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The British Journal of Psychiatry (2007) 191: 86. doi: 10.1192/bjp.191.1.86
© 2007 The Royal College of Psychiatrists
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Correspondence

Aripiprazole - data on efficacy and associated mortality

G. A. Silver

Bristol-Myers Squibb, Uxbridge, UK

R. Gutierrez-Esteinou

Bristol-Myers Squibb, Princeton, New Jersey, USA. Email: rolando.gutierrez-esteinou{at}bms.com

R. D. McQuade

Otsuka America Pharmaceutical, Princeton, New Jersey, USA

EDITED BY KIRIAKOS XENITIDIS and COLIN CAMPBELL

Declaration of interest

G.A.S. and R.G.-E are employees of Bristol-Myers Squibb. R.D.M. is an employee of Otsuka Pharmaceutical Development and Commercialization Inc.

El-Sayeh et al (2006) raise some important issues regarding the design and reporting of clinical trials. However, we feel that the conclusion that `aripiprazole has been licensed despite the fact that few reliable data on this drug are publicly available' merits further clarification. Aripiprazole was first approved in November 2002 in the USA, and in 2004 in Europe, based on the submission of a substantial body of evidence to the regulatory authorities on more than 4000 patients. However, Bristol-Myers Squibb and Otsuka Pharmaceuticals are committed to reporting trial results as completely as possible, and publication of pivotal studies has taken place subsequent to approval.

All the aripiprazole clinical studies were conducted in accordance with regulatory requirements and using accepted standards (Marder et al, 2003; Naber & Lambert, 2004). Such studies have inherent restrictions, and we recognise that patients enrolled may not always reflect those seen in everyday care. We understand the value of all study types - randomised controlled trials, naturalistic, retrospective, observational - in helping to determine the benefit-risk profile, and have recently completed a series of studies with more naturalistic designs and with large sample sizes, to explore the benefits in a wide range of patients (Tandon et al, 2006; Kerwin et al, 2007, details of the other study can be obtained from http://www.clinicaltrials.gov, trial number NCT00237939). These complete studies support the profile of aripiprazole established in the clinical studies reviewed by El-Sayeh et al in their systematic analysis.

With respect to the suggestion that deaths occurring during the aripiprazole studies have not been widely reported, it is our practice to report any deaths or adverse events applicable to a study and we have done so consistently in our publications. Deaths unfortunately do occur during studies, just as they do in real-world situations.

We are committed to continued openness and disclosure of clinical study results, and as such will continue to work closely with El-Sayeh et al.

REFERENCES

El-Sayeh, H. G., Morganti, C. & Adams, C. E. (2006) Aripiprazole for schizophrenia. Systematic review. British Journal of Psychiatry, 189, 102 -108.[Abstract/Free Full Text]

Kerwin, R., Millet, B., Herman, E., et al (2007) A multicentre, randomized naturalistic open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients. Schizophrenia Trial of Aripiprazole (STAR Study). European Psychiatry, in press.

Marder, S. R., McQuade, R. D., Stock, E., et al (2003) Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials. Schizophrenia Research, 61, 123 -136.[CrossRef][Medline]

Naber, D. & Lambert, M. (2004) Aripiprazole: a new atypical antipsychotic with a different pharmacological mechanism. Progress in Neuropsychopharmacology and Biological Psychiatry, 28, 1218 -1219.

Tandon, R., Marcus, R. N., Stock, E. G., et al (2006) A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial with Aripiprazole (BETA). Schizophrenia Research, 84, 77-89.[CrossRef][Medline]





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