LONG-TERM PERFORMANCE OF LACOSAMIDE AS ADD-ON THERAPY IN THE CLINICAL SETTING: RESULTS FROM A PROSPECTIVE MULTICENTRIC STUDY IN CENTRAL SPAIN (LACASYMAD)
Abstract number :
2.123
Submission category :
4. Clinical Epilepsy
Year :
2012
Submission ID :
15690
Source :
www.aesnet.org
Presentation date :
11/30/2012 12:00:00 AM
Published date :
Sep 6, 2012, 12:16 PM
Authors :
J. Parra Gomez, F. J. Barriga Hern ndez, A. G mez Caicoya, V. Iv ez, P. A. Singer, F. Plaza Nieto, P. E. Bermejo Velasco, H. Bathal Guede, A. Mart n Araguz, A. Yusta Izquierdo0, F. J. Carod Artal, E. Toribio D az, D. Sagarra Mur, J. M. G mez Arg elles, M
Rationale: Post-marketing audit studies provide useful complementary information about safety and effectiveness helpful to guide current clinical practice. This study was set up to evaluate long-term security and efficacy profile of lacosamide (LCM) as add-on therapy in patients with non-controlled focal epilepsy in a routine clinical setting. Methods: A multicenter prospective, open-label, observational, follow-up study was performed. Epileptic patients not clinically controlled on monotherapy were recruited, and efficacy and tolerability of LCM as add-on therapy was analyzed. Data were prospectively collected by means of a standardized case report form in 14 hospitals from the autonomous communities Castile-La Mancha, Castile and León and Madrid. Patients were assessed at months 3, 6 and 12. Study end-points were: 1) seizure freedom for 6 months; 2) reduction rate higher than 50% in the mean number of complex partial and secondarily generalized seizures (definition of responder); 3) withdrawal due to lack of efficacy or side effects. Results: 155 patients were recruited (80 women; mean age: 45.8 years; mean duration of epilepsy: 18.1. years). 80% of the patients had tried 2-12 previous antiepileptic drugs (AEDs). Currently, 124 and 66 patients have been assessed at 6 and 12-month follow-up. By the 12-month assessment, 34.8% of patients (23/66) had been free of complex partial and secondarily generalized seizures for at least the preceding 3 months. Nineteen patients (28.8%) were seizure free for more than 6 months. Mean monthly seizure frequency at 12 months was significantly reduced from seizure frequency at baseline (12.3 ± 4.8 to 1.5± 0.4, p<0.0001, K-S test) with median LCM dose of 375 mg (range 50-500 mg). Seventeen patients discontinued LCM (70% in the first trimester) due to side effects (n= 10), lack of response (n=4) or both (n=3). No association was found between good response to LCM and drug load of sodium-channel-blockers and non-sodium channel-blockers AEDs. Conclusions: LCM maintains an efficacious and well-tolerated profile in the long-term treatment of focal epilepsy in combination with different AEDs regardless its mechanism of action.
Clinical Epilepsy