Once-Daily SEROQUEL XL(R) Prevents Relapse In Patients With Schizophrenia Clear Long-term Benefit Leads To Early Completion Of Study

Main Category: Schizophrenia
Article Date: 24 Nov 2007 - 0:00 PDT

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A new study, published in the November 2007 issue of Psychiatry 20071 found that the once daily formulation of SEROQUEL XL® in adult patients with schizophrenia significantly reduces the risk of psychotic relapse. The study was scheduled to last one year or until relapse, but significant differences in the relapse rate between active treatment and placebo required the study to be stopped early. Seroquel XL is currently not licensed in the UK and is known as Seroquel XR"! in the rest of the world.

Schizophrenia patients experience high rates of symptom relapse, and as a result, there is an important need for options for long-term treatment of schizophrenia.1,2,3

The randomised, double-blind study examined the time to first psychiatric relapse in 197 patients with clinically stable schizophrenia treated with either Seroquel XL (mean daily dose 669 mg/day) or placebo. As the study was terminated after a positive interim analysis the mean duration of the randomised phase was four months (120 days) and the maximum period was nine months (270 days).

In the interim analysis population, active treatment significantly increased the time to relapse (hazard ratio 0.16; p<0.0001) and significantly reduced the risk of relapse by 84% (p<0.0001) compared with placebo. Only 9 (10.7%) patients in the active treatment group experienced a relapse during the study compared with 36 (41.4%) patients in the placebo group, and 90% of Seroquel XL recipients remained relapse free for 2.9 months.

In addition to providing protection from relapse, Seroquel XL also significantly improved schizophrenia symptom scores on the Positive and Negative Syndrome Scale (PANSS) (47.15 vs. 48.86 for the placebo group at the last visit; p<0.01). Significant benefits were also seen in the Clinical Global Impression (CGI) scales for improvement and severity (p<0.001). No patients treated with Seroquel XL required hospitalisation due to worsening schizophrenia compared with 8.3% of placebo recipients.

References:

1. Peuskens J, Trivedi J, Malyarov S, Brecher M, Svensson O, Miller F, Persson I & Meulien D on behalf of the study D1444C00004 Investigators. Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients. Psychiatry 2007. In press.

2. Kane JM. "Drug Therapy: Schizophrenia." N Engl J Med. 1996; 334 (1): 34-41.

3. Robinson D et al. "Predictors of Relapse Following Response From a First Episode of Schizophrenia or Schizoaffective Disorder." Arch Gen Psychiatry. 1999; 56: 241-247.

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Note:

In the rest of the world Seroquel XL ® is known as Seroquel XL"!. In Seroquel XL is a trademark of the Astrazeneca group of companies.

About Seroquel

The U. S. Food and Drug Administration (FDA) approved Seroquel XL, known as XR in the US, in May 2007 for the treatment of schizophrenia in adult patients. The Netherlands regulatory authority Medicines Evaluation Board (MEB) has also approved Seroquel XL, and AstraZeneca has applied for a Mutual Recognition Procedure to seek similar approvals across Europe. AstraZeneca has filed for approval to the UK's MHRA under a national licence.

Launched in 1997, Seroquel (quetiapine fumarate, immediate release) is licensed in 85 countries for the treatment of schizophrenia, in 73 countries for the treatment of mania associated with bipolar disorder, and in October 2006 it was approved in the US by the FDA for the treatment of bipolar depression.

About 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.

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