TOLERABILITY AND SAFETY OF TOPIRAMATE IN JUVENILE MYOCLONIC EPILEPSY
Abstract number :
2.364
Submission category :
Year :
2004
Submission ID :
4813
Source :
www.aesnet.org
Presentation date :
12/2/2004 12:00:00 AM
Published date :
Dec 1, 2004, 06:00 AM
Authors :
Patr[iacute]cia S. Sousa, Eliana Garzon, Américo C. Sakamoto, and Elza M.T. Yacubian
It has been suggested that valproate (VPA), considered the drug of choice in the treatment of Juvenile Myoclonic Epilepsy (JME), may affect reproductive function in women with epilepsy. Topiramate (TPM) may represent a therapeutic alternative since it has an equally broad profile. Some studies have suggested the effectiveness of TPM in the control of generalized tonic-clonic seizures (GTCS), although a few have demonstrated its efficacy in the control of absences and myoclonic seizures. This is the preliminary report of the results of an ongoing two-year prospective study for evaluation of TPM in a series of patients with JME. TPM was administered as a first drug or as a substitute drug in the treatment of 22 patients (13-53 yr.; mean 23.2) with a confirmed diagnosis of JME. These were divided into three groups. Groups 1 and 2 included patients already being treated with other AED and were constituted by: (1) patients with seizure control but presenting side effects; (2) patients with non-controlled seizures and (3) patients with newly diagnosed JME. TPM was titrated according to patients[rsquo] response over 12-14 weeks and maintained for an additional 32 weeks. Target TPM dose was 100-200 mg/day. The patients were evaluated in the 2nd, 4th, 6th, 8th and 12th weeks and then in the 6th, 9th and 12th months as therapeutic effect and adverse events. 22 patients (18 females) were enrolled, 16 of which completed the first year of the follow-up. 14/22 patients in this series were already being treated with other AED without seizure control. Discontinuations were due to inadequate seizure control and adverse events (N=3), low compliance and loss of follow-up (N=3). Mean dosage was 106.25[plusmn] 55.43 mg/day. More specifically, in Group 1, 3 out of 5 patients remained seizure free, 1 presented an only seizure due to non-compliance and 1, seizure aggravation. In Group 2, 9 out of 14 patients showed [gt] 50% seizure reduction, 4 presented seizure aggravation, and the seizure frequency persisted unaltered in one patient. Lastly, in Group 3, 2 out of 3 patients remained seizure-free and one presented persisting myoclonias when exposed to precipitant factors. Myoclonias also persisted in 10 patients of Groups 1 and 2. In this series, 5 patients also presented absences. Regarding this seizure type, it disappeared in one, there was [gt] 50% seizure reduction in 2 and aggravation in the other 2 patients. The most common side effects observed were thirsty/dry mouth, paraesthesia, weight loss, appetite decrease, somnolence, headache, facial rubor, humor instability and language problems. TPM reduced the frequency of seizures in approximately 2/3 of patients with JME in the first year of follow-up seeming more effective in the control of GCTS. (Supported by JANSSEN-CILAG FARMAC[Ecirc]UTICA DO BRASIL, FAPESP (Funda[ccedil][atilde]o de Amparo a Pesquisa do Estado de S[atilde]o Paulo), CAPES (Coordena[ccedil][atilde]o de Aperfei[ccedil]oamento de Pessoal de N[iacute]vel Superior))