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Considered one of the most severe forms of mental illness, bipolardisorder currently affects about 8 million adults in the U.S.(3-5) Bipolar Idisorder is a lifelong psychiatric condition characterized by manic or mixedmood episodes, interspersed with major depressive episodes. (6) It isestimated that 0.4 percent to 1.6 percent of individuals will develop bipolarI disorder in their lifetime. (6)
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"This new indication for SEROQUEL marks an important milestone in thetreatment of bipolar I disorder because it provides patients with anotheroption over the long-term. In fact, despite the number of currently availabletreatments, many patients with bipolar I disorder do not receive effectivetherapy and some 20 to 30 percent of patients continue to display residualmood symptoms of bipolar I disorder," said Mark Scott, Executive Director,Clinical Development, SEROQUEL. "The studies showed that SEROQUEL, withlithium or divalproex, can provide clinicians with a safe and effectivelong-term treatment option that reduced the risk of relapse of both manic anddepressive mood events in bipolar I disorder."
The FDA approval was based on two multicenter, randomized, double-blind,placebo-controlled clinical trials that evaluated SEROQUEL when used as anadjunct therapy to lithium or divalproex in the maintenance treatment of adultpatients with bipolar I disorder (n=703, n=623 respectively). (7,8) Therigorous study design included a 12 to 36 week stabilization phase which wasfollowed by a longer-term, randomized, double-blind treatment phase that had amean duration of exposure of 213.2 days for SEROQUEL and 152.4 days forplacebo. (9)
In both studies, patients with bipolar I disorder whose most recentepisode was manic, depressed, or mixed, were treated with either SEROQUEL(flexible dosing between 400 and 800 mg per day in divided doses) pluslithium-or-divalproex or placebo plus lithium-or-divalproex. (9) The primaryendpoint, which was time to recurrence of a depressive, manic, or mixed moodevent, was significant for SEROQUEL compared with placebo in both studies. (9)Pooled study results indicated that patients treated with SEROQUEL pluslithium-or-divalproex (n=646) had a risk reduction of 70% relative to thosetreated with placebo plus lithium-or-divalproex (n=680) for time to recurrenceof a mood event (HR: 0.30; 95% CI: 0.24, 0.37; p<0.001). (9) This reductionin 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 whorelapsed 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 theopen-label stabilization phase and the randomized controlled-phase, weregenerally consistent with those reported in short term, placebo-controlledtrials for SEROQUEL. In the pooled data of the two clinical studies, agreater incidence of blood glucose increases to hyperglycemic levels(Greater Than or Equal to 126mg/dL) was observed in patients randomized toSEROQUEL plus lithium-or-divalproex than in patients randomized to placeboplus lithium-or-divalproex. The SEROQUEL prescribing information was updatedin July 2007 to reflect the increases in blood glucose levels observed inthes
