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Seroquel Sustained Release Schizophrenia Data Presented at ECP,Congress in Madrid

perienced a significantly reduced risk of relapse (risk reduction of 87 percent, p<0.0001), and a significantly longer time to relapse, compared with those on placebo. Differences in relapse rate between active treatment and placebo were large enough to require the study to be stopped early, in accordance with the study protocol. In the SEROQUEL® sustained release group, the estimated risk of relapse after six months was 14.3 percent versus 68.2 percent in the placebo group (p<0.0001). Hospitalisation due to worsening of schizophrenia was required by 8.3 percent of patients on placebo, but was not needed for any patients taking SEROQUEL® sustained release formulation.

Professor Rene Kahn, Professor and Chair of the Department of Psychiatry and Head of the Division of Neuroscience at the University Medical Center, Utrecht, said: “In these studies SEROQUEL® sustained release formulation showed its potential as a once-daily treatment for both acute and clinically stable schizophrenia. Statistical significance on the primary endpoint was seen at doses between 400 and 800 mg/day and patients achieved that range within two days of starting treatment – that is an advantage over original formulation quetiapine, where the initial dose escalation is not so simple. In mental healthcare, striving for treatment that is simpler and more practical is an important objective for patients and doctors.”

In both studies, somnolence and dizziness were the most common adverse events with SEROQUEL® sustained release formulation and these were generally mild or moderate, transient, and did not lead to withdrawal from the trials. The incidence of extrapyramidal adverse events was similar to placebo (EPS-related adverse events were seen in 5.1 percent of patients taking placebo versus 2.7 percent [400mg], 8.0 percent [600mg] and 4.1 percent [800mg] of patients taking SEROQUEL® sustained release formulation in the acute study).

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