Seroquel Covers Wide Range Of Symptoms In Mania

Main Category: Neurology / Neuroscience
Article Date: 20 Jan 2005 - 11:00 PDT

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New three-month data show fast and sustained efficacy against full range of bipolar mania mood symptoms -

New data published in the Journal of Clinical Psychiatry show Seroquel (quetiapine) monotherapy is effective against all 11 items on the Young Mania Rating Scale, plus aggression and agitation, from within a week and continuing to day 84 compared to placebo [i]. This is the first study to show that Seroquel monotherapy not only has statistically similar efficacy to lithium in symptom improvement over the initial 3-week period, but also maintains symptom improvements with placebo level EPS to a three-month endpoint.

The reduction in agitation and aggression has significant clinical impact as these symptoms are associated with both self-harm and hostility towards others and contribute substantially to the morbidity and mortality that can occur in mania. Other symptoms of bipolar 1 mania interfere significantly with the ability to function normally in both work and social situations and it is important that treatments for mania rapidly improve all symptoms, in order to improve the overall function of these patients.

In the study, quetiapine monotherapy showed significantly greater improvements from baseline in Young Mania Rating Scale compared to placebo as early as day 7, and demonstrated significant improvement on all 11 items on the scale compared to placebo at day 21 and beyond. Secondary endpoints of agitation and aggression were also statistically superior for quetiapine compared to placebo both at day 21 and at day 84, with significant reductions in Positive and Negative Syndrome Scale (PANSS) activation subscale score and supplemental aggression risk scores at both day 21 and day 84.

Dr Richard Bowskill, Consultant Psychiatrist and Deputy Head at the Postgraduate Medical School, Brighton University said,

"These are exciting results, as they show for the first time that Seroquel improves all 11 items on the YMRS both in the short-term, acting quickly, and in the long-term, with improvements lasting for the entire three month period. The fact that aggression and agitation are improved is also significant for healthcare professionals as these can be disturbing and damaging side effects for both the service user and their family."

In the study of 302 patients, quetiapine monotherapy was investigated for a 12-week period versus placebo. The average dose was approximately 600mg/day in responders at day 21 and 84.

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 $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.

-ENDS-

Notes to Editors:

Bipolar mania is part of the mental illness bipolar disorder that is characterized by recurrent swings in mood and energy. Symptoms of bipolar mania typically include feelings of inflated self-esteem or grandiosity, a decreased need for sleep, pressured speech, racing thoughts, distractibility, excessive irritability and reckless behaviour such as spending sprees and sexual promiscuity.

Bipolar disorder is a serious mental illness that affects approximately 3.7% of the adult population. The symptoms are severe and distressing, and can drastically impact upon patients' quality of life, professional lives, and their families and carers.

Seroquel has been licensed for the treatment of schizophrenia since 1997 and is available in 81 countries. Seroquel is also licensed in 35 countries for the treatment of mania associated with bipolar disorder, including the US and several European countries. To date, over 7 million people have been treated with Seroquel worldwide. Seroquel is a trademark of the AstraZeneca group of companies.

Katherine Riedtmann/JoYork
Munro&Forster Communications
Tel: 020 78153975
Tel: 020 7815 3967
katherine.riedtmann@munroforster.com
jo.york@munroforster.com

For further information, please contact:
Beth Birke at AstraZeneca
Tel: +44 (0)1582 836000
beth.birke@astrazeneca.com

References:
[i] Charles L. Bowden, M.D et al. A Randomized, Double-blind, Placebo controlled Efficacy and Safety Study of Quetiapine or Lithium as Monotherapy for Mania in Bipolar Disorder. Journal of Clinical Psychiatry (in press)