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 This lack of compliance is strongly associated with the occurrence of side effects, therefore, a well tolerated and effective treatment is pivotal to the successful treatment of this condition.
Results from two 12-week trials each involving 302 patients were presented at ICBD. Of key importance, Seroquel was found to be fast-acting as combined analysis from both trials found that a significant greater reduction in mean Young Mania Rating Scale (YMRS) total score was achieved from as early as day 4 (p=0.021).
The first trial involving 302 patients who were randomised to Seroquel, placebo or haloperidol, found:
- patients on Seroquel had a significantly greater reduction in mean YMRS total score vs placebo after three weeks (-12.29 vs -8.32; p = 0.0096), this 3.97 difference in score increased to 8.04 by day 84 (p<0.0001)
- significantly more Seroquel-treated patients achieved a response of =50% decrease from baseline YMRS score at day 84 than the placebo group (48.1% and 31.3% respectively, p = 0.0006)
- patients on haloperidol were six times more likely to suffer from side effects known as extrapyramidal symptoms (EPS) than patients on Seroquel (35.4% and 5.9% respectively)
- discontinuation due to adverse events were more than double in the haloperidol group than in the Seroquel group (10.1% vs 4.9% respectively).
The second trial involving 302 patients who were randomised to Seroquel, placebo or lithium found:
- patients on Seroquel had a significantly greater reduction in mean YMRS scores vs placebo after three weeks (-14.62 vs -6.71; p<0.001), this 7.91 difference in score increased to 11.28 by day 84 (p<0.001)
- significantly more Seroquel-treated patients achieved a response of = 50% decrease from baseline YMRS score at day 21 than the placebo group (53.3% and 27.4% respectively, p<0.001) increasing by day 84 (72% and 41.1% respectively, p<0.001)
- Seroquel to be well tolerated without the emergence of EPS or prolactin elevation.
As Dr Joseph Calabrese, Case Western University School of Medicine, Cleveland, Ohio commented, "The efficacy of Seroquel in the treatment of mania associated with bipolar disorder combined with high tolerability is good news for patients and psychiatrists. The standard treatments available, although effective in controlling the symptoms, can cause debilitating side effects which can ultimately lead to patients stopping their medication. As these results show, here we have a treatment option - Seroquel - that both works and is well tolerated, enabling our patients to continue with their everyday lives."
These two 12-week, double-blind, randomised, placebo-controlled trials were designed to evaluate the efficacy and safety of Seroquel monotherapy compared with placebo for the treatment of mania in a large cohort of adults with bipolar I disorder. A total of 302 patients experiencing a manic episode were recruited into each trial and were assigned Seroquel at doses of up to 800 mg/day, placebo, lithium or haloperidol. The majority of patients who responded to Seroquel were in the dose range of 400 – 800mg/day and the average dose of Seroquel in the trials at endpoint was approximately 600mg/day.
These results support a previous study's findings which showed Seroquel in combination with lithium or divalproex to be significantly more effective than lithium or divalproex alone in treating bipolar mania.8 The data from the studies are from a series of Phase III trials that evaluated the efficacy, tolerability and safety of Seroquel as adjunct and monotherapy treatment for bipolar mania. AstraZeneca announced its submission of a Supplemental New Drug Application to the U.S. Food and Drug Administration in January 2003 and to the 14 European Member States involved in the Mutual Recognition Procedure in February 2003, for Seroquel to be granted a licence for the treatment of manic episodes associated with bipolar disorder (manic-depressive illness).
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 $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
For more information, please visit http://www.astrazenecapressoffice.com
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.
Notes to Editors:
'Seroquel' is a trademark of AstraZeneca
YMRS (Young Mania Rating Scale) is an 11-item instrument used to assess the severity of mania.
For further information contact:
or
Ellie Goss at Shire Health International
For an electronic and downloadable version of this press release or for further information about Seroquel, please visit the psychiatry resource internet site at: http://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:
2. Paulsson B & Huizar, K. Quetiapine Monotherapy for the Treatment of Bipolar Mania. Poster presented at 5th International Congress on Bipolar Disorder, Pittsburgh, 2003
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. J Clin Psychiatry. 2003;64:53-59
5.Lisd 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 Guilford Press, 2002.
8. Sachs G, Mullen JA, Devine NA. Quetiapine vs placebo as adjunct to mood stabilizer for the treatment of acute mania. Bipolar Disorders. 2002;4(issue S1);Abs 61:133.
Jim Minnick at AstraZeneca
Tel: 1-302-886-5135
jim.minnick@astrazeneca.com
Tel: 44-0-207-471-1500
ellie.goss@shirehealthinternational.com
1. Brecher M & Huizar, K Quetiapine Monotherapy for Acute Mania Associated With Bipolar Disorder. Poster presented at 5th International Congress on Bipolar Disorder, Pittsburgh, 2003