Pregabalin Efficacy and Tolerability in Patient with Intractable Partial Seizures Post-Marketing
Abstract number :
2.157
Submission category :
Antiepileptic Drugs-Adult
Year :
2006
Submission ID :
6596
Source :
www.aesnet.org
Presentation date :
12/1/2006 12:00:00 AM
Published date :
Nov 30, 2006, 06:00 AM
Authors :
John M. Seeley, Amir Arain, Martin Gallagher, and Bassel Abou-Khalil
More than 30% of patients with partial epilepsy are resistant to standard antiepileptic drugs (AEDs). Those who are not candidates for epilepsy surgery would benefit from add-on trials of newer AEDs. Pregabalin (PGB) is a new AED with 40-50% responder rate and only 15% drop out rate in add-on clinical trials. Efficacy and tolerability in clinical practice after marketing can be different. We analyzed efficacy and tolerability of add-on PGB in all patients started on PGB between September 2005 and February 2006., The patient records were retrospectively reviewed for all patients who were started on PGB between September 2005 and February 2006 in Dr. Bassel Abou-Khalil[apos]s epilepsy clinic. The records were analyzed to investigate PGB[apos]s efficacy, safety, and tolerability in relation to patient demographics, seizure, and epilepsy characteristics, starting dose, titration rate, target dose, and concomitant treatment. In addition, other factors such as age, response to previous treatment, duration of treatment, and adverse experiences were recorded. Outcome was measured in one of the following five categories; seizure free, marked improvement ([gt] 90 % reduction in seizure frequency), moderate improvement (50-90% reduction in seizure frequency), no significant change (less than 50% reduction in seizure frequency), or worsened seizure frequency., There were 55 patients who were started on PGB between September 2005 and February 2006. The age ranged from 17 to 70 with an average age of 40. 70% of the patients were still taking PGB at the time of last follow up with an average duration of treatment of 25 weeks. 30% of the patients started on PGB were no longer taking it. 25% of the patients who discontinued the medication, did so for ineffectiveness only while the other 75% stopped the medication for either ineffectiveness and adverse effects or adverse effects alone. The average length of treatment for those who discontinued PGB was 11 weeks. The most common adverse effect causing discontinuation was drowsiness (42%), emotional lability and irritability (33%). 52% of the patients complained of an adverse effect. The most common adverse effect overall for the patients was drowsiness (20%) and weight gain (13%). The average number of AEDs when starting PGB was 2.1. The patients had failed an average of 7 AEDs in the past. Seven of the patients had not had follow up as of yet. Of the remaining 48 patients, the responder rate was 49% with 8% of those becoming seizure free., In patients with refractory partial seizures, adjunctive therapy with PGB is effective and well tolerated. The most common adverse effects were drowsiness and weight gain. The most common adverse effect causing discontinuation of therapy was drowsiness and irritability and this was not related to starting dose or titration rate.,
Antiepileptic Drugs