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Extended-release Oxcarbazepine Safe, Effective Over Long-Term: Presented at AES

By Bonnie Darves

BOSTON, MA -- December 15, 2003 -- Concerns about the safety of the antiepileptic drug oxcarbazepine (Trileptal) have discouraged its use, despite the drug's effectiveness as monotherapy in the treatment of partial seizures. Some of the safety issues, however, may be addressed and more manageable if patients take the extended-release version, according to a new study presented here December 9^th at the American Epilepsy Society 57^th Annual Meeting.

In a combined analysis of 170 patients over the 4-year period, researchers from the New York University Comprehensive Epilepsy Program and 2 other U.S. centres found that oxcarbazepine is both safe and effective -- as both monotherapy and adjunctive therapy -- over the long term. "It's important for physicians to know that this drug can be safely used for long-term treatment in both adults and children, since that's always a concern," said Blanca Vasquez, MD, assistant professor of neurology, New York University, United States. "The other important [finding] is that the drug maintains its efficacy."

The analysis of 2 multicentre, randomised, double-blind studies included 170 patients (mean age 35) with a median baseline seizure rate of 6.5 per 28 days. Patients who had completed either 1 of the monotherapy studies were allowed to participate. In all, 31% of patients received oxcarbazepine as monotherapy throughout the 4-year open-label extension phase, and 69% received the drug as adjunctive therapy. The median dose was 2,343 mg/day, and the median treatment duration was 891days.

Over the course of the study, 55% of patients discontinued therapy, primarily because of seizure control (30%); 12% discontinued because of adverse events, primarily dizziness, headache and fatigue. Five patients developed hyponatraemia during at least 1 visit during the open-label-extension phase.

"We found that the drug works, and works well, with 47% of the patients -- and when you find something that's safe and effective over the long term, that's the key," Dr. Vasquez said.

This study was supported by Novartis.


[Study Title: Safety and Efficacy of Oxcarbazepine After More Than 4 Years Treatment in Patients with Inadequately Controlled Partial Seizures. Abstract 2283]

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