Clinical study data showed SEROQUEL improved overall cognitive function in patients with schizophrenia; Database analysis showed greater compliance with atypical antipsychotics
WILMINGTON, Del., Monday May 23 2005 – AstraZeneca (NYSE: AZN) today announced results from a clinical study that examined the effectiveness of SEROQUEL and risperidone in improving cognitive function, such as memory and attention, in patients with schizophrenia. This study, which was presented at the annual meeting of the American Psychiatric Association (APA), showed that SEROQUEL and risperidone improved overall cognitive function and social skills performance in this patient population.1 In addition, an analysis of a large health claims database showed that patients with schizophrenia taking atypical antipsychotics, including SEROQUEL, exhibited greater treatment compliance than those taking conventional antipsychotic treatments.2
SEROQUEL currently is approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia.
"Cognitive function and treatment compliance are important components to the successful, long-term management of schizophrenia. Specifically, patients who take medications that are effective and well tolerated, and who stick to that treatment, are more likely to manage their illness successfully," said Philip Harvey, Ph.D., Department of Psychiatry, Mount Sinai School of Medicine. "The results of these studies reconfirm the tolerability of SEROQUEL, as measured by treatment adherence, and its ability to improve cognitive function in patients with schizophrenia."
For patients with schizophrenia, cognitive functioning often is impaired, which can be a significant barrier to long-term recovery.1 To date, few studies have directly compared atypical antipsychotics for the treatment of cognitive function.1
Data presented today, drawn from an 8-week, double-blind, flexible-dose, parallel study of 673 schizophrenia patients randomized to treatment with SEROQUEL (mean modal dose of 525 mg/day) or risperidone (mean modal dose of 5.2 mg/day), analyzed the cognitive benefits of both medications. Cognitive assessments including memory, verbal fluency and executive function, as well as a social skills performance-based measure, were conducted at baseline and at endpoints. Data showed that both SEROQUEL and risperidone were associated with overall improvements in cognitive functioning (p<0.01) versus baseline, with no significant differences between the treatment groups (p= 0.84).1
"Deficits in social functioning are a major barrier to recovery in schizophrenia," added Dr. Harvey. "The results of this study show that SEROQUEL at an appropriate dose has a beneficial effect on social competence even at 8 weeks, with part of this improvement associated with improvements in memory and speed of cognitive processing."
In an analysis of a large health claims database, also presented today, that studied 7,216 antipsychotic monotherapy treatment episodes in patients with schizophrenia, several atypical antipsychotics (SEROQUEL, risperidone, olanzapine, and ziprasidone) and conventional antipsychotics (haloperidol, perphenazine, thioridazine, and thiothixene) were compared with respect to treatment compliance and duration of treatment.
- Data showed that patients in the atypical antipsychotic group experienced greater treatment compliance than patients in the conventional antipsychotic group.2
"In serious mental illnesses such as schizophrenia, treatment compliance is crucial to the overall management of the condition," said Kitty Rajagopalan, Ph.D., Director, Health Economics and Outcomes Research, AstraZeneca Pharmaceuticals LP. "Effective treatments such as SEROQUEL, when taken persistently, help ensure improved patient outcomes."
Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, confused thinking, and flat or blunted emotions.3 The first signs of schizophrenia typically emerge in the teenage years or early twenties.3 Almost 2.2 million Americans – or 8 out of every 1,000 people – suffer from schizophrenia.4 Medications are important in the management of symptoms.5 Approximately 70 percent of patients with schizophrenia clearly improve when treated with antipsychotic drugs,4 which are classified into two categories -- "typical" and "atypical" antipsychotics.4
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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