Lacosamide efficacy and tolerability in clinical practice – Post marketing analysis from a single dedicated epilepsy center
Autor: | Nabil J. Azar, Bassel Abou-Khalil, Mark D. Baker, Amir Arain, Kevin F. Haas, Pavan Tummala, Hasan H. Sonmezturk |
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Rok vydání: | 2018 |
Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Lacosamide Cohort Studies Young Adult 03 medical and health sciences Epilepsy 0302 clinical medicine Seizures Internal medicine medicine Humans Adverse effect Aged Response rate (survey) business.industry General Medicine Middle Aged medicine.disease Discontinuation Clinical trial Treatment Outcome 030104 developmental biology Tolerability Cohort Anticonvulsants Drug Therapy Combination Female Surgery Epilepsies Partial Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
Zdroj: | Clinical Neurology and Neurosurgery. 171:179-183 |
ISSN: | 0303-8467 |
DOI: | 10.1016/j.clineuro.2018.06.022 |
Popis: | Objectives Post marketing analysis of anti-epileptic drug (AED) efficacy and tolerability is of great value to the clinician since it is more representative of clinical practice than clinical trial data. We analyzed our experience with lacosamide (LCM) in patients treated after marketing. Patients and methods We identified all patients who were treated with LCM during the four year period after marketing, excluding patients who were in clinical trials. We recorded demographic data and analyzed efficacy and tolerability in patients who had at least one follow up visit or telephone call 3 months after the initiation of LCM. Results A total of 165 patients met our inclusion criteria. The mean age was 41 years. The majority of the cohort had focal epilepsy (146 patients) (88.4%). The mean duration of treatment was 31.2 months. Eighty one patients (49.1%) were continuing LCM at last follow up. Adverse effects (AEs) and discontinuation were significantly more common when LCM was added to one or more Na-channel blocking agents (NCB) (p = 0.0003 and 0.17). The 50% responder rate was 26% at 3 months and increased to 49% at 36 months. Patients were more likely to continue the drug and less likely to have AEs with slower titration over > 4 weeks (p = 0.02 for each). Four or more previously failed AEDs predicted poorer response rate compared to three or less AEDs (p = 0.001). Conclusion LCM use in clinical practice was associated with greater rate of seizure freedom than in clinical trials. Discontinuation and occurrence of AEs were significantly more likely with faster titration and adding LCM to NCB agents. |
Databáze: | OpenAIRE |
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