To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: APA: Short-term Cognition Improves With Seroquel (Quetiapine Fumarate) for Schizophrenia or Schizoaffective Disorder URL: http://www.pslgroup.com/dg/1FA556.htm Doctor's Guide May 8, 2001
NEW ORLEANS, LA -- May 8, 2001 -- Data being presented today at the American Psychiatric Association annual meeting support that treatment with the atypical antipsychotic Seroquel® (quetiapine fumarate) Tablets significantly improves elements of cognitive function in the study population after only six weeks of treatment (1). Seroquel, a product of AstraZeneca, is indicated for the treatment of schizophrenia. "These data are impressive," says lead researcher Dr. Herbert Y. Meltzer, professor of Psychiatry/Pharmacotherapy and director of Psychopharmacology Division, Vanderbilt University, Nashville, Tennessee. "In this study, patients taking Seroquel quickly demonstrated improvement in verbal working memory. This measure is a significant predictor of functional outcomes such as work function and social interaction." This non-blinded, open-label study involved 19 patients, (14 neuroleptic responders and five neuroleptic resistant) (1), meeting DSM-IV criteria for schizophrenia or schizoaffective disorder (1). The short-term effect of Seroquel was assessed using the following: executive function (Wisconsin Card Sorting Test: Trails B); spatial working memory (Computerized Spatial Working Memory); verbal working memory (Auditory Consonant Trigram); attention/vigilance (Continuous Performance Test [CPT]: Trails A); speeded motor performance (Serial Reaction Time); verbal fluency (Controlled Oral Word Association Test); and fine motor function (Grooved Peg Board Test) (1). In addition, antipsychotic effects were measured using the Brief Psychiatric Rating Scale (BPRS) score for psychopathology; while side effects were measured using the Abnormal Involuntary Movement Scale (AIMS) for tardive dyskinesia (TD), and the Simpson-Angus Scale (SAS) score for extrapyramidal symptoms (EPS) (1). Dosages of Seroquel were titrated to optimal levels (50-800 mg/d) to produce therapeutic effects (1). Cognitive tests and psychopathology assessments were performed at baseline and six weeks after treatment (1). Seroquel with a mean dose of approximately 400 mg/day significantly improved overall psychopathology (BPRS Total: P=0.002) and positive symptoms (BPRS Positive Symptoms: P=0.004)(1). There were also significant improvement in measures of attention, fine motor performance and working memory (1). Improvements in BPRS Total and Positive Symptom scores were significantly correlated with improvement in auditory working memory, but not with other measures of cognition at six weeks (1). Negative symptoms were reduced, but the difference was not statistically significant. Ratings for EPS and TD showed no significant change (1). "The magnitude of the effect of Seroquel on verbal working memory, fine motor performance and attention is impressive for the short period of treatment," notes Dr. Meltzer. "Improvement in cognition may be expected to have functional significance based on studies with other atypical antipsychotic drugs, but longer, prospective studies are needed to affirm this conclusion." The results of this study are consistent with the increasing evidence that Seroquel is an effective antipsychotic that improves cognitive function. In studies supporting the approval of Seroquel, there were no differences from placebo across the clinical dose range in the incidence of EPS, including rigidity and difficulty starting and stopping movement, or in elevation of serum prolactin levels. In addition, studies have shown that Seroquel exhibits a low incidence of hormonal, reproductive system (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation). The efficacy and atypical profile of Seroquel is supported by several placebo- and comparator-controlled Phase II and III clinical trials in patients hospitalized for acute exacerbation of chronic or subchronic schizophrenia. Seroquel was well tolerated by more than 4,000 male and female patients 18 years and older in these trials. No blood monitoring is required. In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given in two divided doses daily. The drug is manufactured in the United States by AstraZeneca and is available by prescription in strengths of 25-mg, 100-mg, 200-mg and 300-mg tablets. Since its approval in September of 1997, there have been more than 3.2 million prescriptions written for Seroquel for more than 851,000 patients in the United States (2,3). As with other agents in its class, the labeling for Seroquel Tablets includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Labeled precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with Seroquel should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events associated with the use of Seroquel are dizziness (10 percent), postural hypotension (7 percent), dry mouth (7 percent), and dyspepsia (6 percent) and the majority of events are rated mild or moderate. The safety and effectiveness of Seroquel in pediatric patients have not been established. References: 1. Lee MA, Meltzer HY. Quetiapine Improves Cognitive Function in Schizophrenia. Poster presented at the APA, May 2001. 2. NDC information services, IMS NPA for prescriptions, as of November 2000. 3. NDC information services, study period through February 2000.
SOURCE: AstraZeneca
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