- Email: [email protected]
Guidelines adherence in treated schizophrenic patients
18. Therapeutics: Treatment Trials
283
GUIDELINES ADHERENCE IN TREATED SCHIZOPHRENIC PATIENTS I. Fernandez,* M. D e Hert, M. Wampers, E. Thys, S. Wyckaert, J. Peuskens Psychosis Units, UC St Jozef Kortenberg, Vlaams Brabant, Belgium Antipsychotic medication is the cornerstone in the treatment of schizophrenia. Despite the effectiveness to combat psychotic symptoms of typical and atypical antipsychotics, patient compliance is often far from optimal. Multiple factors contribute to this lack of treatment adherence (side-effects, inadequate dosing, complicated schemes, ...). Different treatment guidelines have been published. We extracted testable guideline statements and applied them on a naturalistic data-set of treated schizophrenic patients in Belgium. In this prospective study over 1200 patients are being followed for more than 3 years. Patients are assessed with PECC (Psychosis Evaluation tool for Common use by Caregivers, De Hert et al., 1999 and 2002). PECC assesses, amongst others, different clinical outcome measures, side-effects and current pharmacological treatment. Results indicate that polypharmacy is frequent and that medication schemes are often complex. Patients take on average 3.7 different drugs of which 3.3 different psychotropic agents. The majority of patients are on monotherapy of either typical (30.7%) or atypical (41.5%) antipsychotics. Another 27.8% combines typical and atypical drugs. Within this group, 35% of patients receive a sedative antipsychotic in combination with an atypical. The average dose of atypicals is 5.3 mg risperidone-equivalents. For typical agents the average dose is 7.4 mg haloperidol-equivalents. Patients started for the first time on an antipsychotic remain significantly more on an atypical (70%) than on a classical antipsychotic (49%). On average patients stay 4 months on a drug before a switch to another antipsychotic is made. Other medications used by patients are : benzodiazepines (57%), antidepressants and mood-stabilisers (45%), anticholinergics (37%) and somatic drugs (34%). Patients on monotherapy atypicals need significantly less anticholinergics (20%) than patients on monotherapy of classical antipsychotics (56%). The EPS advantage of atypicals is also lost in the group who uses both types of antipsychotics, 49% of them need an anticholinergic agent. Apart from the frequent combination of drugs most guidelines are being followed by Belgian clinicians. Atypical antipsychotics have a high penetration, nearly 70% of patients. The frequent polypharmacy motivates further efforts to obtain more transparancy and simplicity in medication use.
R A N D O M I Z E D A S S E S S M E N T OF STRATEGIES FOR SWITCHING PATIENTS WITH SUBOPTIMAL TREATMENT OUTCOMES FROM OLANZAPINE TO RISPERIDONE R. Ganguli,* S. Berry, G. Gharabawi, C. Lonchena, R. M a h m o u d , J. Brat, G. Pandina UPMC Health System, Western Psychiatric Institute & Clinic, Pittsburgh, PA, USA Because many patients (pts) may not respond to or tolerate their antipsychotic treatment, clinicians need defined, data-driven guidance for switching antipsychotic medications. This study compares different strategies for switching pts with suboptimal treatment outcomes from olanzapine (OLANZ) to risperidone (RIS). Phase 1 of a randomized, open-label, rater-blinded switching study was conducted in pts with schizophrenia or schizoaffective disorder. Patients intolerant of or exhibiting a suboptimal response to OLANZ were
randomly assigned to one of three switching paradigms (Abrupt, Gradual 1 or Gradual 2) and followed for 6 weeks. The Abrupt paradigm had no overlap of RIS and OLANZ. OLANZ was continued for 1 week after RIS initiation in the Gradual 1 (50% reduction in OLANZ while titrating RIS) and Gradual 2 strategies (100% of OLANZ dose for 1 week while titrating RIS, reducing to 50% for 1 week, then discontinuation). Of the 123 pts enrolled, 95 (78.5%) completed. Discontinuations were as follows, Abrupt =10 pts (25.0%), Gradual 1 =11 pts (28.2%), Gradual 2 =5 pts (11.9%). The most common reasons for discontinuation in the 3 groups were adverse events (5%, 15.4%, 4.8%, respectively) and withdrawal of consent (10%, 7.7%, 0%, respectively). Mean OLANZ dose at entry was 15.5 mg/d. Mean-modal RIS dose, following the switch, was 4.3 mg/d. Adverse events reported in >10% ofpts in any strategy included insomnia, anxiety, sedation, somnolence, headache, and psychosis (aggravated), with some difference between groups favoring the Gradual 2 strategy. A switch to RIS was associated with significant improvement in overall psychopathology (PANSS total score; p<0.0001) and general psychopathology (p=0.001) and positive symptom (p<0.0001) subscales. Our results indicate that patients with suboptimal response to olanzapine may improve after being switched to risperidone. All three switching strategies appear to be safe and effective overall. However, potential withdrawal symptoms might accompany stopping olanzapine. Hence, tapering of this drug, after initiation of risperidone, might still be the prudent course of action.
CHANGE IN CLINICAL STATUS AND SIDE EFFECTS OF PATIENTS TREATED WITH EITHER OLANZAPINE OR RISPERIDONE: SIXMONTH RESULTS FROM THE THREE-YEAR INTERCONTINENTAL SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES (IC-SOHO) OBSERVATIONAL STUDY R R. Gargoloff,* R. A. O'Halloran, J. M. Boland, E. Brunner, M. Dossenbach, L. Levitt, A. Valencia, E. Landa, C. GonzNez Clfnica City Bell, La Plata, Argentina Objective: To compare the 6-month change in clinical status and incidence of side effects in patients who initiated or changed to either olanzapine or risperidone antipsychotic treatment at baseline. Method: This is a 3-year, prospective intercontinental observational study of the health outcomes associated with antipsychotic therapy in outpatients with schizophrenia. Patients were enrolled if, at the discretion of the treating psychiatrist, they initiated or changed antipsychotic medication. There are two principle cohorts: initiated or changed to olanzapine treatment (1), initiated or changed to nonolanzapine treatment (2). Here we report how patients that were prescribed either olanzapine or risperidone at baseline have progressed after 6 months of treatment. Results: A total of 7655 patients across 27 countries in the intercontinental region were included in this study. Overall, 51% of patients were prescribed olanzapine, 20% risperidone. Olanzapine-treated patients improved significantly (p<0.0001) with respect to overall, positive, negative, depressive, and cognitive symptoms (Table 1). Patients prescribed olanzapine had a greater improvement in the severity of tardive dyskinesia (p=0.0445) and a significantly greater improvement in the severity of extrapyramidal symptoms (p<0.000l) compared to risperidonetreated patients. Furthermore, at 6 months risperidone-treated patients were prescribed anticholinergic medications significantly
International Congress on Schizophrenia Research 2003
283
GUIDELINES ADHERENCE IN TREATED SCHIZOPHRENIC PATIENTS I. Fernandez,* M. D e Hert, M. Wampers, E. Thys, S. Wyckaert, J. Peuskens Psychosis Units, UC St Jozef Kortenberg, Vlaams Brabant, Belgium Antipsychotic medication is the cornerstone in the treatment of schizophrenia. Despite the effectiveness to combat psychotic symptoms of typical and atypical antipsychotics, patient compliance is often far from optimal. Multiple factors contribute to this lack of treatment adherence (side-effects, inadequate dosing, complicated schemes, ...). Different treatment guidelines have been published. We extracted testable guideline statements and applied them on a naturalistic data-set of treated schizophrenic patients in Belgium. In this prospective study over 1200 patients are being followed for more than 3 years. Patients are assessed with PECC (Psychosis Evaluation tool for Common use by Caregivers, De Hert et al., 1999 and 2002). PECC assesses, amongst others, different clinical outcome measures, side-effects and current pharmacological treatment. Results indicate that polypharmacy is frequent and that medication schemes are often complex. Patients take on average 3.7 different drugs of which 3.3 different psychotropic agents. The majority of patients are on monotherapy of either typical (30.7%) or atypical (41.5%) antipsychotics. Another 27.8% combines typical and atypical drugs. Within this group, 35% of patients receive a sedative antipsychotic in combination with an atypical. The average dose of atypicals is 5.3 mg risperidone-equivalents. For typical agents the average dose is 7.4 mg haloperidol-equivalents. Patients started for the first time on an antipsychotic remain significantly more on an atypical (70%) than on a classical antipsychotic (49%). On average patients stay 4 months on a drug before a switch to another antipsychotic is made. Other medications used by patients are : benzodiazepines (57%), antidepressants and mood-stabilisers (45%), anticholinergics (37%) and somatic drugs (34%). Patients on monotherapy atypicals need significantly less anticholinergics (20%) than patients on monotherapy of classical antipsychotics (56%). The EPS advantage of atypicals is also lost in the group who uses both types of antipsychotics, 49% of them need an anticholinergic agent. Apart from the frequent combination of drugs most guidelines are being followed by Belgian clinicians. Atypical antipsychotics have a high penetration, nearly 70% of patients. The frequent polypharmacy motivates further efforts to obtain more transparancy and simplicity in medication use.
R A N D O M I Z E D A S S E S S M E N T OF STRATEGIES FOR SWITCHING PATIENTS WITH SUBOPTIMAL TREATMENT OUTCOMES FROM OLANZAPINE TO RISPERIDONE R. Ganguli,* S. Berry, G. Gharabawi, C. Lonchena, R. M a h m o u d , J. Brat, G. Pandina UPMC Health System, Western Psychiatric Institute & Clinic, Pittsburgh, PA, USA Because many patients (pts) may not respond to or tolerate their antipsychotic treatment, clinicians need defined, data-driven guidance for switching antipsychotic medications. This study compares different strategies for switching pts with suboptimal treatment outcomes from olanzapine (OLANZ) to risperidone (RIS). Phase 1 of a randomized, open-label, rater-blinded switching study was conducted in pts with schizophrenia or schizoaffective disorder. Patients intolerant of or exhibiting a suboptimal response to OLANZ were
randomly assigned to one of three switching paradigms (Abrupt, Gradual 1 or Gradual 2) and followed for 6 weeks. The Abrupt paradigm had no overlap of RIS and OLANZ. OLANZ was continued for 1 week after RIS initiation in the Gradual 1 (50% reduction in OLANZ while titrating RIS) and Gradual 2 strategies (100% of OLANZ dose for 1 week while titrating RIS, reducing to 50% for 1 week, then discontinuation). Of the 123 pts enrolled, 95 (78.5%) completed. Discontinuations were as follows, Abrupt =10 pts (25.0%), Gradual 1 =11 pts (28.2%), Gradual 2 =5 pts (11.9%). The most common reasons for discontinuation in the 3 groups were adverse events (5%, 15.4%, 4.8%, respectively) and withdrawal of consent (10%, 7.7%, 0%, respectively). Mean OLANZ dose at entry was 15.5 mg/d. Mean-modal RIS dose, following the switch, was 4.3 mg/d. Adverse events reported in >10% ofpts in any strategy included insomnia, anxiety, sedation, somnolence, headache, and psychosis (aggravated), with some difference between groups favoring the Gradual 2 strategy. A switch to RIS was associated with significant improvement in overall psychopathology (PANSS total score; p<0.0001) and general psychopathology (p=0.001) and positive symptom (p<0.0001) subscales. Our results indicate that patients with suboptimal response to olanzapine may improve after being switched to risperidone. All three switching strategies appear to be safe and effective overall. However, potential withdrawal symptoms might accompany stopping olanzapine. Hence, tapering of this drug, after initiation of risperidone, might still be the prudent course of action.
CHANGE IN CLINICAL STATUS AND SIDE EFFECTS OF PATIENTS TREATED WITH EITHER OLANZAPINE OR RISPERIDONE: SIXMONTH RESULTS FROM THE THREE-YEAR INTERCONTINENTAL SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES (IC-SOHO) OBSERVATIONAL STUDY R R. Gargoloff,* R. A. O'Halloran, J. M. Boland, E. Brunner, M. Dossenbach, L. Levitt, A. Valencia, E. Landa, C. GonzNez Clfnica City Bell, La Plata, Argentina Objective: To compare the 6-month change in clinical status and incidence of side effects in patients who initiated or changed to either olanzapine or risperidone antipsychotic treatment at baseline. Method: This is a 3-year, prospective intercontinental observational study of the health outcomes associated with antipsychotic therapy in outpatients with schizophrenia. Patients were enrolled if, at the discretion of the treating psychiatrist, they initiated or changed antipsychotic medication. There are two principle cohorts: initiated or changed to olanzapine treatment (1), initiated or changed to nonolanzapine treatment (2). Here we report how patients that were prescribed either olanzapine or risperidone at baseline have progressed after 6 months of treatment. Results: A total of 7655 patients across 27 countries in the intercontinental region were included in this study. Overall, 51% of patients were prescribed olanzapine, 20% risperidone. Olanzapine-treated patients improved significantly (p<0.0001) with respect to overall, positive, negative, depressive, and cognitive symptoms (Table 1). Patients prescribed olanzapine had a greater improvement in the severity of tardive dyskinesia (p=0.0445) and a significantly greater improvement in the severity of extrapyramidal symptoms (p<0.000l) compared to risperidonetreated patients. Furthermore, at 6 months risperidone-treated patients were prescribed anticholinergic medications significantly
International Congress on Schizophrenia Research 2003