Study showed significant improvement in quality of life measures
WILMINGTON, Del, Tuesday May 24 2005 – AstraZeneca (NYSE: AZN) today announced additional findings at the annual meeting of the American Psychiatric Association (APA) from the BOLDER (BipOLar DEpRession) trial, a large-scale study that examined SEROQUEL as a treatment for depressive episodes in patients with bipolar I and II disorders. Results from this trial showed SEROQUEL (600 mg/day and 300 mg/day) significantly improved quality of life measures on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q SF). 1
SEROQUEL is approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. SEROQUEL is currently under investigation for use in the treatment of bipolar depression.
"The depressive phase of bipolar disorder, which patients experience approximately three times as often as the manic phase, is associated with significant impairment in quality of life. Quality of life is of critical importance for patients with bipolar disorder because they often experience relationship and work problems," said Jean Endicott, Ph.D., professor of Clinical Psychology in the Department of Psychiatry at Columbia University and Chief of the Department of Research Assessment and Training at the New York State Psychiatric Institute. "These data from the BOLDER trial are important because they recognize that quality of life is a key dimension of treatment in bipolar disorder."
The BOLDER study, an eight-week, double-blind, placebo-controlled trial, assessed SEROQUEL 300 mg/day and 600 mg/day versus placebo for the treatment of depression in 542 patients with bipolar I and II disorders. Data presented today analyzed quality of life in these patients using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q SF), a 16 item, self-report survey that measures differences in the degree of enjoyment and satisfaction among groups of patients, as well as changes over time in a single patient. The Q-LES-Q SF is a common measurement tool used to assess quality of life in patients experiencing depression.
- Significant improvement was noted at the first post-baseline Q-LES-Q SF assessment (week 4) in both SEROQUEL groups versus placebo (p?0.001) 1
- Q-LES-Q SF mean percentage change scores at final assessment (LOCF) were significantly greater in both SEROQUEL treatment groups (20.9 in the 600 mg/day group and 19.3 in the 300 mg/day group) than in the placebo group (11.5) (p<0.001) 1
- The most common adverse events in the trial included dry mouth, sedation or somnolence, dizziness and constipation 1
"Improved quality of life is key in helping patients manage bipolar disorder symptoms," said Wayne Macfadden, M.D., U.S. Medical Director for SEROQUEL. "The results of this analysis are exciting, and reinforce the importance of additional investigation of SEROQUEL in managing depressive symptoms associated with bipolar disorder."
ABOUT BIPOLAR DISORDER
Bipolar I disorder consists of recurring episodes of mania with or without depression. Bipolar II disorder consists of recurring episodes of hypomania and depression.3 In the long term, patients with bipolar I disorder experience depressive symptoms three times longer than manic symptoms.2 Patients with bipolar II disorder have traditionally been difficult to treat as they spend almost forty times longer in the depressed state than in mania. Without appropriate treatment, patients usually suffer for a lifetime with periods of wellness and functioning punctuated by severe episodes of illness.3 Both men and women are equally at risk for this illness, which most often emerges in adolescence or young adulthood and recurs throughout life.3
IMPORTANT SAFETY INFORMATION
SEROQUEL is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.
AstraZeneca received notice on April 11, 2005, of the US Food and Drug Administration (FDA) request that the product labeling for all atypical antipsychotics, including SEROQUEL, be updated to include a boxed warning noting the increased risk of mortality in elderly patients with dementia-related psychosis taking these drugs, compared to patients taking placebo. The FDA proposed boxed warning also notes that these drugs are not approved for treatment of elderly patients with dementia-related psychosis.
Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.
Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.
Precautions include the risk of seizures, orthostatic hypotension and cataract development.
The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.
For full Prescribing Information for SEROQUEL, please visit the Web site www.seroquel.com
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. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit www.astrazeneca-us.com
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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