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      Women Gain Weight with Valproate, But Not with Lamotrigine: Presented at ACOG

      By Bruce Sylvester

      NEW ORLEANS, LA -- May 6, 2003 -- Weight and body mass index (BMI) remain stable in women using the antiepileptic lamotrigine and increase significantly in women on valproate, researchers reported here on April 30th in a poster session at the 51st Annual Meeting of the American College of Obstetrics and Gynecology.

      "We saw significant mean weight gain in the valproate cohort of this study within 10 weeks of initiation of therapy," said investigator and presenter James Miller, DPhar, a researcher in the Epilepsy Development Group, GlaxoSmithKline, in Research Triangle Park, North Carolina. "On the other hand we saw comparable efficacy of lamotrigine treatment without this adverse side effect, suggesting that lamotrigine would be used more readily and consistently among this population and with less risk of developing diabetes."

      The investigators enrolled 75 women in this prospective, randomised, double-blind comparator trial. If these, 28 of 38 randomised to lamotrigine completed the treatment and 19 of 37 randomised to valproate completed treatment. The mean age of the women was 31.1 in the lamotrigine group and 29.1 in the valproate group.

      Mean maintenance dose of lamotrigine was 249 mg/day and 1637 mg/day for valproate. Mean baseline weight was 62 kg in the lamotrigine group and 70 kg in the valproate group.

      At end point, the researchers observed a mean BMI increase of 0.07 in the women treated with lamotrigine and an increase of 2.37 in those treated with valproate (P<0.001)

      Efficacy was comparable for both groups, at 32% for lamotrigine and 35% for valproate, said Dr. Miller.

      "The incidence of tremor, somnolence, nausea, appetite increase, hair loss, weight increase and vomiting tended to be higher in the valproate group," the investigators noted, "whereas the incidence of headache, asthenia, and abdominal pain tended to be higher in the lamotrigine treatment group."

      GlaxoSmithKline supported the research.


      [Study title: Weight Gain Associated with Valproate Versus Lamotrigine Monotherapy in Women.]



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