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Title: Conversion to Extended-Release Divalproex (divalproex sodium) Might Address Some Safety, Efficacy Problems: Presented at AES

"Conversion to Extended-Release Divalproex (divalproex sodium) Might Address Some Safety, Efficacy Problems: Presented at AES"

By Bonnie Darves BOSTON, MA -- December 15, 2003 -- Using a once-daily dose of extended-release divalproex sodium (Depakote) might reduce side effects commonly seen with this antiepileptic drug while improving patient compliance, according to a study presented here December 9th at the American Epilepsy Society Annual Meeting. Concerns about the drug's safety, which is also used for migraine treatment, have been raised by published reports of liver toxicity and rare but life-threatening pancreatitis. Another common, though far less serious, side effect of divalproex is tremor. Switching to the extended-release formulation may ameliorate such safety risks while improving efficacy, reported researchers from Rush Epilepsy Center, Chicago, University of Cincinnati, Ohio, United States, and from Abbott Laboratories. "What is being reported anecdotally is being confirmed in the literature -- that patients who are experiencing side effects from [traditional-formulation] Depakote do better on the extended-release form -- in both efficacy and safety," said Michelle Collins, PhD, a senior research scientist with Abbott Laboratories. In the study, researchers conducted a meta-analysis of five clinical trials involving a total of 213 patients. Prior to conversion from the delayed-release to the extended-release formulation, the average dose was 1,620 mg daily; after conversion, the average dose of extended-release divalproex was 1,800 mg daily. The researchers found that of the 61% of patients who reported adverse events while on delayed-release divalproex, 83% reported improvement after the conversion. In particular, 39 patients who experienced tremor with the delayed-release formulation reported significant improvement after the conversion. Lead author Michael C. Smith, MD, noted that although larger studies with more prolonged follow-up periods are needed to confirm these findings, this analysis shows that extended-release divalproex sodium is much better tolerated than the delayed-release formulation and still provides good seizure control. Dr. Smith noted that use of the extended-release formulation enables titration to maximum effective dose while possibly reducing the risk of peak-concentration related side effects. The study was supported by Abbott Laboratories. [Study title: Improved Tolerability and Efficacy With the Extended-Release Formulation of Divalproex Sodium, Results of a Meta-Analysis. Abstract 2.280]

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