New Analysis Highlights Potential Of SEROQUEL For Long-term Treatment Of Bipolar Disorder

Main Category: Bipolar
Article Date: 28 Jan 2008 - 11:00 PDT

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Results from a new analysis of two major clinical trials have shown that patients with bipolar disorder who received long-term treatment with SEROQUEL (quetiapine fumarate) plus a mood stabiliser were significantly less likely to have a mood event (manic, mixed or depressed) than patients on a mood stabiliser alone.1 The data, which highlight the potential of SEROQUEL for maintenance therapy of patients with bipolar I disorder, were presented on Sunday, 27 January 2008 at the 3rd Biennial Conference of the International Society for Bipolar Disorders (ISBD) in Delhi, India.

The new analysis1 was based on pooled results from two large-scale, international, double-blind studies (studies 126 and 127)2,3 that investigated the time to recurrence of a mood event in patients with bipolar I disorder. After achieving 12 weeks of clinical stability, 1334 patients were randomised to maintenance treatment with SEROQUEL (400-800 mg/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.

"Bipolar disorder is a chronic, lifelong illness and patients suffer frequent relapses when they can become depressed or manic. Maintenance therapy is an important part of managing these patients and can offer long-term relief from these recurrences," said Professor Eduard Vieta, Clinical Institute of Neuroscience, University of Barcelona, Spain. "Our analysis of data from more than a thousand patients suggest the potential of treatment regimens which include SEROQUEL along with a mood stabiliser to reduce the likelihood of mood events."

Long-term treatment with SEROQUEL was generally well tolerated - the most commonly reported adverse events in patients treated with SEROQUEL plus a mood stabiliser during the randomised treatment phase were headache (7.4%), nasopharyngitis (7.1%) and upper respiratory tract infection (6.7%). The most common adverse events during the open-label stabilisation phase were sedation (23.8%), somnolence (18.7%), dry mouth (16.5%) and weight increase (13.9%). The analysis also showed a greater incidence of fasting blood glucose increases to hyperglycaemic levels (≥126 mg/dL [7 mmol/L]) in patients randomised to SEROQUEL plus mood stabiliser (10.7%, 18.0 patients per 100 patient-years) than in patients randomised to placebo and mood stabiliser (4.6%, 9.5 patients per 100 patient-years). SEROQUEL prescribing information is being updated based on local regulatory requirements to include additional details regarding these data. At this time, SEROQUEL is not yet approved for bipolar maintenance treatment. However, a submission was made to the FDA in July 2007.

Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 25 million* patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression. Once daily SEROQUEL® XR (quetiapine fumarate extended release tablets) was launched for the treatment of schizophrenia in the US in 2007, and its clinical development program and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalised anxiety disorder (GAD).

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

SEROQUEL XR is a trademark of the AstraZeneca group of companies.

References

1. Brecher M, et al. Quetiapine in the maintenance treatment of bipolar I disorder: combined data from two long-term phase III studies. Presented at the Conference of the International Society for Bipolar Disorders, Delhi, India, 27-30 January, 2008.

2. Vieta E, et al. Efficacy and safety of quetiapine in combination with lithium/divalproex as maintenance treatment for bipolar I disorder. Presented at the Conference of the International Society for Bipolar Disorders, Delhi, India, 27-30 January, 2008.

3. Suppes T, et al. Maintenance treatment in bipolar I disorder with quetiapine concomitant with lithium or divalproex: a placebo-controlled, randomized multicenter trial. Presented at the Conference of the International Society for Bipolar Disorders, Delhi, India, 27-30 January, 2008.

* This estimate is based upon: (1) assumptions as to persistence (the number of prescriptions per patient) based upon 2002 market research; and (2) projections of prescriptions since launch based upon information available in the US and 13 of the 50 other countries in which SEROQUEL is marketed.

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