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Long-acting injectable risperidone v. olanzapine tablets for schizophrenia or schizoaffective disorder: Randomised, controlled, open-label study

  • Nicholas A. Keks (a1), Michael Ingham (a2), Akbar Khan (a2) and Keith Karcher (a2)
Abstract
Background

The efficacy and safety of long-acting injectable risperidone have not been compared with those of an oral atypical antipsychotic.

Aims

To compare long-acting risperidone and oral olanzapine in 377 patients with DSM–IV schizophrenia or schizoaffective disorder.

Method

Patients were randomised to receive long-acting risperidone (25 mg or 50 mg every 14 days) or olanzapine (5–20 mg/day).

Results

In the 13-week phase, long-acting risperidone was at least as effective as (not inferior to) oral olanzapine. In the 12-month phase, significant improvements in the Positive and Negative Syndrome Scale (PANSS) total and factor scores from baseline to month 12 and end-point were seen in both groups of patients. Few patients discontinued treatment because of an adverse event.

Conclusions

Both treatments were efficacious and well tolerated.

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Copyright
Corresponding author
Professor Nicholas A. Keks, Delmont Hospital, 298 Warrigal Road, Glen Iris, VIC 3146, Australia. Email: Nicholas.keks@med.monash.edu.au
Footnotes
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Declaration of interest

N. K. has received support fromor been a consultant for Astra Zeneca, Bristol- Meyers Squibb, Janssen Pharmaceutica, Eli Lilly, Sanofi-Synthelabo, Pfizer and Wyeth. M. I., A. K. and K. K. are employees of Johnson & Johnson.

Footnotes
References
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Long-acting injectable risperidone v. olanzapine tablets for schizophrenia or schizoaffective disorder: Randomised, controlled, open-label study

  • Nicholas A. Keks (a1), Michael Ingham (a2), Akbar Khan (a2) and Keith Karcher (a2)
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eLetters

Long acting injectable risperidone v olanzapine.

Satish K Karunakaran, Consultant Psychiatrist
31 October 2007

Sir / Madam,Keks et al (2007) reports that patients with schizophrenia or schizoaffective disorders might benefit more, in the long term, from treatment with long acting injectable risperidone than with oral olanzapine. For assessing long term efficacy they compared 155 patients who received injectable risperidone with 207 patients who received oral olanzapine, and found that more patients in the risperidone group attained20% reduction in PANNS total scores. This result can only be accepted if compliance rates in both the groups were comparable. Risperidone group, with medication administered as injections, presumably had 100% compliance, excepting those who discontinued due to serious adverse events. Authors claim that compliance in the oral olanzapine group was comparable (mean time off drug, per patient, was 0.7 days, over 12 months). It is not clear how they established this remarkable compliance. Self reporting of compliance can be notoriously inaccurate (Velligan, D.L., et al., 2007). Self reporting may be acceptable where both the experimental and the control group are on oral medication, but it affects the validity of the study when one group gets injectables. Most studies show that compliance with oral antipsychotic medications, even for supposedly better tolerated atypicals, is only about 50% (Dolder, C.R., etal., 2003). In the CATIE trial (Leiberman, J.A., et al., 2005) more than 60% of patients on olanzapine, the medication that had the highest rate ofcompliance in that study, discontinued their medications over a period of 18 months. If one assumes similar compliance rates in the present study, then the authors’ claim of superior efficacy does not hold. In fact it would appear that a group of patients on olanzapine with 50% compliance had comparable outcomes with a group on injectable medications with nearly100% compliance. Moreover, it is not clear how many patients on the injectable risperidone were under a legal obligation and did not have any choice about discontinuing their medications compared to those on oral medications. This can also affect relative levels of compliance.

Declaration of interest: I have attended local educational meetings organised by Ely Lilly and Jansen Cilag.

References:Dolder, C.R., Lacro, J.P., Leckband, S., et al. (2003) Interventions to improve antipsychotic medication adherence: Review of recent literature. Journal of Clinical Psychopharmacology 23, 389-399.

Keks NA, Ingham M, Khan A, et al (2007) Long acting injectable risperidone v. Olanzapine tablets for schizophrenia or schizoaffective disorder. British Journal of Psychiatry, 191, 131-139.

Leiberman, J.A., Stroup, T.S., McEvoy, J.P., et al. (2005) Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine 353, 1209-23.

Velligan, D.I., Wang, M., Diamond, P., et al. (2007) Relationships among subjective and objective measures of adherence to oral antipsychoticmedications. Psychiatric Services, Sep 58 (9), 1187-92.
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Conflict of interest: None Declared

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