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P.3.133 Risperidone long acting injectable in elderly psychotic patients: assessment of tolerability and efficacy
P3 Psychotic disorders and antipsychotics mental (smoking, sedentary lifestyle, poor diet), and iatrogenic (antipsychotic drug treatment) aspects have been recognised to explain the association between schizophrenia and cardiovascular disease. The purpose of the present study was to provide prevalence estimates of metabolic risk factors associated with cardiovascular disease in patients with schizophrenia, the use of which might assist health care providers in planning programs for somatic care of these patients. M e t h o d s a n d m a t e r i a l : This cross-sectional study involved 30 centres in Denmark and 14 centres in Sweden, including both in- and outpatient facilities. Consecutive screening procedures were applied. The inclusion criteria were a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, and continuous treatment with any atypical antipsychotic drug for at least three months prior to inclusion. The study procedures included obtaining a thorough medical history, a clinical examination, and fasting blood samples drawn for determination of relevant metabolic parameters, including plasma glucose, lipid profile, and insulin. A total of 687 subjects (401 male, 286 female) were recruited. Their mean age was 39.8 years (SD 10.2 years), and their mean duration of psychosis was 8.9 years (SD 8.1 years). Olanzapine was the most commonly prescribed drug in the sample (37%), followed by risperidone (27%) and clozapine (19%). Sixty-one percent of the subjects were current smokers. Results: Obesity, defined as a body mass index (BMI) greater than 30kg/m2, was present in 39% (95%CI: 35 43%) of the subjects. Insulin resistance, evaluated by the homeostatic model assessment (HOMA), was detected in 68% (95%CI: 64 72%). Glucose intolerance, i.e. fasting plasma glucose in the range 6.1 7 mmol/1 and/or previously diagnosed, was identified in 20% (95%CI: 16 23%). Dyslipidaemia, defined as any abnormality in cholesterol fractions or triglycerides, was a very common finding, occurring in 79% (95%CI: 76 82%) of subjects. Ten percent of the subjects (95%CI: 8 12%) had a medical history of hypertension. Various definitions (WHO, EGIR, and NCEP) of the metabolic syndrome were applied, and prevalence estimates in the range 43 51% were found. Thirty percent of the subjects fulfilled the criteria for all three definitions of the metabolic syndrome. C o n c l u s i o n : The most important finding of this cross-sectional study in schizophrenic patients on atypical antipsychotic drug treatment was the high prevalence of cardiovascular risk factors like insulin resistance and the metabolic syndrome. Prevalence rates for the metabolic syndrome were at least twice the rates observed in a normal, non-diabetic population. The results emphasises the need for systematic screening and follow-up on cardiovascular risk factors in patients with schizophrenia, and calls for a multidisciplinary approach in order to limit their total burden of illness.
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Risperidone long acting injectable in elderly psychotic patients: assessment of tolerability and efficacy
S. Simpson 1 *, M. Heise 2, K. Konstantinos 3 , P. Glue 4 , R. Medori 5 , W. Kissling 6. ]The Forston Clinic, Clinical Trials Unit,
Dorset, United Kingdom; 2private Practice, Berlin, Germany; 3Psychiatric Hospital of Attica, Psychiatric Departement, Greece; 4 Vestfyn, Psychiatric Team, Denmark; Sjanssen Cilag, Medical Affairs EMEA, Belgium," 6Klinikum Rechts der Ism; Klinik fuer Psychiatty und Psychotherapie, Germany Objective: The treatment of elderly schizophrenic patients is a challenge for physicians as tolerability and co-medication might
$513
change over years. The efficacy and safety of risperidone longacting injectable was investigated in patients with schizophrenia or other psychotic disorders, transitioned directly from their existing medication. This paper presents results on a subgroup aged over 65 years. M e t h o d s : Patients requiring a change in antipsychotic medication received risperidone long-acting injectable 25 mg (increased to 37.5mg or 50mg, if necessary) every 14 days without an oral risperidone run-in. Results: Of the 52 patients (64% male, mean age 71 years) 71% had a DSM-IV diagnosis of schizophrenia, and 14% schizoaffective disorders. Eighty-one percent completed the 6-month treatment. Most patients started on 2 5 m g (88%), at endpoint 60% were still receiving this dosage. Reasons for premature withdrawal were: Adverse events (ALE) (12%), withdrawal of consent (6%); 1 patient died (2%) due to concomitant illnesses unrelated to trial medication. Mean total PANSS score at baseline was significantly reduced at treatment endpoint (Table 1). So were the positive, negative and general psychopathology subscales as well as the symptom factors (according to Marder et al. [1]). At endpoint, 47% of patients showed an improvement more than or equal to 20% in PANSS total score. Table 1: PANSS total score (shiRs versus baseline p < 0.001) Timepoint
Baseline Month 1 Month 3 Month 6 Endpoint
Mean 80.9 Standard Deviation ±25.1
72.1 ±23.0
64.3 ±22.6
62.7 ±21.6
65.1 ±23.5
CGI-Disease severity improved significantly (p < 0.001). Overall 66% of the patients experienced improvements in GAF score and mean GAF score improved significantly from 56.6 (moderate symptoms, moderate difficulty in social functioning) to 63.8 (some mild symptoms or difficulty in social functioning, but generally well functioning) (p < 0.001). At endpoint, 50% of patients rated their satisfaction as 'very good' compared with 2% at baseline. The most common AEs were parkinsonism and extrapyramidal disorders (8 patients each). The most frequent AE leading to discontinuation were psychiatric disorders (2 patients). Severity of movement disorder (measured with standard neurology rating scales) decreased during the study (p <0.001). EPS-related AEs were reported in 10 patients. Only one glucose-related-treatmentemergent-AE was reported and serious AEs in 12 patients. The most frequent SAEs were psychiatric disorders and general medical conditions (3 events each) leading to trial discontinuation in 3 cases. C o n c l u s i o n : There was a marked holistic improvement in symptoms of schizophrenia, neurological signs, patient satisfaction and functioning in the studied patient population. Changing the antipsychotic treatment of elderly patients with schizophrenia to risperidone long-acting injectable may be beneficial and is well tolerated
References [1] Marder S.R., Davis LM., Chouinard G., 1997. The effects offispefidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin PsychiatLy 58, 538 546.
•
Risperidone long acting injectable in elderly psychotic patients: assessment of tolerability and efficacy
S. Simpson 1 *, M. Heise 2, K. Konstantinos 3 , P. Glue 4 , R. Medori 5 , W. Kissling 6. ]The Forston Clinic, Clinical Trials Unit,
Dorset, United Kingdom; 2private Practice, Berlin, Germany; 3Psychiatric Hospital of Attica, Psychiatric Departement, Greece; 4 Vestfyn, Psychiatric Team, Denmark; Sjanssen Cilag, Medical Affairs EMEA, Belgium," 6Klinikum Rechts der Ism; Klinik fuer Psychiatty und Psychotherapie, Germany Objective: The treatment of elderly schizophrenic patients is a challenge for physicians as tolerability and co-medication might
$513
change over years. The efficacy and safety of risperidone longacting injectable was investigated in patients with schizophrenia or other psychotic disorders, transitioned directly from their existing medication. This paper presents results on a subgroup aged over 65 years. M e t h o d s : Patients requiring a change in antipsychotic medication received risperidone long-acting injectable 25 mg (increased to 37.5mg or 50mg, if necessary) every 14 days without an oral risperidone run-in. Results: Of the 52 patients (64% male, mean age 71 years) 71% had a DSM-IV diagnosis of schizophrenia, and 14% schizoaffective disorders. Eighty-one percent completed the 6-month treatment. Most patients started on 2 5 m g (88%), at endpoint 60% were still receiving this dosage. Reasons for premature withdrawal were: Adverse events (ALE) (12%), withdrawal of consent (6%); 1 patient died (2%) due to concomitant illnesses unrelated to trial medication. Mean total PANSS score at baseline was significantly reduced at treatment endpoint (Table 1). So were the positive, negative and general psychopathology subscales as well as the symptom factors (according to Marder et al. [1]). At endpoint, 47% of patients showed an improvement more than or equal to 20% in PANSS total score. Table 1: PANSS total score (shiRs versus baseline p < 0.001) Timepoint
Baseline Month 1 Month 3 Month 6 Endpoint
Mean 80.9 Standard Deviation ±25.1
72.1 ±23.0
64.3 ±22.6
62.7 ±21.6
65.1 ±23.5
CGI-Disease severity improved significantly (p < 0.001). Overall 66% of the patients experienced improvements in GAF score and mean GAF score improved significantly from 56.6 (moderate symptoms, moderate difficulty in social functioning) to 63.8 (some mild symptoms or difficulty in social functioning, but generally well functioning) (p < 0.001). At endpoint, 50% of patients rated their satisfaction as 'very good' compared with 2% at baseline. The most common AEs were parkinsonism and extrapyramidal disorders (8 patients each). The most frequent AE leading to discontinuation were psychiatric disorders (2 patients). Severity of movement disorder (measured with standard neurology rating scales) decreased during the study (p <0.001). EPS-related AEs were reported in 10 patients. Only one glucose-related-treatmentemergent-AE was reported and serious AEs in 12 patients. The most frequent SAEs were psychiatric disorders and general medical conditions (3 events each) leading to trial discontinuation in 3 cases. C o n c l u s i o n : There was a marked holistic improvement in symptoms of schizophrenia, neurological signs, patient satisfaction and functioning in the studied patient population. Changing the antipsychotic treatment of elderly patients with schizophrenia to risperidone long-acting injectable may be beneficial and is well tolerated
References [1] Marder S.R., Davis LM., Chouinard G., 1997. The effects offispefidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin PsychiatLy 58, 538 546.