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Effects of rivastigmine on cognitive function in patients with traumatic brain injury

From New York University School of Medicine, New York, NY (J.M.S.); Novartis Pharmaceuticals, East Hanover, NJ (B.K., M.C., D.M., I.G.); University of California, Irvine Medicine Center, Orange, CA (S.G.P.); Creighton University School of Medicine, Omaha, NE (P.R.); Walter Reed Army Medical Center, Washington, DC (D.W.); Mt. Sinai School of Medicine, New York, NY (P.D.H.); University of Colorado Health Sciences Center, Denver, CO (D.A.); Boston University School of Medicine, Boston, MA (D.I.K.); and Healthsouth Braintree Rehabilitation Hospital, Braintree, MA (D.I.K.).

Address correspondence and reprint requests to Dr. Ibrahim Gunay, Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936; e-mail: ibrahim.gunay{at}novartis.com

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.

Commentary, see page 733

See also page 756

Disclosure: This study was supported by Novartis Pharmaceuticals Corporation. J. Silver has received honoraria from Novartis. B. Koumaras is an employee of Novartis and owns equity interest. M. Chen is an employee of Novartis. D. Mirski is a former employee of Novartis, owns equity interest, and has received honoraria from Novartis. S. Potkin has received grants and honoraria (in excess of $10,000) from Novartis. P. Reyes has received grants (in excess of $10,000) and honoraria (in excess of $10,000) from Novartis. D. Warden has nothing to disclose. P. Harvey has received honoraria from Novartis. D. Arciniegas has received educational grants (in excess of $10,000) and honoraria (in excess of $10,000) from Novartis and has given expert testimony related to the subject of the study. D. Katz has nothing to disclose. I. Gunay is an employee of Novartis.

Disclaimer: The views expressed in this paper are those of the author and do not reflect the official policy of the Department of the Army, Department of Defense, or US Government.

Received October 5, 2005. Accepted in final form May 5, 2006.

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