Long-term effects of rivastigmine capsules in patients with traumatic brain injury.
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 (< or =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 (> or =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.
Silver
Jonathan M
JM
New York University School of Medicine, New York, NY, USA.
Koumaras
Barbara
B
Meng
Xiangyi
X
Potkin
Steven G
SG
Reyes
Patricio F
PF
Harvey
Philip D
PD
Katz
Douglas I
DI
Gunay
Ibrahim
I
Arciniegas
David B
DB
D000328:Adult; D001930:Brain Injuries / Q000150:complications* / Q000503:physiopathology; D002214:Capsules; D003072:Cognition Disorders / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D009483:Neuropsychological Tests; D048448:Phenylcarbamates / Q000008:administration & dosage* / Q000009:adverse effects; D000068836:Rivastigmine; D013995:Time; D016896:Treatment Outcome
D002214:Capsules; D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D000068836:Rivastigmine