Study shows SEROQUEL may be an effective treatment option in this patient population; analysis shows no evidence of an increased risk of cerebrovascular adverse events
Alderley Park, UK - July 22, 2004 – AstraZeneca announced important new data presented today at the 9th International Conference on Alzheimer's Disease and Related Disorders in Philadelphia, which show that elderly patients with dementia, including those with Alzheimer's disease, who were treated with the atypical antipsychotic SEROQUEL (quetiapine) experienced improvement in symptoms of agitation.1 Additionally, patients treated with SEROQUEL had no cerebrovascular adverse events (CVAEs), which have been associated with the use of some other atypical antipsychotics in this patient population.
Dementia is a term for various progressive brain disorders, the most common being Alzheimer's disease, vascular dementia and dementia with Lewy bodies, that result in a loss of brain function. Symptoms of dementia include memory loss, problems with reasoning, judgement and speech, and the inability to perform everyday tasks.2 Behavioural disturbances, including agitation, have been reported in up to 90% of patients with dementia, which can result in patients becoming distressed and aggressive, putting an immense strain on caregivers and affecting their ability to care for the individuals. 3,4
"Agitation is a significant issue for patients suffering from this condition and their caregivers. It is an aspect of dementia that is both difficult to manage and emotionally troubling for those who care for patients suffering from dementia," said Pierre Tariot, M.D., Professor of Psychiatry, Medicine and Neurology at the University of Rochester. "These new study results are helpful, informative, and justify further investigation of SEROQUEL for agitation in dementia patients."
The STAR trial, a 10-week, multicentred, double-blind, fixed-dose, 3-arm, placebo-controlled trial, randomised 333 institutionalised patients (mean age 83 years) to receive SEROQUEL 200mg/day, SEROQUEL 100mg/day or placebo. The key efficacy measures were the Positive and Negative Syndrome Scale-Excitement Component (PANSS-EC) and Clinicians' Global Impression of Change (CGI-C) scales. These efficacy measures were analysed in the Intent to Treat (ITT) and Per Protocol (PP) populations using the Last Observation Carried Forward (LOCF) and Observed Case (OC) methods. Trial results showed1:
- patients receiving SEROQUEL 200mg/day experienced significantly reduced symptoms of agitation compared to placebo as measured by PANSS-EC scores in three analyses (p<0.05), with a trend towards significance (p=0.065) in the fourth analysis (ITT, LOCF)
- the clinical relevance of the improvement in PANSS-EC is confirmed by the statistically significant improvement in CGI-C scores (p<0.02) in the SEROQUEL 200mg/day group compared with placebo in all four analyses
- no CVAEs were reported in any patients receiving SEROQUEL
- the incidence of postural hypotension was low; incidence of falls and hip fractures were similar among the treatment groups.
Additional results presented today from two pooled, placebo-controlled, 10-week trials, also support the CVAE findings of the STAR trial. 684 patients (mean age 83 years) were randomised to receive SEROQUEL, haloperidol, or placebo. The analysis found that elderly patients receiving SEROQUEL were not at an increased risk of CVAEs, such as stroke or transient ischaemic attacks (TIAs), as demonstrated by the following results5:
- one patient in the SEROQUEL group (0.3%), one patient in the haloperidol group (0.9%) and four patients in the placebo group (1.9%) experienced CVAEs.
SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 81 countries. SEROQUEL is also licensed in 35 countries for the treatment of mania associated with bipolar disorder, including the US and several European countries. To date, over 7 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 world's leading pharmaceutical companies 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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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