News Release

SEROQUEL: An effective treatment option for aggression in patients with schizophrenia

Study shows SEROQUEL's efficacy in reducing aggression and violent behaviour in patients with psychotic schizophrenia symptoms

Peer-Reviewed Publication

Shire Health International

Alderley Park, UK, 17 June 2005 – A new study, published today in the journal Human Psychopharmacology: Clinical and Experimental,1 shows that the atypical antipsychotic SEROQUEL (quetiapine), may be an effective treatment option for patients with schizophrenia who exhibit aggressive behaviour during psychotic episodes. In the study, patients who received SEROQUEL demonstrated significantly greater improvements in symptoms of aggression and hostility compared to patients receiving placebo (p<0.01 P<0.01 on Brief Psychiatric Rating Scale (BPRS) alternative hostility cluster score, one of three parameters derived from the BPRS to measure hostility symptoms in the study. ).

"Aggressive behaviour is a significant problem in patients with schizophrenia and has severe negative consequences for the patient, families, carers and the therapeutic community as a whole" commented Professor Celso Arango, from the Hospital General Universitario Gregorio Maranon, Madrid, Spain, and study author. "It is important that patients who are experiencing aggressive symptoms are prescribed a therapy which not only treats these symptoms but which they also find acceptable, in terms of its tolerability, so that they adhere to the prescribed treatment" continued Professor Arango. "In both respects, SEROQUEL holds advantages for both patient and clinician, making it a powerful treatment option for these distressing and challenging symptoms."

SEROQUEL has been shown to provide first line efficacy together with trusted tolerability in treatment of schizophrenia during three randomised, double-blind, placebo-controlled studies.2, 3, 4 The study published today, an analysis of pooled data from these three pivotal trials, included a total of 389 patients who exhibited aggressive behaviour at study entry. The results show that patients who received SEROQUEL demonstrated significantly greater improvements in symptoms of aggression and hostility, compared with patients taking placebo, across all three efficacy parameters used in the study.** In addition, the analysis showed that these improvements in hostility were highly correlated with improvements seen in patients' positive symptoms (characterised by delusions, an inability to think clearly and hallucinations).1

Although the vast majority of patients with schizophrenia are not violent, much of the stigma associated with the condition is linked to the public perception that patients are inherently violent or aggressive. Historically, first generation antipsychotics have been the mainstay of treatment for treating aggressive or violent patients, however severe side effects limit their benefit.1 Therefore, research in this field, particularly as regards the benefits of newer atypical antipsychotics such as SEROQUEL in reducing such violent behaviour, is of great importance to patients and their families.

SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 82 countries for the treatment of this condition. SEROQUEL is also licensed in 63 countries for the treatment of mania associated with bipolar disorder, including the US, Canada and several European countries. To date, over 8 million people have been treated with SEROQUEL worldwide.

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Notes to editors:
** Study efficacy assessment methodology: Hostility and aggression were assessed on three parameters derived from the brief psychiatric rating scale (BPRS):

  • hostility item scores
  • alternative hostility cluster (sum of the items anxiety, tension, hostility, uncooperativeness and excitement)
  • alternative Factor V (sum of the items of hostility and uncooperativeness).
Only patients who were symptomatic on a given parameter at baseline were included in the analysis. The BPRS positive symptom cluster score was used to measure change in positive symptoms in all patients who had data available for at least one of the aggression parameters.

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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL and ZOMIG. SEROQUEL, which has proven efficacy and a very favourable side effect profile, is the fastest growing of the leading atypical antipsychotics and the number one prescribed atypical in the United States with global sales of $2 billion in 2004; ZOMIG is a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia, stroke, pain control and anaesthesia.

SEROQUEL is a trademark of the AstraZeneca group of companies. All product names appear in capitals.

For more information, please visit www.astrazenecapressoffice.com or please contact:

References:
1. Arango C, Bernardo M. The effect of quetiapine on aggression and hostility in patients with schizophrenia. Hum Psychopharmacol Clin Exp 2005; 20, 4: 237-241
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2. Arvanitis LA, Miler BG, et al. Multiple fixed doses of Seroquel (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. Biol Psychiatry 1997; 42: 233-503
3. Borrison RL, Arvanitis LA, et al. ICI 204,636, an atypical antipsychotic: efficacy and safety in a multicenter, placebo-controlled trial in patients with schizophrenia. J Clin Psychopharmacol 1996; 16: 158-169
4. Small JG, Hirsch SR, et al. Quetiapine in patients with schizophrenia: a high and low-dose double-blind comparison with placebo. Arch Gen Psychiatry 54: 549-557


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