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AstraZeneca (AZN) Release: Head To Head Study Confirms Atypical Antipsychotic Efficacy Equivalence



10/24/2005 10:58:21 AM

AMSTERDAM, The Netherlands, October 22 /PRNewswire-FirstCall/ --

- New data also demonstrate SEROQUEL tolerability benefits versus other atypicals in schizophrenia and reinforce therapeutic potential in bipolar disorder

Seroquel (quetiapine), olanzapine and risperidone are equally effective in patients experiencing first episode psychosis, according to data presented today during the Breaking News session* at the European College of Neuropsychopharmacology (ECNP) Congress.[1]

The CAFE (Comparison of Atypicals in First Episode Psychosis) study is the first to examine the comparative effectiveness of SEROQUEL, olanzapine and risperidone in first-episode psychosis patients, as measured by all-cause treatment discontinuation. At week 52, the all-cause treatment discontinuation rates were similar between medications (70.9 percent, 68.4 percent and 71.4 percent for SEROQUEL, olanzapine and risperidone, respectively). However, significantly more olanzapine patients (80 percent) experienced weight gain of seven percent or more relative to baseline, compared with 57.6 percent of risperidone and 50 percent of SEROQUEL patients (P=0.01 olanzapine vs SEROQUEL).

Commenting on the data, Professor Henry Nasrallah, Professor of Psychiatry, Neurology, & Neuroscience at the University of Cincinnati Medical Center, USA said that the CAFE study shows the three atypicals had similar rates of discontinuation and similar secondary efficacy outcomes. "These data confirm that SEROQUEL, olanzapine and risperidone show equivalent efficacy in the treatment of first episode psychosis. In addition, they provide clinicians with further guidance on the optimal dosing for agents such as SEROQUEL in first episode treatment situations," Professor Nasrallah said.

The mean modal prescribed daily doses in CAFE were 506 mg for SEROQUEL, 11.7 mg for olanzapine and 2.4 mg for risperidone. However, Professor Nasrallah said it was important to remember that in chronic schizophrenia, patients generally need higher doses of medication and clinicians should explore the full dose ranges of medications.

The overall discontinuation rate observed among patients in this study reflects the complexities in treating people with schizophrenia, a severe mental illness which affects about one percent of people.

"The study reinforces the need for a variety of medications so that clinicians can find the best treatment option, with optimal risk benefit ratio, for each patient. It also highlights how important patient-physician communication is in maximizing treatment success," said Professor Nasrallah.

Other data presented at ECNP confirm that SEROQUEL (final mean dose 709.8 mg) and risperidone (final mean dose 8.1 mg per day) are equally effective in the acute management of schizophrenia, however SEROQUEL offers tolerability benefits.[2] The results of the acute phase of the TESIS study (Tolerability and Effectiveness of Seroquel In Patients with Schizophrenia)* show that patients responded similarly to both medications: 66.3 percent of SEROQUEL and 57.1 percent of risperidone patients showed at least 40 percent improvement of Brief Psychiatric Rating Scale scores. More patients experienced extrapyramidal side-effects (inability to control muscle movements) with risperidone than with quetiapine: rigidity (25.7 percent vs 3.8 pecent, P<0.001), hypokinesia/akinesia (29.1 percent vs 6.6 percent, P<0.001), tremor (22.7 percent vs 3.4 percent, P<0.001) and akathisia (12.7 percent vs 1.9 percent, P<0.001). In addition, quetiapine had less impact on male sexual functioning; diminished sexual desire (18.8 percent vs 6.7 percent, P=0.012) and erectile dysfunction (21.1.percent vs 5.9 percent, P=0.003) were more common in males treated with risperidone compared to quetiapine.

SEROQUEL in bipolar disorder

Newly data presented at ECNP also evaluate SEROQUEL's therapeutic potential in bipolar disorder. Top-line results from the BOLDER II (BipOLar DEpRession) study, which will be presented at the AstraZeneca satellite symposium on Monday 24 October, underline the potential for SEROQUEL in the treatment of patients with major depressive episodes associated with bipolar disorder[3]. In BOLDER II, SEROQUEL 300mg and 600mg doses achieved a statistically significant reduction in levels of bipolar depression compared with placebo (p less than or equal to 0.001), as measured by the change from baseline in Montgomery- Ã?Â?sberg Depression Rating Scale (MADRS) total score.[4]

BOLDER II, an eight week, multi-centre, placebo-controlled study, reinforces the findings of the landmark BOLDER I study[5], which first indicated a significant effect for SEROQUEL in treating major depressive episodes associated with bipolar disorder.

Professor Joseph Calabrese, co-director of the National Institute of Mental Health Bipolar Research Center at University Hospitals of Cleveland and Case Western Reserve University says: "Patients with bipolar depression are underserved and understudied. The findings from the BOLDER II study are very encouraging and support the findings of BOLDER I, in showing the potential of SEROQUEL, as monotherapy, for the acute treatment for bipolar depression. Each of these two studies represent the largest placebo-controlled short-term studies ever conducted in bipolar depression. The beneficial risk:benefit profile of Seroquel seen in both studies could offer an important therapeutic value for both patients and physicians as we currently have only one FDA-approved therapy to treat depressive episodes associated with bipolar disorder."

Results of a study by Carta et al* will also be presented at ECNP and the results show that SEROQUEL is effective in the prevention of both manic and depressive episodes in patients with bipolar disorder who were not responding adequately to ongoing medications.[6] When SEROQUEL was given for an average of 18.1 months as an additional treatment, the relapse rate into manic or depressive episodes was significantly reduced (P<0.001). This reduction was particularly pronounced for depressive episodes: patients had an average relapse rate of 0.05 depressive episodes per month prior to receiving SEROQUEL, which was reduced to 0.01 episodes per month when taking SEROQUEL (P<0.001).

The recent Thinking Ahead survey of people with bipolar disorder showed that patients believe successful treatment would significantly improve their quality of life and that they are looking for treatment options offering efficacy and tolerability.

SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 85 countries for the treatment of this condition. SEROQUEL is also licensed in 73 countries for the treatment of mania associated with bipolar disorder, including the US, Canada and several European countries. To date, approximately 13 million people have been treated with SEROQUEL worldwide.

SEROQUEL is a trademark of the AstraZeneca group of companies. For further information about SEROQUEL, please visit www.astrazenecapressoffice.com. Further information is also available at the psychiatry resource internet site www.psychiatry-in-practice.com.

*Notes to Editors:

- The ECNP Breaking News session takes place from 18.00-19.15 in the poster area of The Amsterdam International Fairs & Congress Centre (RAI)

- The TESIS study was a multicenter, prospective, non-randomized, comparative, naturalistic study. Patients >=18, who were admitted in an acute psychiatric unit, met DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder, and who, as part of the normal clinical practice, were prescribed QUE or RIS within first seven days after admission were included in a 3:1 ratio. A total of 436 patients were recruited to the study and 435 were considered evaluable, 323 in the QUE group and 112 in the RIS group.

- The study by Carta et al involved 42 patients (22 males, mean age 42 +/- 18.0 years and 20 females, mean age 53 +/- 18.44 years), who were observed for an average of 9.5 months (range 3-18 months) before the addition of QTP at a mean daily dose of 535 +/- 54.5 mg. Patients were subsequently followed for an average of 18.1 months (range 6-42 months)

References:

[1] Comparison of Atypicals in First-Episode Psychosis - a randomised, double-blind, 52-week comparison of olanzapine, risperidone and quetiapine. Presented by R. Keefe. at the Breaking News session at the 18th ECNP congress, The Netherlands, 2005

[2] Rico-Villademoros F. Tolerability and effectiveness of Quetiapine in inpatients with schizophrenia: Results of the acute phase of the TESIS Study. Poster presented at the 18th ECNP congress, Amsterdam, The Netherlands, 2005.

[3] Bipolar disorder: a multidimensional illness requiring a multifaceted approach. Satellite symposium at the 18th ECNP congress. Amsterdam, The Netherlands, 2005.

[4] Data on file

[5] Calabrese JR et al. Am J Psychiatry 2005;162:1351-60.

[6] Carta et al. Quetiapine in long-term add-on therapy of patients with bipolar I disorder inadequately responsive to treatment. Poster presented at the 18th ECNP congress, Amsterdam, The Netherlands, 2005.

AstraZeneca

CONTACT: Alternatively please contact: Louise Marland, AstraZeneca, Tel:+44-(0)-1625-510782 Mobile: +44-(0)-7900 607794 Email:louise.marland@astrazeneca.com Lucy Turvill, Hill & Knowlton, Tel:+44-(0)-20-7413-3508 Mobile: +44-(0)7810528368 Email:lturvill@hillandknowlton.com


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