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FDA Approves AstraZeneca's Seroquel(R) for Maintenance Treatment in Bipolar Disorder
Date:5/14/2008

,8) The rigorous study design included a 12 to 36 week stabilization phase which was followed by a longer-term, randomized, double-blind treatment phase that had a mean duration of exposure of 213.2 days for SEROQUEL and 152.4 days for placebo. (9)

In both studies, patients with bipolar I disorder whose most recent episode was manic, depressed, or mixed, were treated with either SEROQUEL (flexible dosing between 400 and 800 mg per day in divided doses) plus lithium-or-divalproex or placebo plus lithium-or-divalproex. (9) The primary endpoint, which was time to recurrence of a depressive, manic, or mixed mood event, was significant for SEROQUEL compared with placebo in both studies. (9) Pooled study results indicated that patients treated with SEROQUEL plus lithium-or-divalproex (n=646) had a risk reduction of 70% relative to those treated with placebo plus lithium-or-divalproex (n=680) for time to recurrence of a mood event (HR: 0.30; 95% CI: 0.24, 0.37; p<0.001). (9) This reduction in risk was significant for both recurrence of manic episodes (HR: 0.30; 95% CI: 0.22, 0.41; p less than 0.001) and recurrence of depressive episodes (HR: 0.30; 95% CI: 0.23, 0.40; p less than 0.001). The proportion of patients who relapsed when treated with SEROQUEL was 19.3% [125/646] versus 50.4% [343/680] of patients on placebo. (9)

Adverse events in these trials, which were monitored during both the open-label stabilization phase and the randomized controlled-phase, were generally consistent with those reported in short term, placebo-controlled trials for SEROQUEL. In the pooled data of the two clinical studies, a greater incidence of blood glucose increases to hyperglycemic levels (Greater Than or Equal to 126mg/dL) was observed in patients randomized to SEROQUEL plus lithium-or-divalproex than in patients randomized to placebo plus lithium-or-divalproex. The SEROQUEL prescribing information was updated in July 2007 to reflect the increases in blood glucose levels obs
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SOURCE AstraZeneca
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