Long-term antipsychotic monotherapy for schizophrenia: disease burden and comparative outcomes for patients treated with olanzapine, quetiapine, risperidone, or haloperidol monotherapy in a pan-continental observational study.

OBJECTIVE: Noninterventional, naturalistic studies facilitate examination of current clinical practices and provide an understanding of the impact of the biopsychosocial aspects of schizophrenia. This article describes disease burden and patient outcomes, with an emphasis on the comparative effectiveness and tolerability of antipsychotic monotherapy. METHOD: Outpatients initiating or changing antipsychotic therapy for DSM-IV- or ICD-10-defined schizophrenia (N = 7658) were allocated to olanzapine or nonolanzapine cohorts (November 2000 to December 2001). Treatment was at the psychiatrist's discretion, including flexible dosing and use of concomitant therapies and medications, with assessments at 0, 3, 6, 12, 18, 24, 30, and 36 months. Longitudinal clinical, pharmacologic, functional, and social data were collected over 36 months across 27 countries. RESULTS: At entry, 76% of patients were initiated/switched to antipsychotic monotherapy, most commonly with olanzapine (N = 3222), risperidone (N = 1117), quetiapine (N = 189), or haloperidol (N = 257). Patients prescribed olanzapine were more likely to maintain their baseline monotherapy (p < .001) and did so for a longer period (p < .001) compared with other antipsychotics. Median time to discontinuation (in months) was as follows: olanzapine 30.0, risperidone 23.1, quetiapine 13.9, haloperidol 12.5. Olanzapine-treated patients were also more likely to respond, and did so more rapidly than patients on other monotherapies (p < .001). Response data were also favorable for risperidone; median time to response (in months) was as follows: olanzapine 5.2, risperidone 6.3, quetiapine 11.3, haloperidol 11.7. Treatment-emergent adverse events varied: olanzapine patients had less favorable odds for significant weight gain (p < .001); haloperidol patients, for motor dysfunction (p < or = .002). CONCLUSION: These naturalistic data from less-studied outpatient communities highlight the variability in clinical and functional outcomes associated with long-term antipsychotic treatment.

Prevalence of sexual dysfunction in patients with schizophrenia: international variation and underestimation.

The prevalence of sexual dysfunction in schizophrenia patients was investigated as part of this large (n = 7655), prospective, international (27 countries) study. Based on patient reports, sexual dysfunction affected approx. 50% of patients and the prevalence of complaints varied significantly between regions (p < 0.0001). The prevalence of sexual dysfunction, as perceived by psychiatrists, also varied significantly across regions (p < 0.0001). Psychiatrists significantly underestimated the presence of impotence/sexual dysfunction (p < 0.0001) and loss of libido (p < 0.0001), compared to reports from patients. The frequency of sexual dysfunction was significantly higher in patients who had been using prolactin-elevating antipsychotics prior to study entry, compared to those who had been treated with prolactin-sparing antipsychotics (patient reports, p = 0.002; psychiatrist perception, p = 0.0004). This study has shown that the prevalence of sexual dysfunction is high in both male and female patients with schizophrenia and frequently underestimated by psychiatrists. Regional variation is evident in both psychiatrist perceptions and patient reports of sexual dysfunction. Given the importance of sexual function to quality of life and treatment compliance, proactive assessment of sexual function is required to optimize schizophrenia management.

The intercontinental schizophrenia outpatient health outcomes (ic-soho) study: baseline clinical and functional characteristics and antipsychotic use patterns in the central and eastern europe (cee) region.

OBJECTIVE: To describe the baseline findings of the Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO) study in the Central and Eastern European sub-region (CEE-SOHO). METHOD: The IC-SOHO study is an ongoing prospective, three-year, non-interventional observational study of schizophrenia treatment, clinical characteristics and mental health services utilization in eight Central and Eastern European countries. The study population consists of non-hospitalized patients who had initiated treatment with or changed to a new antipsychotic. RESULTS: The baseline findings of the IC-SOHO study (CEE-SOHO Subset) appear to reflect clinical practice in Russia, Poland, Czech Republic, Slovakia, Slovenia, Hungary, Romania and Lithuania (N=2,247). Overall, the patients were moderately to markedly ill and either overweight or obese (61.1%) when they entered the study. Functionally, the majority of patients was not involved in a relationship, could not care for themselves and was unemployed. Substance and alcohol dependency/abuse was not a problem in this study population. At baseline, half of the patients were treated with the newer atypical antipsychotics; and anxiolytics/hypnotics were the most commonly prescribed concomitant medication. Sexual side effects were most frequently reported among the surveyed adverse events. Overall patient compliance/ adherence to medication was good. CONCLUSION: The baseline IC-SOHO data highlighted various clinical and functional characteristics and antipsychotic use patterns in a group of outpatients with schizophrenia in a naturalistic setting. Once completed, the IC-SOHO study will add further to this knowledge base.