Wednesday, December 20, 2006

Lack of Awareness and Cultural Stigmas May Prevent Many Latinos from Seeking Treatment for Bipolar Disorde


December 20, 2006
Lack of Awareness and Cultural Stigmas May Prevent Many Latinos from Seeking Treatment for Bipolar Disorder

Overcoming cultural barriers may encourage proper diagnosis and treatment

Wilmington, DE--(HISPANIC PR WIRE)--December 20, 2006--More than seven million American adults are affected by bipolar disorder§, a serious psychiatric condition also known as manic depressive disorder.[1] [2] With an accurate diagnosis and proper treatment, bipolar disorder can be managed.[3] But Latinos often encounter cultural barriers that may prevent them from seeking help and treatment for bipolar disorder. In fact, according to a report from the U.S. Surgeon General on Hispanic Americans and mental health, fewer than one in 11 Hispanic Americans with a mental disorder contact mental health specialists, while fewer than one in five contact general health care providers.[4]

“Despite cultural stigmas associated with mental illness in the Hispanic community, it’s imperative that Latinos understand the signs and symptoms of bipolar disorder, and how misdiagnosis or lack of treatment can have a devastating affect on individuals and their families,” said Daniel B. Martinez, MD, director of medical services at Pilsen-Little Village Community Mental Health Center in Chicago. “Awareness is the first step, and then we must encourage Latinos to talk to their doctors, friends, and families about bipolar disorder.”

Bipolar disorder causes a person’s mood to alternate between the “poles” of mania (highs) and depression (lows). The symptoms of bipolar disorder are more severe than the normal ups and downs of everyday life. For most people with bipolar disorder, the depressive symptoms are often the most debilitating ad can result in damaged relationships, poor job or school performance and even suicide.[3]

But because the depressive symptoms associated with bipolar disorder are also seen in major depressive disorder, a proper diagnosis can be difficult to achieve. In fact, studies show that as many as 69 percent of people with bipolar disorder were misdiagnosed, with the most frequent misdiagnosis being major depressive disorder. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease.[5]

Additionally, once individuals are diagnosed with a disease, treatment plans that include multiple medications may prevent them from sticking to their medication routine. Toward this point, a recent survey of 500 Americans with bipolar disorder suggests that 93 percent of respondents have modified their medication routine in some way without consulting a physician.[6]

But there is good news for people with bipolar disorder: the U.S. Food and Drug Administration (FDA) recently approved SEROQUEL(R) (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL is now the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder.[7] Treatment adherence is an important factor in the management of bipolar disorder.[3]

"The new indication for SEROQUEL will provide physicians and their patients with a new option for treating both the depressive and manic episodes associated with bipolar disorder,” said Mark Scott, executive director--development for SEROQUEL, AstraZeneca. "Utilizing a single medication for the treatment of both acute phases of bipolar disorder may help patients stick to their treatment plan.”

SEROQUEL already is approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. SEROQUEL is the #1 prescribed atypical antipsychotic in the United States.[8] With a well-established safety and efficacy profile, SEROQUEL has had more than 19 million patient exposures worldwide since its launch in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion.

Important Safety Information
SEROQUEL is indicated for the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; and schizophrenia. Patients should be periodically reassessed to determine the need for treatment beyond the acute response.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis. (See Boxed Warning.) Suicidality in children and adolescents—antidepressants increased the risk of suicidal thinking and behavior (4% vs 2% for placebo) in short-term studies of 9 antidepressant drugs in children and adolescents with major depressive disorder and other psychiatric disorders. Patients started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL is not approved for use in pediatric patients. (See Boxed Warning.)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including SEROQUEL. Rare cases of NMS have been reported with SEROQUEL. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure. The management of NMS should include immediate discontinuation of antipsychotic drugs.

Tardive dyskinesia (TD), a potentially irreversible syndrome of involuntary dyskinetic movements, may develop in patients treated with antipsychotic drugs. The risk of developing TD and likelihood that it will become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic drugs administered to the patient increase. TD may remit, partially or completely, if antipsychotic treatment is withdrawn. SEROQUEL should be prescribed in a manner that is most likely to minimize the occurrence of TD.

Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. The relationship of atypical use and glucose abnormalities is complicated by the possibility of increased risk of diabetes in the schizophrenic population and the increasing incidence of diabetes in the general population. However, epidemiological studies suggest an increased risk of treatment-emergent, hyperglycemia-related adverse events in patients treated with atypical antipsychotics. 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 cataracts. Examination of the lens by methods adequate to detect cataract formation, such as slit lamp exam or other appropriately sensitive methods, is recommended at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment.

The most commonly observed adverse events associated with the use of SEROQUEL monotherapy in clinical trials for schizophrenia and bipolar disorder were dry mouth (9-44%), sedation (30%), somnolence (18-28%), dizziness (11-18%), constipation (8-10%), SGPT increase (5%), dyspepsia (5%), lethargy (5%), and weight gain (5%). The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials as adjunct therapy with lithium or divalproex in bipolar mania were somnolence (34%), dry mouth (19%), asthenia (10%), constipation (10%), abdominal pain (7%), postural hypotension (7%), pharyngitis (6%), and weight gain (6%).

Please see full Prescribing Information including Boxed Warnings for SEROQUEL available at .

About Bipolar Disorder
More than seven million American adults are affected each year by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.[1] [2] Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterized by one or more manic or mixed episodes, often with episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode.[9] In the long term, patients with bipolar I disorder experience depressive symptoms -- including prolonged periods of sadness, loss of energy, persistent lethargy, and recurring thoughts of death or suicide[10] – three times longer than manic symptoms.[11] Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania.[9] Bipolar disorder is often misdiagnosed as unipolar depression. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease. In fact, many patients face up to ten years without appropriate treatment before a correct diagnosis is made.[5] Up to 50 percent of patients with bipolar disorder attempt suicide, and approximately 10 to 15 percent complete suicide.[12]

About AstraZeneca
AstraZeneca is a major international health care business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services. It is one of the world's leading pharmaceutical companies with health care sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion health care 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:

This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2005.

[1] Hirschfeld RMA, Calabrese JR, Weissman MM, et al. Screening for Bipolar in the Community. J Clin Psychiatry. 2003; 64:53-59.

[2] U.S. Census Bureau. Available at: .

[3] Bipolar Disorder. National Institute of Mental Health. Available at: Accessed August 28, 2006 .

[4] U.S. Department of Health & Human Services, Office of the Surgeon General. Mental Health: Culture, Race, Ethnicity - Supplement, A Report of the Surgeon General 1999. Available at: .

[5] Hirschfeld RMA, Lewis L, Vornik LA. Perceptions and Impact of Bipolar Disorder: How Far Have We Really Come? Results of the National Depressive and Manic- Depressive Association 2000 Survey of Individuals With Bipolar Disorder. J Clin Psychiatry. 2003; 64:161-174.

[6] DA-SER-47

[7] DA-SER-51

[8] All atypical prescriptions: Total prescriptions Jan 06 to August 06. IMS Health. National Prescription Audit.

[9] American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition Text Revision. Washington DC: 2000.

[10] Judd LL, Akiskal HS, Schettler PJ, et al. The Long-term Natural History of the Weekly Symptomatic Status of Bipolar I Disorder. Arch Gen Psychiatry. 2002; 59:530-537.

[11] Judd LL, Akiskal HS, Schettler PJ, et al. A Prospective Investigation of the Natural History of the Long-term Weekly Symptomatic Status of Bipolar II Disorder. Arch Gen Psychiatry. 2003; 60:26 -269.

[12] Oquendo MA, Chaudhury SR, Mann JJ. Pharmacotherapy of Suicidal Behavior in Bipolar Disorder. Archives of Suicide Research. 2005; 9(3):237-250.

Angela Sustaita
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