Safety of Lacosamide for Hospitalized Patients with Seizures
Abstract number :
2.180
Submission category :
7. Antiepileptic Drugs
Year :
2010
Submission ID :
12774
Source :
www.aesnet.org
Presentation date :
12/3/2010 12:00:00 AM
Published date :
Dec 2, 2010, 06:00 AM
Authors :
Marilyn Luk, W. Freeman, A. Patel, W. Tatum and K. Nau
Rationale: Lacosamide (LCM) is a novel antiepileptic drug with favorable properties including intravenous (IV) formulation, minimal hepatic metabolism, minimal protein binding and no adverse respiratory or hemodynamic effects. Little is known regarding LCM therapy in hospitalized patients with regard to hemodynamic profile and adverse events. Methods: We retrospectively reviewed electronic medical records for patients treated with LCM at a single tertiary-care academic medical center (Mayo Clinic Florida) from July 2009 to January 2010. Collected data included age, sex, indication, dosing regimen, primary medical service, concomitant AED therapy, and documented seizure activity (clinical diagnosis or EEG). Safety was assessed by pre- and post-drug hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean PR interval) as well as laboratory parameters including serum creatinine (SCr) and liver function tests (LFTs). Adverse drug reactions or drug interactions were assessed as reported by clinical documentation. Results: We identified 32 patients treated with LCM during the study period (17 treated in the ICU). Twelve patients received LCM for seizure prophylaxis whereas 20 received LCM for seizure treatment. Twenty-five patients received LCM by IV route, 19 underwent IV to PO, and 7 patients received LCM by PO route only. The majority of seizure patients (n=20; 62.5%) received LCM as adjunctive therapy whereas 12 patients (37.5%) received LCM as monotherapy. No hemodynamic instability, serious cardiac arrhythmias, cardiac or respiratory arrest occurred in any patient who received LCM. ECGs in selected patients demonstrated a mean (SD; range) PR interval of 185.5 ms (33.1; range 148-254) after drug initiation compared to a baseline of 179.3 ms (47.5; range 80-274). Laboratory data revealed no clinically significant changes in baseline and 24hr post-drug SCr or LFTs. No drug interactions were identified and adverse events were reported in three patients (9.4%). One patient complained of dizziness and nausea , one had alteration in mental status with PR interval prolongation (212 ms vs 178 ms baseline). One patient experienced thrombocytopenia of unknown etiology while receiving LCS. All adverse events resolved after drug discontinuation. Conclusions: LCM demonstrated a favorable hemodynamic safety profile for hospitalized patients. Nine percent experienced adverse events while receiving LCM that resolved in all cases upon drug discontinuation. Future prospective studies are needed to assess safety of LCM in hospitalized patients.
Antiepileptic Drugs