"Unfortunately bipolar depression is associated with high suicide rates, with 25% to 50% of people with the illness attempting suicide " commented Professor Joseph Calabrese, Co-Director of the Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University School of Medicine. "These data suggest a brighter future for patients with bipolar disorder as they illustrate that those treated with SEROQUEL benefit from a strong efficacy profile, combined with improved compliance and quality of life – three factors in antipsychotic treatment that are intrinsically linked. The fact that this strong efficacy profile includes an ability to reduce suicidal thinking is a significant benefit and is encouraging news for clinicians who are striving to deliver meaningful results for their patients."
Reducing suicidal thinking key to reducing high suicide rates: These data, from the BOLDER (BipOLar DEpRession) trial1, an eight week, multi-centre, randomised, double-blind, placebo-controlled study involving 542 patients with a diagnosis of bipolar I or II disorder, showed that SEROQUEL (600 and 300 mg/day) is approximately twice as effective in reducing suicidal ideation by week eight as placebo. The results were analysed using standard clinical scales to assess improvements in depressive and anxiety symptoms. Additional results from the BOLDER study showed:
- SEROQUEL (600 and 300 mg/day) significantly improved the core symptoms of depression as early as week one onwards (symptoms include apparent sadness, reported sadness, inability to feel, suicidal thoughts, and pessimistic thoughts)
- A significant improvement in anxiety symptoms occurred as early as week one and was maintained to study end (P<0.001 for both doses).
"This is the first time we've seen an atypical antipsychotic demonstrate this level of efficacy in reducing suicidal thinking in bipolar disorder. Reducing the thought processes that can lead to suicide is vital if we are to be successful in our efforts to reduce the high suicide rates we currently see in bipolar disorder" continued Professor Calabrese. "This is a particularly stressful and sensitive area for both patients and their families, and these robust results support further research into SEROQUEL's use in this area."
Improving quality of life and treatment adherence:
Bipolar depression is also associated with a significant impairment on patients' quality of life. Further new data from the BOLDER trial2 presented at the APA meeting demonstrate a significant improvement in quality of life for patients with bipolar depression who are treated with SEROQUEL (600 and 300 mg/day). Results were analysed using a 16-item questionnaire that measures differences in the degree of enjoyment and satisfaction among groups of patients, as well as changes over time in a single patient. Results showed:
- SEROQUEL is effective in improving quality of life as demonstrated by the improvement in Q-LES-Q SF score which was significantly greater in both SEROQUEL treatment groups (11.7 in the 600 mg/day group and 10.8 in the 300 mg/day group at final assessment) than in the placebo group (6.4, p<0.001)
- Significant improvement in quality of life was noted at the first questionnaire (Q-LES-Q SF) assessment (week 4)
- SEROQUEL was generally well tolerated, with low levels of extrapyramidal side effects and minimal weight gain.
Commenting on the results, lead study investigator Professor J Endicott, from the New York State Psychiatric Institute, US, said "Bipolar disorder patients are often highly capable individuals who have jobs and relationships to maintain. Maintaining a high quality of life is therefore of critical importance."
Treatment adherence data supported:
These data are supported by new results from another study assessing treatment adherence to antipsychotic monotherapy in bipolar disorder.3 A total of 18,158 antipsychotic monotherapy treatment episodes for bipolar and manic disorders were identified from a claims database in the United States. Adherence measures included treatment compliance, captured by regularity of prescription refills, and treatment duration. Atypical antipsychotics included SEROQUEL, risperidone, olanzapine, and ziprasidone; conventional antipsychotic agents included haloperidol, perphenazine, thioridazine, and thiothixene. Results showed:
- SEROQUEL alone had significantly (P<0.05) greater compliance than the conventional agents and had the highest compliance among the atypicals, which was significantly greater than for risperidone or olanzapine
- Daily dose was negatively associated with compliance for all agents except SEROQUEL (P<0.05 for risperidone and the conventional agents), which had a positive, but non-significant association (P=0.074).
"These data suggest a strong link between improving treatment compliance and maintaining quality of life. Patients are most likely to benefit from treatments, such as SEROQUEL, that can deliver in both these areas" concluded Professor Endicott.
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. , , , 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. A medication's overall efficacy and tolerability profile is therefore vital to helping patients comply with their medication.
SEROQUEL is licensed in 63 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, over 8 million people have been treated with SEROQUEL worldwide. SEROQUEL is currently not licensed for the treatment of bipolar depression.
Notes to editors:
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 trade mark of the AstraZeneca group of companies.
For more information, please visit www.astrazenecapressoffice.com or please contact:
Sarah Fraser at Shire Health International
Tel: 1-212-329-6272
sarah.fraser@newyork.shirehealth.com
References: MacFadden W. Treatment Effects of Quetiapine in Bipolar Depression. Presented at the American Psychiatric Association meeting, May 2005, Atlanta, USA
Endicott J, Rajagopalan K, Macfadden W, Minkwitz M, Gaddy J. Efficacy of quetiapine in improving quality of life in bipolar depression. Presented at the American Psychiatric Association meeting, May 2005, Atlanta, USA
Gianfrancesco FD, Rajagopalan K. Treatment Adherence With Antipsychotics Among Bipolar and Manic Patients. Presented at the American Psychiatric Association meeting, May 2005, Atlanta, USA
Goodwin FK, Jamison KR. Manic Depressive Illness. New York Oxford University Press; 1990 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385;395.
Hirschfield et al. Screening for bipolar disorder in the community. J Clin Psychiatry. 2003:64;53-59.
Lish 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.
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.
Miklowitz D. The Bipolar Disorder Survival Guide. New York: The Guildford Press, 2002.