To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ECNC: Seroquel (Quetiapine Fumarate) Reduces Psychosis In Chronic Schizophrenia, Parkinson's Patients URL: http://www.pslgroup.com/dg/1E12B6.htm Doctor's Guide September 14, 2000
WILMINGTON, DE -- September 14, 2000 -- Patients experiencing symptoms of psychosis were given new hope during a presentation by researchers given this week at the l3th European College of Neuropsychopharmacology Conference in Munich, Germany. Scientists presented evidence from two new clinical studies that suggest treatment with the atypical antipsychotic Seroquel® (quetiapine fumarate) Tablets significantly improved cognitive function in some patients with chronic schizophrenia or Parkinson's disease who experience symptoms of psychosis. (1)(2) A six-month, open-label study compared cognition in 29 patients with Parkinson's disease experiencing psychotic symptoms treated with Seroquel to baseline and to 12 nonpsychotic patients who were not treated with Seroquel. The study, conducted by Dr. Jorge L. Juncos and Dr. Rita D. Jewart at Emory University School of Medicine in Atlanta, Ga., assessed cognitive function before and after six months of Seroquel therapy. Patients with Parkinson's disease experiencing psychotic symptoms who received Seroquel treatment experienced significant improvement in their ability to remember information and remain attentive compared to baseline, while the control group exhibited no change in delay story recall and significant decline in sustained attention. "Psychosis is a mental disorder that impairs a person's ability to recognize reality, communicate, and relate to others," said Dr. Juncos. " Seroquel has been shown to effectively treat the psychotic symptoms without the impairment of a person's ability to interact with the outside world. This study shows Seroquel may benefit some Parkinson's disease patients experiencing psychotic symptoms by strengthening their capacity to function in society." In a study of patients with chronic schizophrenia, those receiving Seroquel (quetiapine fumarate) Tablets had significant improvement compared with patients receiving haloperidol in a number of aspects of cognitive function, including organization and planning, movement control, learning, and memory. Dr. Jonathan Hellewell of Trafford General Hospital in Manchester, England, presented an analysis of two double-blind studies comparing six months of Seroquel treatment with that of haloperidol in patients with chronic schizophrenia. In the first study involving 58 patients, cognitive performance on standardized verbal and memory recall tests improved more with Seroquel therapy 600 mg per day than with Seroquel 300 mg per day or with haloperidol 12 mg per day. In the second study involving 25 patients, significant improvements in measures of executive and motor function, learning and memory were acted in the Seroquel group, whereas the haloperidol group exhibited improvements in only visuomotor tracking with alteration and story recall. "These studies complement one another in demonstrating the efficacy of Seroquel in improving cognitive function in individuals with schizophrenia. This leads to growing optimism that Seroquel can not only control symptoms of schizophrenia but may also improve social, occupational and inter-personal function," said Dr. Hellewell. Psychosis associated with Parkinson's disease and chronic schizophrenia impairs the quality of life of both the patient and the family or caregiver. Mental status changes, while treatable, can remain untreated because of a stigma and lack of awareness among Parkinson's patients and caregivers. For patients with chronic schizophrenia, improved cognitive function may allow some individuals to maintain employment, attend school, or possibly live independently despite their condition. (3) Seroquel is indicated for the management of the manifestations of psychotic disorders. 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 plasma 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 (NYSE: AZN) and is available by prescription in strengths of 25-mg, 100-mg, and 200-mg tablets. Since its approval in September of 1997, there have been more than 2.4 million prescriptions written for Seroquel for more than 623,000 patients in the United States.(4)(5) 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). Labeling 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 exhibited across placebo-controlled trials included headache (19 percent), somnolence (18 percent), and dizziness (10 percent), and the majority of events were rated mild or moderate. The safety and effectiveness of Seroquel (quetiapine fumarate) Tablets in pediatric patients (less than 18 years of age) have not been established. References: (1) Juncos JL, Jewart RD, et al. Tolerability, Efficacy and Cognitive Effects of Quietiapine in Patients with Parkinson's Disease Treated for Psychotic Symptoms. Poster presented at the 13th European College of Neuropsychopharmacology Conference in Munich, Germany, September 11-13, 2000. (2) Hellewell JSE, The Effect of Quetiapine (Seroquel) in Improving Cognitive Impairment in Schizophrenia. Poster presented at the 13th European College of Neuropsychopharmacology Conference in Munich, Germany, September 11-13, 2000. (3) Excerpt from National Parkinson Foundation, Inc. Website, p. 10, Adapted from publications distributed by the Parkinson Foundation of Canada, Taking Charge: A Guide to Living with Parkinsonism and The Tangled Web: Mental Status Changes in Parkinsonism. (4) Source(TM)Prescription Audit (SPA) 27-Month Period Ending January 2000, Scott Levin, a division of PMSI Scott-Levin, Inc. (5) NDC Health Information Services, SEROQUEL Patient Tracking Analysis. 26-Month Period Ending December 1999. Related Link: Seroquel (quetiapine fumarate). --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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