ANALYSIS OF PREGABALIN AND LACOSAMIDE USING THE POST-MARKETING ANTIEPILEPTIC DRUG/DEVICE SURVEY
Abstract number :
3.125
Submission category :
4. Clinical Epilepsy
Year :
2012
Submission ID :
15423
Source :
www.aesnet.org
Presentation date :
11/30/2012 12:00:00 AM
Published date :
Sep 6, 2012, 12:16 PM
Rationale: To assess the use of new antiepileptic drugs (AEDs) in everyday clinical practice outside of the research setting using an industry-independent design. Patient characteristics, titration rates, comorbidity of diseases, and other factors during clinical trials may differ from those in a clinical practice. By reporting a retrospective-usage of new antiepileptic medications of Pregabalin and Lacosamide, we will be able to determine drug efficacy and response across a large population. Methods: Patients, who have recently started Pregabalin or Lacosamide at the Regional Epilepsy Center, will be identified and deemed eligible by the treating physician and/or clinic staff. Eligible subjects will be assigned a subject profile entailing the subject's name, medical record number and the clinical site of treatment. Data collection can be completed using either the PADS paper forms, available as PDF files on the PADS website, or by entering information directly into the PADS webpage. Forms include an intial assessment, where subjects were first prescribed the drug, followed by a six-month follow-up form. Study personnel will complete the study forms by compiling clinically relevant information from the subject's medical chart. Data analysis will occur retrospectively (i.e.after both the initial and follow-up clinic visits have taken place) and will not affect the subject's treatment course. Information will be entered into the PADS database only after the six-month follow-up forms are concluded, after which the subject is considered complete. A review of 250 subjects taking each medication was made. A total of 342 subjects met all study enrollment criteria. Results: A total of 342 patients were entered into the database: 170 Pregabalin; 172 Lacosamide with the average age of the patient being 43 and an average age of onset of 17 years old. Most of the patients treated had localization related epilespy syndromes (267) with a sparse number of primary generalized syndromes (28). The average intial seizure frequency of patients surveyed on pregabalin and lacosamide were 5.7 complex partial seizures (CPS) and 5 CPS per month, respectively . Average dose intake for pregabalin and lacosamide AEDs were 320mg and 363mg per day respectively. The final CPS frequency after 6 months were 3.7 and 3.4 for pregabalin and lacosamide respectively. Seizure and global assessment of patients surveyed after their 6 month follow-up varied slightly from one another. The "better" or "much better" seizure assessments occurred in 34% of pregabalin patients and 55% of lacosamide patients. However, global assessments of "better" or "much better" were 15% for pregabalin and 29% for lacosamide. Interestingly, the retention rate for pregabalin and lacosamide were 92 and 86 percent respectively. Conclusions: Pregabalin and lacosamide were effective in reducing seizures and well tolerated based on high retention rates. Improved seizure assessments may suggest why patients remained on the drugs while tolerating some adverse experiences that lower their overall global assessment.
Clinical Epilepsy