Results from a new analysis of two major clinical trials have shown that patients with bipolar disorder who received long-term treatment with Anglo-Swedish drug major AstraZeneca's Seroquel (quetiapine fumarate) plus a mood stabilizer were significantly less likely to have a mood event (manic, mixed or depressed) than patients on a mood stabilizer alone, according to data presented at the Biennial Conference of the International Society for Bipolar Disorders, held in Delhi, India.
The new analysis was based on pooled results from two large-scale, international, double-blind studies that investigated the time to recurrence of a mood event in patients with bipolar I disorder. After achieving 12 weeks of clinical stability, 1,334 patients were randomized to maintenance treatment with Seroquel (400-800mg/day) plus lithium or divalproex, or placebo in combination with lithium or divalproex for up to 104 weeks.
Seroquel combination treatment produced a significant 70% reduction in the risk of recurrence of a mood event compared with placebo plus lithium or divalproex (hazard ratio 0.30; p<0.001), and fewer patients in the Seroquel group had a mood event (19.3% versus 50.4% in the placebo group). The reduction in risk of event recurrence was similar for both manic and depressed events, AstraZeneca noted.
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