonathan M. Silver, Barbara Koumaras, Xiangyi Meng, Steven G. Potkin, Patricio F. Reyes, Philip D. Harvey, Douglas I. Katz, Ibrahim Gunay, David B. Arciniegas

Research output: Contribution to journalArticlepeer-review

42 Scopus citations

Abstract

Objective: To investigate the safety, tolerability and efficacy of rivastigmine capsules (3-12 mg/day) in a 26-week, multi-centre, open-label extension of a double-blind study. Methods: Patients with traumatic brain injury (TBI) and persistent cognitive impairment who had received rivastigmine (3-6 mg/day) or placebo for 12 weeks could enter the extension study and receive rivastigmine (≤12 mg/day). Patients were assessed using a range of cognitive tests including the Hopkins Verbal Learning Test (HVLT) and the Cambridge Neuropsychological Test Automated Battery Rapid Visual Information Processing (CANTAB RVIP) A' sub-test. Safety measures included monitoring of adverse events. Results: In the extension study (n = 127), the mean duration of rivastigmine treatment was 23.8 weeks and the mean final dosage was 7.9 mg/day. Approximately 40% of patients were responders (≥1.0 SD improvement from baseline) on CANTAB RVIP A' or HVLT total score at week 38 or endpoint. Statistically significant changes from week 12 at week 38 were observed for CANTAB-RVIP A' and HVLT-total word recall for the sub-group of ex-placebo patients with greater severity of initial impairment. The safety profile of rivastigmine capsules was consistent with the label. Conclusions: Treatment with rivastigmine for up to 38 weeks was safe in patients with TBI and cognitive impairment.

Original languageEnglish (US)
Pages (from-to)123-132
Number of pages10
JournalBrain Injury
Volume23
Issue number2
DOIs
StatePublished - Jan 1 2009
Externally publishedYes

Keywords

  • Efficacy
  • Open-label extension
  • Rivastigmine
  • Safety
  • Traumatic brain injury

ASJC Scopus subject areas

  • Clinical Neurology

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