Alderley Park, UK - June 23, 2004 - AstraZeneca announced important new data today from three separate studies presented this week at the 24th Collegium Internationale Neuro-Psychopharmacologicum (CINP) meeting in Paris.
The studies show that patients with schizophrenia who are treated with SEROQUEL (quetiapine) experience an overall improvement across a broad range of symptoms associated with schizophrenia, including both positive and negative symptoms, and cognitive functioning. These data add to the extensive set of clinical evidence demonstrating SEROQUEL's efficacy and tolerability in treating schizophrenia.
Results from the first study, the largest 8-week, double-blind, randomised clinical trial to date comparing SEROQUEL and risperidone in the treatment of patients with schizophrenia, show SEROQUEL to be as effective as risperidone at improving the overall cognitive functioning of patients with schizophrenia.1. Cognitive deficiencies can be highly debilitating to patients with schizophrenia and can potentially compromise patient compliance, increasing the risk of relapse. At week 8, the overall improvement in cognitive functioning in patients treated with SEROQUEL was supported by significant improvements in specific aspects of cognitive functioning related to functional outcome: phonological fluency (p<0.01); learning and delayed recall (p<0.05); and social skills performance (p<0.01). The study included 673 acutely ill patients with schizophrenia who were randomised to treatment with SEROQUEL (mean daily dose 525 mg/day) or risperidone (mean daily dose 5.2 mg/day).
Commenting on the results, Dr. Philip Harvey from the Department of Psychiatry at the Mount Sinai School of Medicine in New York, USA, and lead investigator of the study, said, "For patients with schizophrenia, the inability to function in everyday life - think clearly, interact with other people, even write a letter - can have a devastating impact on their quality of life. Improving the cognitive functioning of patients is an essential element of any successful treatment strategy for schizophrenia and an important factor in allowing patients to reintegrate into society more easily. Clinicians should therefore be encouraged by these results, which confirm SEROQUEL's efficacy in this important symptom area."
The second study, conducted by Dr. Michael Riedel from Munich University Hospital, Germany, was a 12-week, double-blind, randomised parallel group comparison of SEROQUEL and risperidone in 44 schizophrenic patients who showed predominantly negative symptoms.2 The study demonstrated the similar efficacy of the two agents and also highlighted SEROQUEL's better tolerability.2 Specifically the results show:
- Both SEROQUEL and risperidone produced significant improvements in PANSS total and negative subscale scores (all p less than or equals to 0.01) compared with baseline
- Patients treated with risperidone had a significant increase from baseline (p less than or equals to 0.05) in the incidence and severity of extrapyramidal (EPS) at Weeks 3, 4, 5 and 7, whereas no significant increases in EPS were observed in Seroquel treated patients at any time.
Results from the third study, presented again this week at CINP, support the proven efficacy of SEROQUEL in treating the positive symptoms of schizophrenia, and again highlight SEROQUEL's superior tolerability profile. Conducted by Professor Emilio Sacchetti, from the Brescia School of Medicine, Italy, the 16-week, multicentre, randomised parallel-group, rater-blinded, flexible dose study of 65 patients with schizophrenia, was the first direct comparison of SEROQUEL, olanzapine and risperidone in this setting.3 Specifically the results show:
- At week 8 PANSS total scores were improved by 34% with SEROQUEL, 30.0% with olanzapine and 29% with risperidone
- With respect to EPS, improvements in the SAS score was observed for SEROQUEL (-0.1 change from baseline by week 8) and olanzapine (-0.5 change from baseline by week 8), whilst a deterioration in SAS score was observed for risperidone (+2.4 change from baseline by week 8).
- At week 8, weight gain of >5% from baseline was observed in 37.5% (olanzapine), 28% (risperidone) and 16% (SEROQUEL) of patients.
SEROQUEL is manufactured by AstraZeneca and has been licensed for use in schizophrenia since 1997 and is available in 81 countries. Seroquel combines broad-based efficacy in the treatment of positive, negative, cognitive and affective symptoms of schizophrenia, while offering excellent tolerability. SEROQUEL is associated with an incidence of EPS and prolactin elevation no different to placebo across the full dosage range, a favorable weight profile in long-term use, and no clinically important effects on QT interval in most patients. To date, over 4 million people have been treated with SEROQUEL worldwide.
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 top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.
For more information, please visit http://www.astrazenecapressoffice.com
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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Show me a sane man and I will cure him for you.
-- Carl Jung