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Background: This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia., Method: This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy., Results: 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS., Conclusion: In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

Background and Objective: This study assessed the safety and effectiveness of the atypical antipsychotic olanzapine for the treatment of inpatients with acute schizophrenia. Furthermore, we evaluated patterns of use of olanzapine and their relationship to safety and effectiveness., Patients and Method: This was a prospective, comparative, nonrandomized, open-label, observational study of 848 patients with schizophrenia (International Classification of Diseases, 10th edition) hospitalized due to an acute psychotic episode. Data were collected during patients' entire hospital stay. Safety of antipsychotic therapy was assessed with an extrapyramidal symptoms questionnaire (based on the Udvalg for Kliniske Undersøgelser scale) and the report of spontaneous adverse events. Clinical status was assessed with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate statistical approach was employed., Results: Patients treated with olanzapine in monotherapy had the lowest risk of developing extrapyramidal symptoms (11.2%), whereas patients treated with conventional antipsychotics had a higher risk (39.0%; p < 0.001). Patients treated with olanzapine in monotherapy (even patients with prominent positive symptoms) displayed a higher rate of response compared with conventional antipsychotics-treated patients (p = .007)., Conclusions: Olanzapine is a safe and effective treatment for patients with acute schizophrenia in the hospital setting, even for patients with prominent positive or agitation symptoms.

Objective: To assess the safety and effectiveness of olanzapine compared to typical antipsychotics in the treatment of first-episode schizophrenics in acute psychiatric inpatient wards., Methods: Data were collected from a prospective, comparative, nonrandomized, open, observational study of 904 inpatients with schizophrenia. One hundred and fifty-eight patients fulfilled the criteria for first-episode schizophrenia, defined as (1) the International Classification of Diseases: Mental and Behavioral Disorders, 10th ed. (ICD-10) diagnosis of schizophrenia, (2) antipsychotic nai;ve, and (3) a course of illness of less than 5 years. Eighty-nine (56.3%) of these patients were assigned to the olanzapine treatment group (OLZ) and 69 (43.7%) to the control group that received treatment with conventional antipsychotics (CON). Safety was evaluated in terms of the spontaneous adverse events reported and a specific questionnaire for extrapyramidal symptoms (EPS). Clinical status was measured by means of the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression of Severity (CGI-S). Clinical response was defined as the baseline-endpoint decrease in BPRS>40% plus an endpoint BPRS<18 or an endpoint CGI

Background: Conventional antipsychotics although effective in treating acute psychotic and behavioural symptoms are subject to certain limitations due to the high incidence of side effects associated, mainly extrapyramidal symptoms (EPS), and insufficient response shown in some cases. EPS are a major factor in neuroleptic non compliance and high relapse rates among patients. This study was designed to assess the safety and effectiveness of olanzapine compared to typical antipsychotics drugs in the treatment of schizophrenic inpatients at acute psychiatric in-patient units., Method: Data from 904 patients schizophrenic patients (F20 of ICD10, WHO) were collected in this prospective, comparative, non-randomized, open and observational study. Patients were followed during their entire hospital stay. Safety was assessed through the collection of spontaneous adverse events and a specific extrapyramidal symptoms questionnaire (EPS). Clinical status was measured through the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression of Severity (CGI-S), Patient Global Impression of Improvement (PGI) and the Nursing Observational Scale for In-patient Evaluation (NOSIE)., Results: A total of 483 patients received olanzapine (olanzapine group, OG), and 421 received typical antipsychotics (control group, CG). Treatment emergent EPS, or worsening of previous EPS were statistically significantly higher in the CG (P=0.001). Responder rate was statistically greater in the OG (P<0.001). Mean change in BPRS-total, BPRS-negative, BPRS-agitation subscales and PGI was significantly higher in the OG (P<0.001). Mean decrease in CGI, BPRS positive and BPRS depression sub-scales was also significantly lower (P< or =0.05). Mean change in the NOSIE scale was similar between both groups., Conclusion: Olanzapine has been shown to be better tolerated in comparison with conventional antipsychotics in a large unselected sample of acutely psychotic schizophrenic in-patients. Its effectiveness may be greater than that of conventional antipsychotics.

Nine hundred and ten schizophrenic inpatients suffering from acute psychotic episodes were included in a naturalistic study. Patients were prescribed treatment with olanzapine (OLZ) or with typical antipsychotic (TYP) drugs. Patients receiving another atypical antipsychotic were excluded. Of the whole sample, 483 (53.4%) were treated with olanzapine and 421 (46.6%) with typical antipsychotics. Three specific subpopulations of greater severity were defined: patients with prominent psychotic symptoms, agitated patients, and patients initially treated with intramuscular (i.m.) medication because of their acute clinical condition. Severity of illness was assessed using the Clinical Global Impression (CGI) scale for severity, the Brief Psychiatric Rating Scale (BPRS) and the Nursing Observational Scale for Inpatient Evaluation. Baseline differences were adjusted per data analysis. The mean change from baseline to endpoint of overall symptomatology (total BPRS score) was significantly greater in the olanzapine group compared to the typical antipsychotic-treated group, both in the sample of patients with prominent positive symptoms (P < 0.001) and in the sample of agitated patients (P =0.015). Significant differences were also found in BPRS positive scores, BPRS negative scores and CGI scores in these two populations. Patients who had received previous i.m. drugs showed no statistically significant differences in symptomatic improvement between both treatments groups, except for a more favourable response of BPRS negative subscores in the olanzapine group (P =0.015). The results suggest that olanzapine may be considered as a first line treatment for severely psychotic inpatients with schizophrenia.

Objectives: 1. Assess the evolution of disability and quality of life in schizophrenic patients treated with risperidone and who had received depot neuroleptics; 2. Evaluate risperidone efficiency; 3. Evaluate safety of this drug., Method: Post-marketing multicentric observational (8 months) surveillance study was carried out., Patients: 109 schizophrenic patients (ICD-10 criteria)., Assessments: baseline and months 2, 4 and 8., Instruments: SF-36, WHO/DDS-S, BPRS and CGI. Safety was evaluated by the UKU subscale for neurological side effects and spontaneous reports., Results: statistically significant improvement of the mean scores of BPRS, CGI, WHO/DDS-S and SF-36 at 2, 4 and 8 months. There was a significant reduction in the total UKU subscale for neurological side effects scores from visit 1 (month 2) onwards. Risperidone was generally well tolerated by the study patients. From a total of 104 patients included, only 4 (3.8%) discontinued treatment due to adverse reactions. During the 8 months of study period, 87.6% of the patients did not suffer any adverse event; the resting 12.4 suffered one or more side effects. The most frequently reported adverse events according spontaneous reports were: anxiety and restlessness (n= 4; 3.8%), weight increase (n= 4; 3.8%), sexual disturbances (n= 4; 3.8%) and amenorrhea (n= 2; 1.9%) among others., Conclusion: the long-term treatment with risperidone has improved the disability and quality of life levels of a large group of schizophrenic patients previously treated with depot neuroleptics.

Objective: To determine the evolution of the degree of long term disability (8 months) in a group of schizophrenic outpatients undergoing monotherapy with risperidone. DESIGN, An observational multicentre study of 8 months follow up., Patients: 354 patients with schizophrenic disorder (ICD-10)., Evaluation: Baseline, 2, 4 and 8 months., Instruments: BPRS, CGI, UKU, WHO/DAS-S., Results: a significant decrease in both the global scores and in each of the 4 areas of disability. Improvement in disability depends to a large degree on the improvement of the disorder as shown on the BPRS and CGI. After 8 months, those patients with paranoid subtype and the less severe ones (BPRS and CGI) showed a considerably lesser degree of disability. The final level of disability (square root = 0,61) is narrowly related to the baseline level of disability, the 3 clusters of the final BPRS, the final CGI, gender and the subtype of schizophrenia.

A total of 439 schizophrenic patients according to ICD-10 criteria was included in an open label postmarketing surveillance study to evaluate the efficiency of resperidone as maintenance treatment of the schizophrenic acute exacerbation. The efficiency of risperidone was assessed according the number of patients who responded to treatment, the duration of the hospitalization period an the decrease in the total score as well as in the different clusters of the Brief Psychiatric Rating Scale (BPRS) during the study period. A patient was considered as responder to treatment when a decrease of, at least, a 20% was achieved in the total BPRS score while being treated in monotherapy with risperidone. Safety was evaluated by the UKU subscale for neurological side effects and spontaneous reports. Patients were evaluated at baseline and weeks 1, 2, 6 and 12. Forty patients (9.1%) were excluded from the statistical analysis due to protocol violation. Eighty one patients (20.3%) dropped out due to lost for follow-up (n = 25; 6.3%), new hospitalization (n = 23; 5.8%), inefficacy (n = 12; 3%), side effects (n = 7; 1.8%) and others (n = 14; 3.5%). Risperidone was used at doses between 1.5 and 19 mg daily (mean dosage: 7.66 +/- 3.07 mg daily). The duration of the hospitalization when dosages of risperidone of less than 6 mg daily were used was 32.1 days. However, when higher dosages were used, the number of days in-hospital decreased (26.6 days at dosages between 6 and 9 mg daily and 25.3 days when dosages higher than 9 mg daily were used). There was a significant reduction, versus baseline, in the BPRS mean total scores as well as in it's different clusters. (positive symptoms, negative symptoms, anxiety/depression) from week one onwards. At week 1, 66.9% of the patients had an improvement (20% versus baseline in their BPRS total score. At the end of the study period, 93.2% of the patients had an improvement (20% in their BPRS total score. There was a significant reduction in the total UKU subscale for neurological side effects scores (p < 0.005) from week 1 onwards, as well as for the total score of the following symptoms: rigidity, hypokinesia, hyperkinesia tremor and akatysia.