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Aripiprazole for schizophrenia: Systematic review

  • H. G. El-Sayeh (a1), C. Morganti (a2) and C. E. Adams (a1)

Abstract

Background

Aripiprazole is an atypical antipsychotic that is reported to be effective in the treatment of schizophrenia.

Aims

To investigate the effects of aripiprazole on patients with schizophrenia and schizophrenia-like psychoses by conducting a systematic review of randomised controlled trials (RCTs).

Method

Database and manual searches and direct contact were used to identify relevant RCTs.

Results

We included 10 randomised controlled studies (involving a total of 4125 patients), but study attrition was large and the standard of data reporting was poor. Compared with placebo, aripiprazole treatment was associated with a significant decrease in relapse rates, increased compliance with the study protocol, and a decrease in prolactin levels below the expected values. Compared with risperidone, aripiprazole caused less elevation of prolactin levels and less prolongation of the average QTc interval.

Conclusions

Aripiprazole has been licensed despite the fact that few reliable data on this drug are publicly available. It may be effective for treatment of schizophrenia, but in terms of tolerability and global outcomes it shows little difference from existing antipsychotics.

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Copyright

Corresponding author

Dr H. G. El-Sayeh, Briary Wing, Harrogate District Hospital, Lancaster Park Road, Harrogate HG2 7SX, UK. Tel: +44 (0)1423 553 682; fax: +44 (0)1423 553 379; email: hany.el-sayeh@chrd-pct.nhs.uk

Footnotes

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Declaration of interest

None. Funding detailed in Acknowledgements.

Footnotes

References

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Aripiprazole for schizophrenia: Systematic review

  • H. G. El-Sayeh (a1), C. Morganti (a2) and C. E. Adams (a1)
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eLetters

Aripiprazole for Schizophrenia, El-Sayeh et al British Journal of Psychiatry 2006;189:102�108.

Gabrielle A Silver, Therapeutic Area Director Neuroscience
22 August 2006

Sir,

We thank you for raising some important issues regarding the design and reporting of clinical trials. However, we feel that the conclusion “Aripiprazole has been licensed despite the fact that few reliable data onthis drug are publicly available” merits further clarification. Aripiprazole was first approved in November 2002 in the US, and in Europe in 2004, based on the submission of a substantial body of evidence to the regulatory authorities, totaling in excess of 4000 aripiprazole-treated patients. However, BMS/Otsuka are committed to reporting trial results as completely as possible, and publication of these pivotal studies has takenplace subsequent to approval.

All the aripiprazole clinical studies were conducted in accordance with regulatory requirements and using accepted standards. Such studies have inherent restrictions, and we recognize that the patients enrolled may not always reflect those seen in everyday care. We understand the value of all study types – RCTs, naturalistic, retrospective, observational – in helping to determine the benefit–risk profile of this antipsychotic and, as such, have recently completed a series of studies with more naturalistic designs, with large sample sizes, to explore the benefits of aripiprazole in a wider range of patients (STAR, N=555; US-BETA, N=1599; EU-BETA, N=833) (Banki et al, 2006; Tandon et al, 2006; Wolfet al, 2006). These studies present data on ‘real-life’ outcomes, including time to discontinuation, preference of medication, and quality of life, and the full articles are in submission. These completed studies support the profile of aripiprazole established in the clinical studies reviewed in your systematic analysis. Additionally, a number of ongoing studies are underway to further explore aripiprazole use, details of whichcan be found in the publicly-accessible trials registry at www.clinicaltrials.gov.

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

We are committed to continued openness and disclosure of clinical study results, and as such, will continue to work closely with the authorsof this systematic review.

Gabrielle A Silver1 (BSc, MB BS MFPM); Rolando Gutierrez-Esteinou MD2, Robert McQuade PhD3

1 Bristol-Myers Squibb Company, Uxbridge, UK; 2 Bristol-Myers Squibb Company, Princeton, USA; 3 Otsuka America Pharmaceutical Inc., Princeton, NJ, USA

Word count: 358 words (350 permitted)

Gabrielle A Silver and Rolando Gutierrez-Esteinou are employees of Bristol-Myers Squibb Company. Robert McQuade is an employee of Otsuka America Pharmaceutical Inc.
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Conflict of interest: None Declared

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