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-- TEAEs were mild to moderate and appeared to be dose-related.
-- The incidence of weight gain and other troublesome TEAEs such as
somnolence and cognitive and psychiatric AEs appeared low:
-- The incidence of somnolence was 7 percent for the Vimpat(R)-treated
group vs. 5 percent for placebo
-- The incidence of memory impairment was 2 percent for both Vimpat(R)
and placebo groups
-- The incidence of depression was 2 percent for the Vimpat(R)-treated
group and 1 percent for placebo
-- The incidence of weight gain was 1 percent for both Vimpat(R) and
placebo groups
Poster Session 3, December 8, 2008, 11:30 am - 12:30 pm (Poster 3.245)
V. Biton, N. Fountain, F. Rosenow, A. Gil-Nagel, T. Sullivan, D. Hebert, P. Doty
Clinical Trials, Inc., Little Rock, Arkansas;
Important safety information about Vimpat(R) in the U.S.
Vimpat(R) tablets are indicated as adjunctive therapy in the treatment of
partial-onset seizures in patients with epilepsy who are 17 years and older.
Vimpat(R) injection is indicated as short-term replacement when oral
administration is not feasible in these patients. Patients should be advised
that Vimpat(R) may cause dizziness, ataxia, and syncope. Caution is advised
for patients with known cardiac conduction problems, who are taking drugs
known to induce PR interval prolongation, or with severe cardiac disease. In
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