h3. Seroquel XR (quetiapine) Approved for Maintenance Treatment to Prevent Recurrence of Bipolar Disorder
AstraZeneca announced that once-daily Seroquel XR (extended-release tablets) has been approved in Ireland for the prevention of recurrence of bipolar disorder (BD) in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.
Following this new indication, quetiapine is the only agent approved in the European Union to treat all phases of bipolar disorder – acute depressive episodes, acute manic episodes and maintenance treatment to prevent recurrence of any mood event in bipolar disorder. The mechanism of action of quetiapine involves both antipsychotic and antidepressant activities, which may help explain its efficacy across the spectrum of mood episodes associated with bipolar disorder.
Bipolar disorder is a lifelong psychiatric condition that affects 3-5% of adults worldwide. Although many BD patients achieve remission after treatment of an acute episode, bipolar disorder is a chronic illness and patients remain at risk of experiencing a recurrence. As a result, long-term maintenance treatment to prevent recurrence is a vital part of managing the condition.
The authorisation was based on one long-term study (1,2) (up to 2 years treatment) evaluating recurrence prevention in patients with manic, depressed or mixed mood episodes.
Patients were treated for an acute manic, mixed or depressed episode and stabilised for at least 4 consecutive weeks on quetiapine, then randomised to continue quetiapine (300-800mg/day) or switched to either lithium (target serum 0.6-1.2mEq/L) or placebo for up to 104 weeks or until a recurrent mood event. The primary endpoint was time to recurrence of any mood event.
Time to recurrence of a mood event longer with quetiapine
Time to recurrence of any mood event was significantly longer in patients continuing with quetiapine versus switching to placebo (p<0.0001), in patients switching to lithium versus placebo (p<0.0001), and in patients continuing quetiapine versus switching to lithium (p=0.005).
Less patients experienced a mood event with quetiapine
A total of 22.5% experienced a mood event in the quetiapine group, compared to 51.5% in the placebo group and 26.1% in the lithium treatment group. In patients who responded to quetiapine, the results indicated that a switch to lithium treatment does not appear to be associated with an increased time to recurrence of a mood event compared to continued treatment with quetiapine.
The study was terminated when interim analysis provided positive results.
About Bipolar Disorder
Bipolar disorder is a chronic, lifelong psychiatric condition that causes dramatic and severe mood swings.
It is estimated that the worldwide prevalence of bipolar disorder is 3-5% (about 222 million adults).
Up to half of all individuals with bipolar disorder make at least one suicide attempt in their lifetime, and approximately 10-15 percent complete suicide.
BD I vs. BD II
Bipolar I disorder is the classic form of the disease, characterised by recurrent episodes of mania and depression. Bipolar II disorder involves one or more episodes of major depression with at least one episode of mild to moderate mania (hypomania), but never full mania.
Bipolar disorder is often misdiagnosed as unipolar depression. This misdiagnosis can lead to treatment that may exacerbate the disease. In fact, many patients face up to ten years without appropriate treatment before a correct diagnosis is made.
Bipolar disorder is typically managed through a treatment strategy with several phases – including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.
These results demonstrate that quetiapine is an effective treatment that reduces the long-term risk of recurrence of manic, mixed or depressive episodes in bipolar disorder.
“This new authorisation for Seroquel XR provides patients with the important new option of a single agent for the treatment of bipolar disorder”, said Hans Eriksson, MD, Medical Science Director for AstraZeneca.
1- Nolen W., et al. ECP Poster 2009 Quetiapine or lithium versus placebo for maintenance treatment of bipolar I disorder after stabilization on quetiapine (Trial D1447C00144)
2- AstraZeneca data on file DoF-Seroquel-9047
Full prescribing information available on www.medecines.ie and references available from AstraZeneca Pharmaceuticals (Ireland) Ltd. Telephone: (01) 6097100.
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