MULTICENTRIC RETROSPECTIVE ANALYSIS OF THE EFFICACY AND SAFETY OF TOPIRAMATE AS AN ADD-ON THERAPY ACCORDING TO THE TOPOGRAPHIC FORM OF FOCAL EPILEPSY
Abstract number :
2.187
Submission category :
Year :
2002
Submission ID :
1320
Source :
www.aesnet.org
Presentation date :
12/7/2002 12:00:00 AM
Published date :
Dec 1, 2002, 06:00 AM
Authors :
Pierre Genton, Arnaud Biraben, Philippe Bouhours. Centre St Paul, Hopital H. Gastaut, Marseille, France; Neurology Department, CHU de Rennes, Rennes, France; Janssen-Cilag France, Issy les Moulineaux, France
RATIONALE: The objective of this study was to evaluate, in clinical practice, the effacy of topiramate (TPM) in partial epilepsy considering its topographic form. Safety of TPM was also assessed.
(A.Biraben and P. Genton. Rev Neur (Paris) 2000 ; 156 : 11; 993-999)
(P. Genton and A.Biraben. Rev Neur (Paris) 2000 ; 156 : 12; 1120-1125)
METHODS: Data trom 361 patients were collected by 70 investigators in this retrospective, multicentric, open, pragmatic study. Tolerability was assessed in these 361 patients. 237 patients were treated during at least 3 monthsby TPM, and efficacy was evaluated in these patients considering the topographic form of the epilepsy.
RESULTS: TPM was titrated slowly (mean rate: 43 mg/week) and was given at a final dose of 346 mg/day. TPM was prescribed as an add-on therapy with 1 anti-epileptic drug (AED) for 12 % of patients and 87 % with at least 2 other AEDs.
52.7 % of patients were considered as responders (9.3 % seizure free). Topographic form analysis showed there were responders in all topographic groups. A good response was observed in epilepsia originating from the central areas, which are ofen drug-resistant (19 % of seizure free, 66.6 % of responders).
On the safety analysis population (n=361), 64 % of the patients reported at least one adverse event (AE) which lead to treatment withdrawal in only 18.5 % of the patients. AEs were mostly CNS related (somnolence: 16.1 %, fatigue: 11.9 %) and weight loss (14.7 %, mean 4.5 Kg or 6.6 % of body weight). Withdrawal of TPM was caused by AE (13.6 %), lack of efficacy (8.3 %), seizure worsening (6.1 %) or by a combination of these (5%).
CONCLUSIONS: This analysis confirmed the efficacy of TPM as add-on therapy in focal epilepsy in clinical practice. TPM seems also to be efficient in all the topographic form assessed in this study, with good results in epilepsy originating from central areas.
Considering a slower titration profile, we also observed a better safety profile for TPM compared to controlled studies.
[Supported by: This study was done with the support of Janssen-Cilag France]; (Disclosure: Salary - Philippe Bouhours, salary from Janssen-Cilag)