The SOHO (Schizophrenia Outpatient Health Outcome) study: implications for the treatment of schizophrenia.
ABSTRACT The European SOHO (Schizophrenia Outpatient Health Outcome) study is an observational, naturalistic study of the outpatient treatment of schizophrenia. The patient recruitment and assessment began in September 2000 and finished in early 2005. A total of 10 972 adult patients from ten European countries who were initiating or changing antipsychotic medication for the treatment of schizophrenia within the normal course of care have been enrolled. The patients have been followed at regular intervals over the 3-year timeframe of the study. Evaluation includes clinical severity, measured with the Clinical Global Impression (CGI) scale; health-related quality of life; social functioning; and medication tolerability. The 6- and 12-month results have been published so far and have demonstrated that the patients in whom treatment was initiated with olanzapine or clozapine or who were started on more than one antipsychotic of any class at baseline tended to have somewhat greater improvement than patients treated with other atypical or typical antipsychotics, both in terms of symptoms measured with the CGI and quality of life. Numbers of social contacts increased with the treatment, but other aspects of social functioning did not show any significant change. Atypical antipsychotics as a class were associated with a lower frequency of extrapyramidal symptoms (EPS) and anticholinergic use than typical antipsychotics. The frequency of EPS was lowest in the clozapine-, quetiapine- and olanzapine-treated patients, at around 10%. The atypical antipsychotics also conferred a lower risk for tardive dyskinesia than the typical antipsychotics. Weight gain occurred in all treatment cohorts over the first 12 months of treatment and was statistically significantly greater in the patients who started treatment with olanzapine and clozapine. Prolactin- and sexually-related adverse events were frequent at baseline assessment: amenorrhoea was present in around one- third of women, impotence in around 40% of men, and loss of libido in 50% of both male and female patients. Patients treated with olanzapine, clozapine and quetiapine were significantly less likely to have sexual/endocrine-related dysfunctions after 6 months of treatment (the 12-month results of this parameter are yet to be published) than those in the other treatment cohorts (typical antipsychotics, risperidone and amisulpride). Concomitant medication use during the study has been high, ranging from 5% to 29% for anticholinergics, 8% to 23% for antidepressants, 22% to 37% for anxiolytics and 7% to 19% for mood stabilisers, depending on the type of antipsychotic prescribed. Fewer olanzapine-, quetiapine- and clozapine-treated patients used concomitant anticholinergics or anxiolytics/hypnotics. The current results from the SOHO study indicate that differences in effectiveness and tolerability do exist between the antipsychotics. Future results from the study will be published during the coming months and years, and will allow patterns of antipsychotic use in routine clinical practice (including how often and why changes are made) to be determined. This important information is likely to impact on the future use of antipsychotics and will assist clinicians in refining the use of these drugs and improving the outcome of patients to whom they are prescribed.
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ABSTRACT: Background In schizophrenia, medication adherence is critical to achieve better patient outcomes and to avoid relapses, which are responsible for a significant proportion of total healthcare costs for this chronic illness. The aim of this study was to assess the cost-effectiveness of olanzapine long-acting injection (OLAI) compared with risperidone long-acting injection (RLAI) in patients with schizophrenia in Spain.MethodsA discrete event simulation (DES) model was developed from a Spanish healthcare system perspective to estimate clinical and economic outcomes for patients with schizophrenia over a five-year period. Patients who had earlier responded to oral medication and have a history of relapse due to adherence problems were considered. Identical model populations were treated with either OLAI or RLAI. In the absence of a head-to-head clinical trial, discontinuation and relapse rates were obtained from open-label studies. The model accounted for age, gender, risks of relapse and discontinuation, relapse management, hospitalization, treatment switching and adverse events. Direct medical costs for the year 2011 and outcomes including relapse avoided, life years (LYs), and quality-adjusted life years (QALYs) were discounted at a rate of 3%.ResultsWhen comparing RLAI and OLAI, the model predicts that OLAI would decrease 5-year costs by ¿2,940 (Standard Deviation between replications 300.83), and result in a QALY and LY gains of 0.07 (SD 0.019) and 0.04 (SD 0.025), respectively. Patients on OLAI had fewer relapses compared to RLAI (1.392 [SD 0.035] vs. 1.815 [SD 0.035]) and fewer discontinuations (1.222 [SD 0.031] vs. 1.710 [SD 0.039]). Sensitivity analysis indicated that the study was robust and conclusions were largely unaffected by changes in a wide range of parameters.Conclusions The present evaluation results in OLAI being dominant over RLAI, meaning that OLAI represents a more effective and less costly alternative compared to RLAI in the treatment of patients with schizophrenia in the Spanish setting.BMC Psychiatry 12/2014; 14(1):298. DOI:10.1186/s12888-014-0298-4 · 2.24 Impact Factor
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ABSTRACT: The prevalence of diabetes mellitus is twofold to threefold higher in people with severe mental illness (SMI) than in the general population, with diabetes mellitus affecting ∼12% of people receiving antipsychotics. The consequences of diabetes mellitus are more severe and frequent in people with SMI than in those without these conditions, with increased rates of microvascular and macrovascular complications, acute metabolic dysregulation and deaths related to diabetes mellitus. Multiple complex mechanisms underlie the association between diabetes mellitus and SMI; these mechanisms include genetic, environmental and disease-specific factors, and treatment-specific factors. Although antipsychotics are the mainstay of treatment in SMI, a causative link, albeit of uncertain magnitude, seems to exist between antipsychotics and diabetes mellitus. The principles of managing diabetes mellitus in people with SMI are similar to those for the general population and should follow currently established treatment algorithms. Lifestyle interventions are needed to reduce incident diabetes mellitus. In addition, improved uptake of opportunities to screen for this disease will reduce the high prevalence of undiagnosed diabetes mellitus. Currently, people with SMI receive poorer treatment for diabetes mellitus than the general population. Thus, health-care professionals in primary care, diabetes mellitus services and mental health teams have a responsibility to ensure that patients with SMI are not disadvantaged.Nature Reviews Endocrinology 12/2014; 11(2). DOI:10.1038/nrendo.2014.203 · 11.03 Impact Factor
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ABSTRACT: Severe mental illnesses (SMIs), such as schizophrenia and bipolar disorder, persist over time and can cause extensive disability leading to impairments in social and occupational functioning. People with SMI have higher morbidity and mortality due to physical illness than the general population and may be more likely to engage in high-risk sexual behaviour (e.g. unprotected intercourse, having multiple partners, involvement in the sex trade and illicit drug use), putting them at risk of poorer sexual health outcomes including sexually transmitted infections. Sexual health promotion interventions, developed and implemented for people with SMI, may improve participants' knowledge, attitudes, beliefs or behavioural practices and could lead to a reduction in risky sexual behaviour. To evaluate the effectiveness of sexual health interventions for people with SMI compared with usual care and their applicability to the UK NHS setting. Thirteen electronic databases were searched from inception to December 2012. All controlled trials (randomised or non-randomised) that met the following criteria were included: any sexual health promotion intervention or combination of interventions intended to change the knowledge, attitudes, beliefs, behaviours or practices of individuals with SMI (defined as adults aged ≥ 18 years who have received a diagnosis of schizophrenia or bipolar disorder) living in the community. A systematic review of the clinical evidence was undertaken following recommended guidelines. Data were tabulated and discussed in a narrative review. Thirteen randomised controlled studies met the inclusion criteria. The methodological quality of the included studies varied considerably, with only a minority of studies (n = 2) being considered as having very few methodological limitations. Despite wide variations in the study populations, interventions, comparators and outcomes, four studies showed significant improvements in all measured sexual risk behaviour outcomes (e.g. human immunodeficiency virus knowledge and behaviour change) in the intervention groups compared with the control groups. In contrast, four studies found significant improvements in the intervention groups for some outcomes only and three studies found significant improvements in certain subgroups only, based on either gender or ethnicity. Finally, two studies reported no significant differences in any sexual risk behaviour outcomes between the intervention and control groups. Moreover, positive findings were not consistently sustained at follow-up in many studies. Little detail was provided in the studies regarding the content of interventions, how they were delivered and by whom, making replication or generalisability difficult. Owing to the large between-study variability (especially in the populations, interventions, comparators and reported outcomes) and mixed results, there is insufficient evidence to fully support or reject the identified sexual health interventions for people with SMI. In addition, there are considerable uncertainties around the generalisability of these findings to the UK setting. Further research recommendations include well-designed, UK-based trials of sexual health interventions for people with SMI as well as training and support for staff implementing sexual health interventions. PROSPERO number CRD42013003674. The National Institute for Health Research Health Technology Assessment Programme.01/2014; 18(1):1-74. DOI:10.3310/hta18010