Public Release: 

New data shows Seroquel achieves remission in bipolar mania

Shire Health International

Alderley Park, England — May 7, 2004 — AstraZeneca announced important new data today that show patients with bipolar disorder who were treated with SEROQUEL (quetiapine) were significantly more likely to achieve full remission of their mania symptoms compared to patients who received placebo.1 The data were presented at the 157th American Psychiatric Association (APA) congress.

After 3 weeks of treatment with SEROQUEL monotherapy (median dose of 600mg/day), 36% of patients had achieved remission from their symptoms compared to 21.5% of patients treated with placebo (p<0.01). The results also indicated that remission rates for patients on SEROQUEL increased during the treatment period with 61% of patients achieving remission after 12 weeks (p<0.001).1

"Patients with bipolar disorder want to live a normal life without manic symptoms such as racing thoughts, reckless behaviour and decreased sleep, since many are highly functioning individuals. These results suggest that treatment with quetiapine contributes to remission of these debilitating symptoms," commented Dr Eduard Vieta, Director of Research, Department of Psychiatry, University of Barcelona. "The implications of this study are of great importance for patients wanting the most effective treatment for their illness, especially as several clinical studies have confirmed quetiapine's efficacy in the treatment of bipolar mania," he continued.

Clinical remission is generally defined as the patient attaining a YMRS* total score of ≥ 12. These results were based on analyses using the more stringent assessment criteria of a YMRS ≥ 12 plus MADRS** score of ≥ 10, and a YMRS ≥ 12 plus MADRS score ≥ 8 A separate analysis also focused on the proportion of patients who achieved euthymia which was defined in the study using two different sets of criteria. The first used a more stringent definition of a YMRS score of ≥ 12 and MADRS score ≥ 8. A second assessment used a euthymia definition of YMRS score ≥ 12 and MADRS score ≥ 10.

The results showed:

  • At 3 weeks, remission rates for SEROQUEL vs placebo were:
    - 37.5% vs 23.1% with YMRS ≥ 12 assessment criteria (p<0.01)
  • At 3 weeks, euthymia rates for SEROQUEL vs placebo were: - 35.6% vs 21.5% with YMRS ≥ 12 plus MADRS score of ≥ 10 assessment criteria (p<0.01)
    - 35.1% vs 20.0% with YMRS ≥ 12 plus MADRS score ≥ 8 assessment criteria (p<0.01)
  • At 12 weeks, remission rates for SEROQUEL vs placebo were:
    - 65.4% vs 35.9% with YMRS ≥ 12 assessment criteria (p<0.001)
  • At 12 weeks, euthymia rates for SEROQUEL vs placebo were:
    - 60.1% vs 30.8% with YMRS ≥ 12 plus MADRS score of ≥ 10 assessment criteria (p<0.001)
    - 58.7% vs 29.7% with YMRS ≥ 12 plus MADRS score ≥ 8 assessment criteria (p<0.001)

    The data were taken from a pooled analysis of two 12-week randomised, double-blind studies involving hospitalised patients with bipolar I disorder. Patients received SEROQUEL (average doses in responders 575mg/day at day 21 and 598mg/day at day 84) or placebo.

    These results are also supported by other data presented at APA today, which analysed remission and euthymia rates among patients treated with SEROQUEL in combination with lithium or divalproex versus those treated with lithium or divalproex alone.2 Significantly more patients on SEROQUEL achieved euthymia compared to patients on lithium or divalproex alone (38.4% vs 25.9% respectively, p = 0.014).2

    Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world.3,4,5,6 More than half of those with bipolar disorder stop taking their medication at some point during their illness, subjecting themselves to a high risk of relapse and an increased risk of suicide.7 A medication's overall efficacy and tolerability profile is therefore vital to helping patients comply with their medications.

    SEROQUEL is licensed in Europe and the US for the treatment of mania associated with bipolar disorder. Licences for bipolar mania have also been received in other countries. SEROQUEL has been licensed for the treatment of schizophrenia since 1997.

    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 top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) 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, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG, 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 and stroke, pain control and anaesthesia.

    For more information, please visit www.astrazenecapressoffice.com

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    Notes to Editors:
    All product names appear in upper case. SEROQUEL is a trade mark of the AstraZeneca group of companies.

    Euthymia = absence of mood elevation or depression.
    For further information, please contact:

    Carla Burigatto at AstraZeneca
    Tel: 302-886-5953
    carla.burigatto@astrazeneca.com
    or
    Rebecca Moan at Shire Health International
    Tel: 212-329-6270
    rebecca.moan@shirehealthinternational.com

    For an electronic and downloadable version of this press release or for further information about SEROQUEL, please visit the psychiatry resource internet site at: www.psychiatry-in-practice.com. This psychiatry resource features educational materials relating to severe mental illness, including background information on schizophrenia as well as epidemiological data and treatment issues clinicians face in everyday practice.

    References:
    1 Paulsson, B & Jones, M. Sustained remission/euthymia with quetiapine monotherapy for bipolar mania. Abstract presented at APA 2004, NYC, USA.
    2 Sussman, N., Mullen, J., Sweitzer, DE. Mania remission rates and euthymia with quetiapine combination therapy. Abstract presented at APA 2004, NYC, USA.
    3 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385;395.
    4 Hirschfield et al. Screening for bipolar disorder in the community J Clin Psychiatry. 2003:64;53-59
    5Lisd JD, Dime-Meenan S, Whybrow PC et al. The National Depressive and Manic-Depressive Association (DMDA) survey of bipolar members. J Affect Disord. 1994:31;281-294.
    6 World Health Organization and the World Bank. The Global Burden of Disease: Summary. Cambridge, Mass: The Harvard School of Public Health Harvard University Press, 1996.
    7 Miklowitz D. The Bipolar Disorder Survival Guide. New York: The Guildford Press, 2002.

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