Intravenous carbamazepine as short‐term replacement therapy for oral carbamazepine in adults with epilepsy: Pooled tolerability results from two open‐label trials

Summary Objective To report tolerability findings and maintenance of seizure control from a pooled analysis of phase I open‐label trial OV‐1015 (NCT01079351) and phase III study 13181A (NCT01128959). Methods Patients receiving a stable oral dosage of carbamazepine were switched to an intravenous (IV...

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Bibliographic Details
Published in:Epilepsia (Copenhagen) 2015-06, Vol.56 (6), p.906-914
Main Authors: Lee, Deborah, Kalu, Uwa, Halford, Jonathan J., Biton, Victor, Cloyd, James, Klein, Pavel, Bekersky, Ihor, Peng, Guangbin, Dheerendra, Suresh, Tolbert, Dwain
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Anticonvulsants - administration & dosage
Carbamazepine - administration & dosage
Cyclodextrin
Drug Administration Schedule
Drug-Related Side Effects and Adverse Reactions
Epilepsy
Epilepsy - drug therapy
Female
Humans
Injections, Intravenous
Intravenous carbamazepine
Male
Middle Aged
Time Factors
Tolerability
Treatment Outcome
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Summary:Summary Objective To report tolerability findings and maintenance of seizure control from a pooled analysis of phase I open‐label trial OV‐1015 (NCT01079351) and phase III study 13181A (NCT01128959). Methods Patients receiving a stable oral dosage of carbamazepine were switched to an intravenous (IV) carbamazepine formulation solubilized in a cyclodextrin matrix (at a 70% dosage conversion) for either a 15‐ or a 30‐min infusion every 6 h for up to 7 days and then switched back. A subset of patients who tolerated 15‐min infusions also received 2‐ to 5‐min (rapid) infusions. Assessments included physical and laboratory evaluations, electrocardiography (ECG) studies, as well as adverse event (AE) monitoring for tolerability. Convulsion/seizure AE terms and data from seizure diaries were used as proxies for the assessment of consistency of seizure control between formulations. Results Of the 203 patients exposed to IV carbamazepine (30 min, n = 43; 15 min, n = 160), 113 received 149 rapid infusions. During infusion, the most commonly reported AEs (≥5%) were dizziness (19%), somnolence (6%), headache (6%), and blurred vision (5%). IV carbamazepine was not associated with clinically relevant cardiac AEs. The tolerability profile appeared similar between patients who received
ISSN:0013-9580
1528-1167
DOI:10.1111/epi.12991