Psychiatric Adverse Events Caused by Topiramate and Lamotrigine: A Postmarketing Prevalence and Risk Factor Study
Abstract number :
G.10
Submission category :
Year :
2000
Submission ID :
740
Source :
www.aesnet.org
Presentation date :
12/2/2000 12:00:00 AM
Published date :
Dec 1, 2000, 06:00 AM
Authors :
Andres M Kanner, Faught Edward, French A Jaqueline, Tatum I William, Morris L George, Liporace Joyce, Blaise F D Bourgeois, William Rosenfeld, Cynthia Harden, Georgia Montouris, Michael D Privitera, Robert Burgerman, Rush-Presbyterian Saint Luke's Medical
RATIONALE: Topiramate (TPM) is an AED with the potential for cognitive adverse events (CAE). Its use in psychiatric disorders is been investigated. Lamotrigine has therapeutic effects in Bipolar disorders. Yet, the type and prevalence of psychiatric adverse events (PAE) associated with these AEDs in large cohorts of pts. has yet to be established. The purpose of this study is to identify the type and prevalence of PAE in patients with intractable epilepsy treated with TPM and LTG and to identify their risk factors. METHODS: We evaluated prospectively 787 pts. and 433 pts. treated with TPM and LTG, respectively used as add-on AED. Data were collected by investigators from 14 U.S. Epilepsy Centers (P.A.D.S. group) in standardized forms completed at the start, at six-month intervals and/or at discontinuation of the AED. PAE were grouped into: Mood, Behavior, Psychotic and Anxiety Disorders. CAE were identified separately. The risk factors for PAE included: Dose and titration rate of AED, neuropsychiatric hx., number of concomitant AED, AED with known negative psychotropic properties (i.e., phenobarbital, primidone, etc.) and CAE. RESULTS: TPM:91 of 787 pts. (11.6%)had PAE: 36 (4.6%) reported mood and 43 (5.5%)behavior disorders, 10 (1.3%) psychosis and 2 (0.25%) anxiety diosrder. PAE resulted in d/c of TPM in 40 of the 91(44%)pts. with PAE or 5.1% of all pts. 22 (24%) of the 91 pts. with PAE and 85 of the remaining 696 pts. had CAE. This was the only variable associated with PAE occurrence (X2=8.8, p=0.003). LTG:28 of the 433 (6.5%) pts. treated with LTG reported PAE: 15 (3.5%) behavior diosrder, 8 (1.9%) mood disorders, 4 (0.9%) psychosis and 1 (0.2%) anxiety disorder. PAE resulted in d/c of LTG in 5 of the 28 (18%) pts. with PAE or 1.1% of all pts. 20 of the 28 pts. with PAE (71.5%) and 178 (44%) of the remaining 405 pts. had a neuropsychiatric hx. This was the only variable associated with PAE occurrence (X2=6.9, p=0.009). CONCLUSIONS: PAE appear to occur twice as frequently with TPM than LTG, when used in polytherapy regimens for the treatment of intractable epilepsy. A neuropsychiatric hx. does not appear to be a risk factor for TPM, but it may be for LTG.