New Analysis Demonstrates Efficacy Of Seroquel (Quetiapine Fumarate) Maintenance Treatment For Bipolar I Disorder

Main Category: Bipolar
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Jan 2008 - 16:00 PDT

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Results from a combined analysis of two long term phase III clinical trials2,3 have shown that patients with bipolar I disorder who received treatment with quetiapine plus a mood stabiliser showed a 70% reduction in the risk of recurrence of a mood event (manic, mixed or depressed) compared to patients on a mood stabiliser alone (HR=0.30, P<0.001).1 The data, which demonstrates the efficacy of quetiapine for maintenance therapy of patients with bipolar I disorder, was presented at the 3rd Biennial Conference of the International Society for Bipolar Disorders (ISBD) in Agra, India, 30 January 2008. Quetiapine is not licensed for bipolar depression or maintenance treatment in the UK.

"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."

Currently quetiapine is licensed in the UK for the treatment of patients with manic episodes associated with bipolar disorder and for the treatment of schizophrenia and is not licensed for bipolar depression or maintenance treatment in the UK.

Study analysis

The combined 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 clinical stability for a minimum of at least 12 weeks, 1,334 patients were randomised to maintenance treatment with Seroquel (quetiapine fumarate) (400-800 mg/day) plus lithium or divalproex, or placebo in combination with lithium or divalproex for up to 104 weeks. Quetiapine 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 quetiapine and mood stabiliser 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.

Long-term treatment with quetiapine and mood stabiliser was generally well tolerated, the most commonly reported adverse events in patients treated with quetiapine 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 greater incidence in a single emergent a fasting blood glucose value ≥126 mg/dL [7 mmol/L]) in patients randomised to quetiapine 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

Launched in 1997, it is estimated that quetiapine has been prescribed to more than 25 million* patients worldwide. Quetiapine 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.

AstraZeneca

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.

* 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.

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 3rd Biennial Conference of the International Society for Bipolar Disorders, Agra, India, 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 3rd Biennial Conference of the International Society for Bipolar Disorders, Agra, India, 30 January 2008.

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

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