Relapse Time Prolonged In Clinically Stable Patients With Bipolar I Disorder Treated With Quetiapine As Adjunct Therapy To Mood Stabilisers

AstraZeneca announced the online publication of long-term SEROQUEL® (quetiapine fumarate) clinical trial data in the Journal of Affective Disorders. Results show that SEROQUEL in combination with lithium or divalproex significantly increased the time to recurrence of any mood event in patients with bipolar I disorder compared with lithium or divalproex alone.1 The study suggests that SEROQUEL, in combination with lithium or divalproex, may lower the risk of a further mood episode when used in the maintenance treatment of patients with bipolar I disorder, irrespective of their index episode (manic, mixed or depressed). SEROQUEL is being reviewed by European regulatory authorities in this indication and is not approved at this time. SEROQUEL was approved in the US for bipolar I maintenance treatment in May 2008 based on data from this study and an identical placebo-controlled double-blind study conducted in the US.


A large-scale, international, randomised, double-blind study (Study 126) investigated the time to recurrence of any mood event (manic, mixed, or depressed) in 1461 patients with bipolar I disorder initially stabilised for at least 12 weeks with open label SEROQUEL (400-800 mg/day) plus lithium or divalproex.1 After stabilisation, 703 patients were randomised to maintenance treatment with SEROQUEL in combination with lithium or divalproex, or placebo in combination with lithium or divalproex for up to 104 weeks. Compared with placebo, fewer patients in the SEROQUEL group had a mood event, defined as a manic, mixed or depressed episode (49.0% vs. 18.5%). SEROQUEL combination treatment significantly reduced the risk of recurrence of a mood event in comparison with placebo plus lithium or divalproex: hazard ratio 0.28; p







The most common adverse events reported during the stabilisation phase were sedation and somnolence (16.3% and 15.3% respectively). The most common adverse events reported post-randomisation in both the SEROQUEL and placebo groups were somnolence (5.7% vs. 2.2%), nasopharyngitis (5.4% in both groups), headache (5.1% vs. 5.7%), and insomnia (3.9% vs. 14.2%). During the stabilisation phase SEROQUEL was associated with a weight gain of 2.9 kg. Post-randomisation SEROQUEL was associated with a weight gain of 0.5 kg compared with a 1.9 kg weight loss with placebo.


The incidence of fasting glucose from normal to greater than or equal to 126 mg/dL in the stabilisation phase was 6.1%, during the post-randomisation phase the incidence was 9.3% in the SEROQUEL group and 4.1% in the placebo group. The SEROQUEL US prescribing information was updated in July 2007 to reflect the increases in blood glucose levels observed in recent trials, with implementation elsewhere consistent with local regulatory requirements. Serious adverse events were seen in 1.5% of the SEROQUEL group compared to 5.4% in the placebo group.


About SEROQUEL and SEROQUEL XR


Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 million* patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the US for the treatment of bipolar depression. In May 2008 the U.S. Food and Drug Administration (FDA) approved SEROQUEL for the maintenance treatment of patients with bipolar I disorder, as adjunct to lithium or divalproex. A submission was recently made seeking similar approval in Europe, in line with previously announced clinical development plans.


SEROQUEL XR™ is approved in the US and 25 further countries for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. It was launched in the US in 2007 and earlier this year AstraZeneca announced the submission of regulatory applications in both the US and European Union for SEROQUEL XR in the treatment of manic episodes associated with bipolar disorder, and the treatment of depressive episodes associated with bipolar disorder. An sNDA for SEROQUEL XR seeking approval for the treatment of Major Depressive Disorder in the US was announced in February 2008 and a similar submission in Europe was announced in June 2008. SEROQUEL XR is not approved for these indications at this time and the applications remain under review by the regulatory authorities.


About AstraZeneca


AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. astrazeneca


*Based on assumptions: (1) estimated number of prescriptions per patient based upon IMS APLD data; and (2) IMS Prescription data for SEROQUEL covering 13 major markets in which this data is available since the time of launch.


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

References


1. Vieta E et al. Efficacy and safety of quetiapine in combination with lithium/divalproex for maintenance of patients with bipolar I disorder (international trial 126) Journal of Affective Disorders 2008;3: 251-263


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