Effects of rivastigmine on cognitive function in patients with traumatic brain injury.
OBJECTIVE
To compare the efficacy and safety of rivastigmine (3 to 6 mg/day) vs placebo over 12 weeks in patients with traumatic brain injury and persistent cognitive impairment.


METHODS
This prospective, randomized, double-blind, placebo-controlled study was conducted in 157 patients at least 12 months after injury. The primary efficacy measures were the Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing (RVIP) A' subtest and the Hopkins Verbal Learning Test (HVLT). The primary efficacy outcome was the proportion of patients who demonstrated 1.0 SD or greater improvement from baseline at week 12 on CANTAB RVIP A' or HVLT.


RESULTS
The percentage of responders at week 12 on either the CANTAB RVIP A' or HVLT was 48.7% for rivastigmine and 49.3% for placebo (p = 0.940). Furthermore, for the overall study population, there were no significant differences for any of the secondary efficacy variables. In a subgroup of patients with moderate to severe memory impairment (n = 81), defined as 25% impairment or greater on HVLT at baseline, rivastigmine was significantly better than placebo for a number of measures, including the proportion of HVLT responders and CANTAB RVIP mean latency.


CONCLUSIONS
Rivastigmine was safe and well tolerated in patients with traumatic brain injury with cognitive deficits. Rivastigmine shows promising results in the subgroup of patients with traumatic brain injury with moderate to severe memory deficits.
Silver
J M
JM
New York University School of Medicine, New York, NY, USA.
Koumaras
B
B
Chen
M
M
Mirski
D
D
Potkin
S G
SG
Reyes
P
P
Warden
D
D
Harvey
P D
PD
Arciniegas
D
D
Katz
D I
DI
Gunay
I
I
D000293:Adolescent; D000328:Adult; D000932:Antiemetics / Q000627:therapeutic use; D001549:Benzamides / Q000627:therapeutic use; D001930:Brain Injuries / Q000150:complications / Q000188:drug therapy*; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D048448:Phenylcarbamates / Q000627:therapeutic use*; D011446:Prospective Studies; D000068836:Rivastigmine; D016896:Treatment Outcome; D014839:Vomiting / Q000188:drug therapy / Q000209:etiology
D000932:Antiemetics; D001549:Benzamides; D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D000068836:Rivastigmine; C100146:trimethobenzamide