Electronic Letters to:
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eLetters: Electronic letters published:
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Aripiprazole for Schizophrenia, El-Sayeh et al British Journal of Psychiatry 2006;189:102–108.
- Gabrielle A Silver, Rolando Gutierrez-Esteinou, and Robert McQuade (22 August 2006)
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Gabrielle A Silver, Therapeutic Area Director Neuroscience Bristol-Myers Squibb Company, Uxbridge, UK, Rolando Gutierrez-Esteinou, and Robert McQuade
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gabrielle.silver{at}bms.com Gabrielle A Silver, et al.
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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 on this 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 taken place 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; Wolf et 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 which can 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 authors of 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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