Abstract Details

Title Long-term Tolerability of Lacosamide and Controlled-release Carbamazepine Monotherapy by Number of Additional Medical Conditions: A Post Hoc Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) S3 - Epilepsy/Clinical Neurophysiology (EEG) I (2:17 PM-2:28 PM)

Poster/Presentation
Number 008

Background People with epilepsy have a higher prevalence of comorbid conditions than the general population. The presence of comorbid conditions may complicate epilepsy management and treatment.

Objective To assess the long-term tolerability of lacosamide (LCM) and carbamazepine controlled-release (CBZ-CR) monotherapy in adults with newly diagnosed epilepsy by number of comorbid conditions.

Design/Methods Post hoc analysis of pooled data from SP0993 (NCT01243177) and the double-blind extension (SP0994; NCT01465997). SP0993 enrolled adults (≥16 years) with newly diagnosed epilepsy (focal or generalized tonic-clonic seizures). LCM and CBZ-CR were initiated at 100mg/day or 200mg/day, respectively, and titrated to a target dose of 200mg/day (LCM) or 400mg/day (CBZ-CR), with increases to 400/600mg/day (LCM) and 800/1200mg/day (CBZ-CR), if needed. Patient subgroups were based on the number of comorbid conditions at the Screening Visit (0, 1-2, ≥3). Outcomes of interest included drug-related treatment-emergent adverse events (TEAEs) and discontinuations due to TEAEs for each subgroup.

Results

Of 886 patients treated in the combined trials (LCM: 444; CBZ-CR: 442), 245 patients (27.7%) had no comorbid conditions, 305 (34.4%) had 1-2 comorbid conditions, and 336 (37.9%) had ≥3 comorbid conditions. The incidence of drug-related TEAEs and discontinuations due to TEAEs increased by number of comorbid conditions, which was less pronounced in patients on LCM (overall drug-related TEAEs: LCM 40.8%, CBZ-CR 50.2%; discontinuations due to TEAEs: LCM 13.1%, CBZ-CR 19.0%). These findings were supported by the Kaplan-Meier estimated proportions of patients that did not discontinue treatment due to TEAEs at 1 and 2 years.

Conclusions

Data from this post hoc analysis suggest an increased incidence of drug-related TEAEs and discontinuations due to TEAEs with higher number of comorbid conditions, which was less pronounced with LCM vs CBZ-CR monotherapy. These results may help clinicians determine appropriate treatment approaches for their patients with epilepsy and comorbid conditions.

Authors/Disclosures
Teresa D. Gasalla, MD (UCB Biosciences Inc) PRESENTER	Dr. Gasalla has received personal compensation for serving as an employee of UCB Biosciences Inc. Dr. Gasalla has stock in UCB Pharma.
Elinor Ben-Menachem, MD, FAAN (Dept of Clinical Neuroscience)	Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arvelle. Dr. Ben-Menachem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharma. Dr. Ben-Menachem has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Acta Neurologica Scandinvica. The institution of Dr. Ben-Menachem has received research support from zogenic.
	No disclosure on file
	No disclosure on file
Lori Jensen	No disclosure on file
	No disclosure on file
Marc De Backer, MD, FBCPM, MBA	No disclosure on file
Melissa Brock (SCHWARZ BIOSCIENCES, Inc.)	No disclosure on file
Victor Biton, MD (AEP)	Dr. Biton has nothing to disclose.

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