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From the Department of Neurology (Drs. Meador and Loring), Georgetown University, Washington, DC; Department of Neurology (V.J. Vahle and Dr. Fessler), Washington University, St. Louis, MO; Department of Neurology (Dr. Ray), Medical College of Georgia, Augusta; Department of Neurology (Drs. Werz, Ogrocki, and Schoenberg), University Hospitals of Cleveland and Case Western Reserve University, OH; and GlaxoSmithKline (Drs. Miller and Kustra), Research Triangle Park, NC.
Address correspondence and reprint requests to Dr. Kimford J. Meador, Department of Neurology, University of Florida, McKnight Brain Institute (L3-100), 100 South Newell Drive, Gainesville, FL 32611; e-mail: kimford.meador{at}neurology.ufl.edu
Background: The relative cognitive and behavioral effects of lamotrigine (LTG) and topiramate (TPM) are unclear.
Methods: The authors directly compared the cognitive and behavioral effects of LTG and TPM in 47 healthy adults using a double-blind, randomized crossover design with two 12-week treatment periods. During each treatment condition, subjects were titrated to receive either LTG or TPM at a target dose of 300 mg/day for each. Neuropsychological evaluation included 17 measures yielding 41 variables of cognitive function and subjective behavioral effects. Subjects were tested at the end of each antiepileptic drug (AED) treatment period and during two drug-free conditions (pretreatment baseline and 1 month following final AED withdrawal).
Results: Direct comparison of the two AEDs revealed significantly better performance on 33 (80%) variables for LTG, but none for TPM. Even after adjustment for blood levels, performance was better on 19 (46%) variables for LTG, but none for TPM. Differences spanned both objective cognitive and subjective behavioral measures. Comparison of TPM to the non-drug average revealed significantly better performance for non-drug average on 36 (88%) variables, but none for TPM. Comparison of LTG to non-drug average revealed better performance on 7 (17%) variables for non-drug average and 4 (10%) variables for LTG.
Conclusions: Lamotrigine produces significantly fewer untoward cognitive and behavioral effects compared to topiramate (TPM) at the dosages, titrations, and timeframes employed in this study. The dosages employed may not have been equivalent in efficacy. Future studies are needed to delineate the cognitive and behavioral effects of TPM at lower dosages.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the June 28 issue to find the title link for this article.
Supported by a grant from Glaxo SmithKline.
J.M. Miller and R.P. Kustra are employees of GlaxoSmithKline and hold equity in the company. K.J. Meador and M.A. Werz have received grants from GlaxoSmithKline separate from the present study grant. (Both received grants in excess of $10,000.) K.J. Meador and M.A. Werz have received honoraria from GlaxoSmithKline. (K.J. Meador’s honoraria was in excess of $10,000.) This study was funded by a grant from GlaxoSmithKline. The study was investigator-initiated, and the design was initiated by investigators separate from the study sponsor. Two of the investigators are employees of GlaxoSmithKline. They provided input in the dosing and titration of medications as well as exclusion criteria for subjects. They also coordinated training, enrollment, data collection, and data submission across centers. The data were collected by the investigators at the individual sites, and the analyses were conducted separate from GlaxoSmithKline. All investigators participated in the preparation of the manuscript after the initial draft was prepared by the corresponding author.
Presented in part at the 2004 annual meeting of the American Academy of Neurology; San Francisco, CA.
Received September 21, 2004. Accepted in final form February 16, 2005.
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