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New Study Shows Lamotrigine Effective For Maintenance Treatment of Bipolar I Disorder

RESEARCH TRIANGLE PARK, N.C., April 14 /PRNewswire/ -- Results of a landmark study published in the April issue of Archives of General Psychiatry show that Lamictal® (lamotrigine), was effective in delaying the relapse/recurrence of any mood episode in bipolar I patients who had recently experienced and been treated for an acute manic or hypomanic episode. The study results, from one of the longest and largest trials ever conducted in bipolar disorder, point to the therapeutic effects of Lamictal in the maintenance treatment of bipolar I disorder.

This 18-month study assessed the safety and efficacy of Lamictal and lithium compared to placebo in delaying the relapse/recurrence of any mood episode (depression, mania, hypomania, mixed states) in adult patients (18 and older) with bipolar I disorder. Of 349 patients who met screening criteria and entered the open-label phase, 175 met stabilization criteria and were randomized to double blind maintenance treatment. Lamictal was superior to placebo at prolonging the time to intervention for any mood episode. The most commonly reported side effects during the double-blind phase of this study were headache, infection, influenza, somnolence, insomnia, nausea, diarrhea and rash.

"These groundbreaking results indicate that Lamictal is a significant advance in the treatment of bipolar disorder," said Charles Bowden, M.D., chairman of the Department of Psychiatry, University of Texas Health Science Center, and lead author of this study. "Bipolar disorder historically has been difficult to treat. New treatments approved within the last 25 years for use in bipolar disorder are only indicated for mania."

Joseph R. Calabrese, M.D., director of the Mood Disorders Center at the University Hospitals of Cleveland and professor of psychiatry at the Case Western University School of Medicine, who was also a study author, said, "Bipolar studies conducted over the past 25 years have almost always focused on the short-term treatment of bipolar mania, but these data suggest that Lamictal is a mood stabilizer with long-term efficacy in bipolar depression."

About Lamictal

Lamictal is available in over 90 countries and has been used by an estimated 5 million patients worldwide.

Lamictal has been available in the U.S. since 1994 and currently is indicated as adjunctive therapy for partial seizures in adults and pediatric patients (greater than or equal to 2 years of age). Lamictal is also indicated as adjunctive therapy for the generalized seizures of Lennox-Gastaut syndrome in adult and pediatric patients (greater than or equal to 2 years of age). Lamictal is indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug.

The safety and effectiveness of Lamictal have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from non-enzyme-inducing anti epileptic drugs (e.g. valproate), or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs). Safety and effectiveness in patients below the age of 16 other than those with partial seizures and the generalized seizures of Lennox-Gastaut syndrome have not been established.

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal. The incidence of these rashes, which have included Stevens-Johnson Syndrome, is approximately 0.8% (8/1,000) in pediatric patients under the age of 16 years receiving Lamictal as adjunctive therapy, and 0.3 percent (3/1,000) in adults. In a prospectively followed cohort of 1,983 pediatric patients taking adjunctive Lamictal, there was one rash-related death. In worldwide post-marketing experience, rare cases of toxic epidermal necrolysis (TEN) and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate. Lamictal ordinarily should be discontinued at the first signs of rash, unless the rash is clearly not drug-related.

The risk of nonserious rash is increased when the recommended initial dose and/or the rate of dose escalation of Lamictal is exceeded. There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by 1) coadministration of Lamictal with valproic acid; 2) exceeding the recommended initial dose of Lamictal; or 3) exceeding the recommended dose escalation of Lamictal. However, cases have been reported in the absence of these factors. Therefore, it is important that the dosing recommendations be followed closely. For more information on Lamictal, log on to http://www.lamictal.com/.

GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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