Risperidone Versus Conventional Antipsychotics for Schizophrenia
Risperidone Versus Conventional Antipsychotics for Schizophrenia
Objective: To prospectively compare risperidone with conventional antipsychotic agents among schizophrenia patients treated under usual practice conditions.
Design: One-year, multicentre, open-label, randomised trial carried out in 21 centres in 17 states of the US.
Patients: 684 patients were followed from 1995 to 1997, and must have experienced a symptom relapse at study start.
Interventions: Patients were randomly assigned to risperidone therapy or their physician's 'best choice' of any one of the 13 conventional antipsychotic medications approved in the US.
Main Outcome Measures and Results: Outcomes measured were changes in psychiatric symptoms, side effects, satisfaction with drug therapy, quality of life (including health-related quality of life [HRQOL]) and resource utilisation. A subgroup analysis of the non-switchers was also conducted. Irrespective of treatment group, treatment switching and days with no drug therapy were observed. Compared with patients on conventional antipsychotics, those in the risperidone group achieved statistically superior scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [PANSS total score improved from 83.32 to 61.80 vs 81.42 to 66.99 in the risperidone and conventional groups, respectively), Barnes Akathisia Scale (scores improved from 0.89 to 0.55 vs 0.87 to 0.81 in the risperidone and conventional groups, respectively), and 36-Item Short Form Health Survey (SF-36) scale (scores improved from 32.83 to 39.92 vs 32.55 to 37.22 in the risperidone and conventional groups, respectively) during the 1-year treatment period. A significantly higher percentage of risperidone- treated patients had a 60% improvement in PANSS scores at 12 months (20.9% of patients compared with 10.7% in the risperidone and conventional groups, respectively). There was no statistically significant difference in resource utilisation between the two groups. Among non-switchers, patients in the risperidone group had lower total costs and more clinical benefits.
Conclusions: Conditions of usual practice resulted in a high degree of non-treatment, treatment changing and multi-antipsychotic drug therapy. Patients in the risperidone group had better clinical outcomes (e.g. reduced psychiatric symptoms and side effects) and improved HRQOL. There were no significant differences in healthcare utilisation between the two study groups.
Schizophrenia is a burdensome condition that affects approximately 1% of the US population, with many persons diagnosed with schizophrenia having poor outcomes such as relapse, rehospitalisation and social dysfunction. Antipsychotic agents form the foundation of treatment for patients with schizophrenia. The efficacy of treatment with traditionally available dopamine antagonist (conventional) antipsychotics such as haloperidol and chlorpromazine is well established, but these medications provide insufficient benefit to a large number of schizophrenia patients and are associated with side effects such as sedation. Furthermore, the negative symptoms of schizophrenia (e.g. emotional withdrawal, poor rapport, passive/apathetic social withdrawal, and difficulty in abstract thinking) are often resistant to treatment with conventional antipsychotics. The atypical antipsychotic agents that became available in the 1990s have a substantially improved side effect profile compared with conventional agents. Atypical agents have also demonstrated improved efficacy in the treatment of schizophrenia and reduced risk of relapse.
Schizophrenia is associated with serious problems concerning the continuity and consistency of mental healthcare and the failure to optimise medication therapy, which contribute to problems with compliance and suboptimal treatment outcomes. Agents that could improve medication therapy and optimise treatment outcomes have the potential to improve the standard of care provided to patients with schizophrenia. However, many studies designed to investigate the effects of antipsychotic agents on treatment outcome are studies of controlled treatment, such as clinical trials for product registration, and these may not accurately reflect the outcomes of care that community patients and providers may expect. However, two recently published naturalistic studies have demonstrated that atypical agents may provide the opportunity to improve treatment outcomes in patients switched from conventional agents to atypical agents demonstrating improved treatment compliance, psychosocial functioning and quality of life. Thus, the objective of this study was to investigate whether, under conditions of usual practice, administration of risperidone instead of a conventional antipsychotic agent after a relapse of schizophrenia results in improved patient outcomes.
Objective: To prospectively compare risperidone with conventional antipsychotic agents among schizophrenia patients treated under usual practice conditions.
Design: One-year, multicentre, open-label, randomised trial carried out in 21 centres in 17 states of the US.
Patients: 684 patients were followed from 1995 to 1997, and must have experienced a symptom relapse at study start.
Interventions: Patients were randomly assigned to risperidone therapy or their physician's 'best choice' of any one of the 13 conventional antipsychotic medications approved in the US.
Main Outcome Measures and Results: Outcomes measured were changes in psychiatric symptoms, side effects, satisfaction with drug therapy, quality of life (including health-related quality of life [HRQOL]) and resource utilisation. A subgroup analysis of the non-switchers was also conducted. Irrespective of treatment group, treatment switching and days with no drug therapy were observed. Compared with patients on conventional antipsychotics, those in the risperidone group achieved statistically superior scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [PANSS total score improved from 83.32 to 61.80 vs 81.42 to 66.99 in the risperidone and conventional groups, respectively), Barnes Akathisia Scale (scores improved from 0.89 to 0.55 vs 0.87 to 0.81 in the risperidone and conventional groups, respectively), and 36-Item Short Form Health Survey (SF-36) scale (scores improved from 32.83 to 39.92 vs 32.55 to 37.22 in the risperidone and conventional groups, respectively) during the 1-year treatment period. A significantly higher percentage of risperidone- treated patients had a 60% improvement in PANSS scores at 12 months (20.9% of patients compared with 10.7% in the risperidone and conventional groups, respectively). There was no statistically significant difference in resource utilisation between the two groups. Among non-switchers, patients in the risperidone group had lower total costs and more clinical benefits.
Conclusions: Conditions of usual practice resulted in a high degree of non-treatment, treatment changing and multi-antipsychotic drug therapy. Patients in the risperidone group had better clinical outcomes (e.g. reduced psychiatric symptoms and side effects) and improved HRQOL. There were no significant differences in healthcare utilisation between the two study groups.
Schizophrenia is a burdensome condition that affects approximately 1% of the US population, with many persons diagnosed with schizophrenia having poor outcomes such as relapse, rehospitalisation and social dysfunction. Antipsychotic agents form the foundation of treatment for patients with schizophrenia. The efficacy of treatment with traditionally available dopamine antagonist (conventional) antipsychotics such as haloperidol and chlorpromazine is well established, but these medications provide insufficient benefit to a large number of schizophrenia patients and are associated with side effects such as sedation. Furthermore, the negative symptoms of schizophrenia (e.g. emotional withdrawal, poor rapport, passive/apathetic social withdrawal, and difficulty in abstract thinking) are often resistant to treatment with conventional antipsychotics. The atypical antipsychotic agents that became available in the 1990s have a substantially improved side effect profile compared with conventional agents. Atypical agents have also demonstrated improved efficacy in the treatment of schizophrenia and reduced risk of relapse.
Schizophrenia is associated with serious problems concerning the continuity and consistency of mental healthcare and the failure to optimise medication therapy, which contribute to problems with compliance and suboptimal treatment outcomes. Agents that could improve medication therapy and optimise treatment outcomes have the potential to improve the standard of care provided to patients with schizophrenia. However, many studies designed to investigate the effects of antipsychotic agents on treatment outcome are studies of controlled treatment, such as clinical trials for product registration, and these may not accurately reflect the outcomes of care that community patients and providers may expect. However, two recently published naturalistic studies have demonstrated that atypical agents may provide the opportunity to improve treatment outcomes in patients switched from conventional agents to atypical agents demonstrating improved treatment compliance, psychosocial functioning and quality of life. Thus, the objective of this study was to investigate whether, under conditions of usual practice, administration of risperidone instead of a conventional antipsychotic agent after a relapse of schizophrenia results in improved patient outcomes.