Clinical data recently presented at a major US psychiatric conference suggest that Seroquel ® (Quetiapine Fumarate) Tablets continue to be safe, effective and well-tolerated in the long-term treatment of both positive and negative symptoms of schizophrenia in adults.
Positive and negative symptoms of schizophrenia
Major features of schizophrenia include positive symptoms such as delusions, and hallucinations, and negative symptoms such as apathy, depression, and social withdrawal. While older antipsychotic medications have frequently been used to relieve the positive symptoms of schizophrenia, the newer class of atypical antipsychotic medications including Seroquel, have been shown to be effective in controlling both the negative and positive symptoms.
“Approximately one in every 100 people develops schizophrenia. This psychiatric disorder occurs worldwide despite a person’s gender, culture, ethnicity and religion,” said Jonathan Hellewell, Department of Psychiatry, Trafford General Hospital, Manchester, United Kingdom and lead author of one of the studies. “Typically, schizophrenia is a lifelong illness with symptoms that change in severity over time. It is therefore critical to maintain treatment for a long period of time.”
Assessment of long-term efficacy with Seroquel
Results from one analysis suggest that, among adult patients with schizophrenia and elderly patients with psychosis who showed an initial response to Seroquel treatment, the medication offers maintained response for both positive and negative symptoms of schizophrenia over the long-term.
Results were gleaned from data collected from 52-week, open label extension (OLE) trials of three studies in adults (n=267), and one study of elderly patients (n=184). Patients who had a meaningful clinical response to Seroquel in the acute phase were eligible for the OLE phase.3 Response was defined as 40 percent reduction in Brief Psychiatric Rating Scale (BPRS) total score from baseline or a BPRS total score of 18 points at week six.
In the three OLE studies, improvements in symptoms were maintained over 52-week study period as measured by each assessment scale utilized in the study. (BPRS 14.0 vs. 12.7; CGI Severity Illness 3.0 vs. 2.8; BPRS Positive Symptom Cluster score 1.3 vs. 1.0; and Scale for Assessment of Negative Symptoms 9.5 vs. 8.2) The analysis of the elderly patients also suggested that the efficacy of Seroquel was maintained during the treatment period.
Seroquel (quetiapine fumarate) continued to be well tolerated throughout the OLE treatment period. No new safety issues were identified in adult patients. Safety in elderly patients was confirmed by the low rate of withdrawal for adverse events (15%).
The most common adverse events associated with the use of Seroquel are dizziness (10%), postural hypotension (7%), dry mouth (7%) and dyspepsia (6%) and the majority of events are rated mild or moderate.
Assessment of long-term efficacy and safety of Seroquel in the treatment of schizophrenia
Results of a second analysis were gathered from data collected from four open label extension (OLE) studies in which 674 patients with schizophrenia (65.6 percent male), with a mean age of 36.4 years received Seroquel for up to 130 weeks. Various assessment scales i for mental illness were used to measure the long-term efficacy and tolerability of Seroquel. Each measurement suggested a continued improvement in efficacy up to the end of the study. Study results indicated Seroquel was well-tolerated during long-term therapy with significant improvements from baseline observed at 13, 26, 52, 65, 78, 91, 104 and 130 weeks.
“We were pleased to see that Seroquel continues to maintain its effectiveness for treatment of both the positive and negative symptoms of schizophrenia for patients who require long-term treatment,” said Siegfried Kasper, M.D., Professor of Psychiatry and Chairman of the Department of General Psychiatry at the University of Vienna, Austria, and lead author of the study. “With medications such as Seroquel (quetiapine fumarate), patients suffering from schizophrenia may now continue taking an effective medication that has been shown to improve their symptoms for an extended period of time.”
The effectiveness of Seroquel in long-term use, that is, for more than six weeks, has not been systematically evaluated in controlled trials.
Safety during long-term exposure to Seroquel
Data from a third analysis evaluated the long-term safety of Seroquel for patients treated for up to three years during the open-label extension (OLE) phases of the Seroquel Phase IIIb clinical trial program. A total of 478 patients with a mean age of 39 years who were diagnosed with schizophrenia or schizoaffective disorder were included in the assessment.
The median duration of exposure to Seroquel was 30 weeks. Mean daily doses during OLE treatment averaged between 450-500 mg throughout the three year period. Adverse-event profile during open-label treatment was similar to that observed during the randomized periods of the individual trials, no safety concerns were raised.
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