Schizophrenia - First Head-To-Head Trial Of Oral Zyprexa Vs. Risperdal Consta (Risperidone Long-Acting Injection)

Main Category: Schizophrenia
Also Included In: Psychology / Psychiatry;  Clinical Trials / Drug Trials
Article Date: 13 Aug 2007 - 0:00 PDT

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Newly-published data in the latest edition of the British Journal of Psychiatry (August 2007) show that patients receiving risperidone long-acting injection (Risperdal® ConstaTM) experienced a higher incidence of significant clinical improvements, as well as greater improvements in measures of disorganised thinking at 12 months than patients taking oral olanzapine (Zyprexa)1.

The data, from the first randomised, controlled, open label head-to-head study showed that both treatments were efficacious and generally well-tolerated1. The efficacy results suggested that in the long-term patients might benefit more from treatment with long-acting risperidone injection than with oral olanzapine1.

The study recruited patients at 48 centres worldwide including the UK1. A total of 318 patients were randomised to long-acting risperidone injection and 300 to olanzapine of which 160 and 187 patients, respectively, completed the 12-month trial1. The primary measure of efficacy was the change in total score on the Positive and Negative Syndrome Scale (PANSS) from base-line to end-point for both short-term (13 weeks) and long-term (12 months) outcomes1.

Risperidone long-acting injection achieved clinical improvements (20% minimum reduction in PANSS total scores) in significantly more patients (91% vs. 79%; P<0.001) compared with olanzapine at 12 months1.

At the trial's long term end-point (12 months), a significantly greater improvement on one PANSS factor score (disorganised thoughts) was seen in patients receiving long-acting risperidone than in those receiving olanzapine1. Improvements in disorganised thinking are viewed as important because this is one of the barriers to people living with schizophrenia functioning on a day-to-day basis. Significantly greater improvements were seen in anxiety/depression in the olanzapine group1.

The trial data also suggest that long-acting risperidone may have a less pronounced effect on weight gain and body mass index (BMI) than olanzapine1. The mean weight gain change in the long-acting risperidone group was 1.7kg compared to 4.0kg in the olanzapine group at the study end-point (P<0.05) and BMI was 0.6kg/m2 compared to 1.4kg/m2, respectively (P<0.05)1.

Sexually-related side-effects were reported by 3% of the patients in each group1. Severity of adverse events relating to movement disorders was mild in both groups1, although these events were more frequent (25%) in the RLAI group than in the olanzapine group (15%)1. Five patients discontinued treatment (for any reason) in the olanzapine group compared to only one in the risperidone group1.

The study was supported by Johnson & Johnson Pharmaceutical Research and Development who also completed the statistical analysis.

Janssen-Cilag Ltd (http://www.janssen-cilag.co.uk), manufacturer of Risperdal® Consta™ (http://www.risperdal-consta.co.uk), Risperdal™ (risperidone), Risperdal® Quicklet™ and Invega® is part of the Johnson & Johnson family of companies, a leading research-based pharmaceutical company, with more than 110,000 employees worldwide and establishments in approximately 50 countries.

Symptoms of schizophrenia include hearing voices, hallucinations and delusions, apathy, social withdrawal and a lack of emotional expression.

Reference:
1. Keks, N.A., Ingham,M., Khan,A., & Karcher,K. Long-acting injectable risperidone v. olanzapine tablets for schizophrenia or schizoaffective disorder: Randomised, controlled, open-label study. Br. J. Psychiatry 191, 131-139 (2007).

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