Use of Risperdal Consta® (Injection) and Risperdal Oral for Treatment of Schizophrenia, 2 Studies

Main Category: Schizophrenia
Article Date: 27 May 2005 - 13:00 PDT

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A two year European-wide study involving 1876 patients published for the first time in this month's INTERNATIONAL JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, showed that people with schizophrenia who changed their antipsychotic treatment to Risperdal Consta experienced significant improvements in symptoms, health-related quality of life and patient satisfaction, regardless of the severity of symptoms at the start of the study.1

These findings are the results for the pan-European, open, single-arm "StoRMi" study* which concluded that Risperdal Consta is effective and well tolerated, providing an advance in the treatment options for a wide range of patients requiring long-term antipsychotic therapy.

"This exciting new data shows the real advantage of Risperdal Consta in terms of long-term patient benefit, as an alternative option to other antipsychotic medications, enabling patients to manage their symptoms effectively. With the appropriate education and support within an overall package of care, patients could have a greater chance of resuming their normal lives and avoiding the distressing effects of relapse if they change to Risperdal Consta," said Dr Stephen D Martin from Durham who was one of the lead authors of the primary manuscript.

Nearly two thirds of the 1876 patients hospitalised at the start of this study were able to return to the community after treatment with Risperdal Consta, with only 3% of patients withdrawing from treatment with Risperdal Consta due to poor compliance. The most frequent reasons for changing to Risperdal Consta were non-compliance (38%), insufficient efficacy (33%) and side effects (26%).

Assessment of patients using the Positive and Negative Syndrome Scale (PANSS)** found that people experiencing symptoms on their existing conventional or atypical antipsychotic therapies, showed significant improvement over the course of six months after changing to Risperdal Consta, with clear improvement apparent after only one month. Risperdal Consta is the only atypical antipsychotic available in the UK as a long-acting injection.

Current opinion is that the management of people with schizophrenia should extend beyond symptom control and include the prevention of relapse, improvement in patients' overall functioning and quality of life.2 One of the key challenges in the treatment of schizophrenia is encouraging patients to keep taking their medication, because stopping medication can lead to relapse.3

Risperdal oral study

Another two year study published in the American Journal of Psychiatry this month showed that when treated with oral Risperdal early in psychotic illness, patients were less likely to relapse and were relapse-free for longer, compared with haloperidol. 4 The first episode of psychotic illness is a key intervention point since half of patients experience relapse within a year.5 If people have had a positive experience of medication they are more likely to be able to take treatment long term, therefore reducing the risk of another episode.

This was the longest such trial comparing conventional antipsychotic medication and an atypical agent, demonstrating a clear advantage of Risperdal in terms of relapse prevention and reduced incidence of symptoms and side effects such as movement disorders. This supports the guidance issued by the National Institute for Clinical Excellence which recommends the use of atypical antipsychotics as first-line treatments in people with newly diagnosed schizophrenia.6

"A positive response and experience with medication is vital from the start in schizophrenia if it is to improve patients' long-term prognosis and thus quality of life. These data provide reassuring support for the initiation of atypical antipsychotics for patients at the all important stage of the first episode stage. Risperdal demonstrates a good efficacy and side-effect profile, significantly reducing the chance of relapse and the distressing abnormal movements associated with the conventional antipsychotics," said Dr Paddy Power, London.

The study (looking at 555 patients from 11 countries) demonstrated that early initiation of oral Risperdal in first episode psychosis induced significantly fewer abnormal movements than haloperidol, adding to the already extensive package of data in support of first-line Risperdal therapy. The data also indicated no significant difference in weight gain between the two treatments at the end of the study.

*This was a non-randomised, single arm study, performed at 324 centres in 22 European countries between December 2001 and March 2004. Patients with schizophrenia or other psychotic disorders treated with any antipsychotic medication, and who required a change of medication for any reason, were transitioned directly from their previous antipsychotic medication to Risperdal Long Acting Injectable (RLAI) without an oral risperidone run-in.

Patients symptomatically stable, but considered to require a treatment change, received 25 mg RLAI (increased to 37.5 or 50 mg, if necessary) every 2 weeks for 6 months. Assessments included Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) - Severity, Global Assessment of Functioning (GAF), SF-36 Health Related Quality of Life Questionnaire and Extrapyramidal (movement) Symptoms Rating Scale.

**At baseline, the PANSS score for the total population was 73.4±22.3 (range 30-158) and this was reduced at endpoint (63.1±22.8, range 30-151; p<0.001).

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

Janssen-Cilag Ltd (www.janssen-cilag.co.uk), manufacturer of Risperdal® Consta™ (http://www.risperdal-consta.co.uk), Risperdal™ (risperidone) and Risperdal® Quicklet™ 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.

References:

1. Moller HJ et al. Efficacy and Safety of Direct Transition to Risperidone Long-Acting Injectable in Patients Treated with Various Antipsychotic Therapies. International Clinical
Psychopharmacology, May 2005, Volume 20, (3):121-130.

2. Kane, J. Progress defined - short-term efficacy, long-term effectiveness. International Clinical Psychopharmacology, 2001, 16(suppl 1):S1-S8.

3. Oehl M et al. Compliance with antipsychotic treatment. Acta Psychiatr Scand, 2000, 102(suppl 407):83-86.

4. Schooler N et al. Risperidone and Haloperidol in First-Episode Psychosis: A Long-Term Randomized Trial. Am J Psychiatry, May 2005, 162:1-7.

5. Robinson D et al. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder. Arch Gen Psychiatry, March 1999, 56:241-247.

6. The National Institute for Clinical Excellence. Guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia, June 2002.