News Release

New bipolar survey: Patients' satisfaction influenced

Additional data presented at the World Congress on Biological Psychiatry suggest the bipolar disorder treatment Seroquel provides positive efficacy benefits

Peer-Reviewed Publication

Shire Health International

Vienna, June 29th 2005 – Preliminary results from a large-scale global study of people living with bipolar disorder,1 presented today at the World Congress of Biological Psychiatry (WCBP), found that patient satisfaction with treatment is achieved through combining broad-based efficacy with a favourable tolerability profile.

The Thinking Ahead Survey,1 included 687 bipolar patients from seven countries (UK, US, Germany, Italy, Canada, Spain and Greece). These preliminary results indicate that:

  • 88% of respondents said drug treatment satisfaction is largely influenced by how effective it is, followed then by patients experiencing few or manageable side effects (77%)

  • 79% of respondents believe that a successful treatment would be one which leads to significant quality of life changes in terms of increased functionality and improved lifestyle

Bipolar disorder, also known as manic-depressive illness, is a severe biological disorder that affects approximately 3-4% of the adult population.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

"As someone who lives with bipolar disorder I need a treatment which can control the manic symptoms but also treat the more disabling depressive symptoms," comments Michael Grinter, SEROQUEL patient and Thinking Ahead Taskforce member. "The treatment that I am currently taking, SEROQUEL, has brought an enormous benefit to my life in terms of controlling both poles of my mood and has enabled me to return to work and live a fully functioning life. It has provided me with the confidence to enjoy each day again."

Recently-published SEROQUEL (quetiapine) data in the Journal of Current Medical Research and Opinion confirm SEROQUEL's efficacy and tolerability in the treatment of bipolar mania symptoms, as a single agent.8

The announcement of these landmark survey results coincides with other important data presented at the WCBP, which address the clinical benefits that SEROQUEL offers bipolar disorder consumers. The preliminary data show that patients with bipolar depression taking SEROQUEL:

  • Showed a statistically significant decrease in levels of depression, as measured by the MADRS* score from week one through to the end of the study2. This study included rapid-cycling patients who often experience symptoms that are more severe and harder to treat than non rapid-cycling patients2

  • Showed significantly greater improvement in anxiety symptoms versus placebo, as measured using the HAM-A** rating scale 3

  • Showed significantly greater improvement in quality of life over placebo by week four (at doses of both 300mg and 600mg), as measured by the Q-LES-Q SF*** questionnaire 4

"The preliminary results from the Thinking Ahead Survey are extremely important and reflect the need for efficacious and well-tolerated treatments to help people living with bipolar disorder to experience real quality of life benefits in terms of symptom control, minimised side effects, and enhanced functioning," comments Dr Eduard Vieta from the University of Barcelona and Thinking Ahead taskforce member. "The data presented this week on SEROQUEL offers real hope for bipolar patients. We know that SEROQUEL can provide broad-based efficacy and trusted tolerability in bipolar disorder and schizophrenia, which allows us to be confident that patients will comply with their treatment in the long-term, thereby significantly improving the likelihood of a successful treatment outcome."

SEROQUEL is licensed in 70 countries for the treatment of mania associated with bipolar disorder, including the US, Canada and several European countries. SEROQUEL has also been licensed for the treatment of schizophrenia since 1997 and is available in 82 countries for the treatment of this condition. To date, more than 8 million people have been treated with SEROQUEL worldwide.

SEROQUEL is not currently licensed for the treatment of bipolar depression. Further updated survey results from the Thinking Ahead Survey will be presented later this year.

*MADRS (Montgomery-Asberg Depression Rating Scale), measures the severity of a number of depressive symptoms including mood and sadness, tension, sleep, appetite, energy, concentration, suicidal ideation and restlessness. The MADRS score decreases as depression symptoms improve.

** HAM-A (Hamilton Anxiety Rating Scale) consists of 14 items that assess anxious mood, tension, fear, insomnia, cognitive symptoms, depressed mood, behavioural indicators, various somatic symptoms.

***Q-LES-Q SF (Quality of Life Enjoyment & Satisfaction Questionnaire Short Form) is a self-administered scale consisting of 16 items assessing social relationships, living or housing situation, and physical health. Higher scores reflect greater life enjoyment and satisfaction.

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Notes to editors:

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 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 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.

About the Thinking Ahead Survey
The Thinking Ahead Survey interviewed people living with bipolar disorder to better understand how their disease impacts their lives and that of their families, how treatment can help and what support they require to ensure their disease has as limited impact as possible on their quality of life. The Thinking Ahead theme was chosen to highlight the need for long term strategies to treat and manage bipolar disorder to ensure that patients achieve full quality of life benefits, as opposed to short term fixes that only add to the stigma and mismanagement of mental illness.

The survey was developed by AstraZeneca and the World Federation for Mental Health, overseen by an independent panel of bipolar disorder physicians and advocacy group representatives, and conducted by Research International, and independent marketing research firm. 687 patients were surveyed from seven countries: UK n=100; US n=203; Germany n=102; Canada n=99, Italy n=100; Spain n=75; Greece n=8. AstraZeneca was the financial sponsor of the survey.

World Federation of Societies of Biological Psychiatry
The World Federation of Societies of Biological Psychiatry is a non-profit world wide organization composed of 60 National Societies of Biological Psychiatry, as well as individual members, and has built in this way a network of 7500 psychiatry professionals from 102 countries all over the globe. The aim of the Federation is to promote, in all countries, education and the attainment of the highest level of knowledge and understanding in the field of Biological Psychiatry.

Global.headquarters@wfsbp.org
www.wfsbp.org

For more information please visit www.astrazeneca.com or contact:

Louise Marland
Global PR Manager, Neuroscience
Mobile: 44-7900-607-794

Lisa O'Sullivan
Shire Health International
Tel: 44-207-108-6515
Mobile: 44-777-033-4917

References:

_____________________________

1. The Thinking Ahead Survey
2. Vieta E et al. Quetiapine for the Treatment of Rapid-Cycling Bipolar Depression. Presented at the World Congress on Biological Psychiatry (WCBP), June 2005, Vienna, Austria.
3. Macfadden W et al. Anti-Anxiety Effects of Quetiapine in Bipolar Depression. Presented at the World Congress on Biological Psychiatry (WCBP), June 2005, Vienna, Austria.
4. Endicott J et al. Efficacy of Quetiapine in Improving Quality of Life in Patients With Bipolar Depression. Presented at the World Congress on Biological Psychiatry (WCBP), June 2005, Vienna, Austria.
5. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385;395.
6. Hirschfield et al. J Clin Psychiatry. 2003:64;53-59.
7. Miklowitz D. The Bipolar Disorder Survival Guide. New York: The Guildford Press, 2002.
8. Vieta E et al. J Cur Med Res and Opin, 2005: 21.


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