The SOHO (Schizophrenia Outpatient Health Outcome) Study

Sant Joan de Déu-SSM, Fundació Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain.
CNS Drugs (Impact Factor: 5.11). 02/2006; 20(4):293-301. DOI: 10.2165/00023210-200620040-00003
Source: PubMed


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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    • "EPS/agitation-related side effects were the most strongly associated with nonadherence, and were commonly reported. This is a striking finding because atypical antipsychotics are generally thought to have lower risk for EPS compared to typical antipsychotics [26,27]. Though, it should be noted, not all patients in this study were on an atypical medication the vast majority were. "
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    ABSTRACT: Antipsychotic medications often have a variety of side effects, however, it is not well understood how the presence of specific side effects correlate with adherence in a real-world setting. The aim of the current study was to examine the relationship between these variables among community-dwelling patients with schizophrenia. Data were analyzed from a 2007-2008 nationwide survey of adults who self-reported a diagnosis of schizophrenia and were currently using an antipsychotic medication (N = 876). The presence of side effects was defined as those in which the patient reported they were at least "somewhat bothered". Adherence was defined as a score of zero on the Morisky Medication Adherence Scale. To assess the relationship between side effects and adherence, individual logistic regression models were fitted for each side effect controlling for patient characteristics. A single logistic regression model assessed the relationship between side effect clusters and adherence. The relationships between adherence and health resource use were also examined. A majority of patients reported experiencing at least one side effect due to their medication (86.19%). Only 42.5% reported complete adherence. Most side effects were associated with a significantly reduced likelihood of adherence. When grouped as side effect clusters in a single model, extra pyramidal symptoms (EPS)/agitation (odds ratio (OR) = 0.57, p = 0.0007), sedation/cognition (OR = 0.70, p = 0.033), prolactin/endocrine (OR = 0.69, p = 0.0342), and metabolic side effects (OR = 0.64, p = 0.0079) were all significantly related with lower rates of adherence. Those who reported complete adherence to their medication were significantly less likely to report a hospitalization for a mental health reason (OR = 0.51, p = 0.0006), a hospitalization for a non-mental health reason (OR = 0.43, p = 0.0002), and an emergency room (ER) visit for a mental health reason (OR = 0.60, p = 0.008). Among patients with schizophrenia, medication side effects are highly prevalent and significantly associated with medication nonadherence. Nonadherence is significantly associated with increased healthcare resource use. Prevention, identification, and effective management of medication-induced side effects are important to maximize adherence and reduce health resource use in schizophrenia.
    BMC Psychiatry 03/2012; 12(1):20. DOI:10.1186/1471-244X-12-20 · 2.21 Impact Factor
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    • "Thus, paliperidone would not be expected to be subject to drug-drug interactions mediated through the P-450 system and its dosing would not be expected to differ between slow and rapid metabolizers. The potential for important drug-drug interactions was highlighted in a recently conducted naturalistic analysis across 10 European countries which found that up to 29% of outpatients with schizophrenia were receiving concomitant anticholinergic medications, up to 23% were on antidepressants, up to 37% on anxiolytics, and up to 19% on mood stabilizers (Haro et al 2006). Such high rates of concomitant therapy dramatically increase the likelihood of clinically significant pharmacokinetic drug-drug interactions with unintended consequences for efficacy or tolerability. "
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    ABSTRACT: Antipsychotic medications provide the foundation for treatment of acute exacerbations as well as relapse prevention in patients with schizophrenia as demonstrated by rigorous placebo-controlled trials. However, despite their proven effectiveness, poor adherence to prescribed antipsychotic regimens remains the most important driver of suboptimal clinical outcomes in this population. This paper reviews the magnitude of the problem of medication non-adherence in patients with schizophrenia and the various factors that contribute to non-adherence, with particular emphasis on factors related to antipsychotic medications. The profile of the latest atypical antipsychotic, paliperidone extended-release (ER) tablets, is then reviewed and the implications of its unique pharmacokinetic profile for adherence in this patient population are discussed.
    Patient Preference and Adherence 02/2008; 2:233-40. DOI:10.2147/PPA.S3346 · 1.68 Impact Factor
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    • "In 2002 over one million prescriptions for antipsychotics were written for children and adolescents in ambulatory care (Olfson, Blanco et al 2006). There are significant risks associated with first and second-generation antipsychotics: weight gain, diabetes, hyperlipidemia particularly with the second-generation drugs (Haro et al 2006; Lambert et al 2006; Olfson, Marcus et al 2006), movement disorders (Joy et al 2006; Shirzadi et al 2006), hyperprolactinemia and cardiovascular adverse effects. It is unknown if these risks compound when antipsychotics are prescribed in combinations (Freundreich et al 2002; Stahl et al 2004). "
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    ABSTRACT: There is a growing body of literature supporting the contribution of genetic variability to the mechanisms responsible for the adverse effects of antipsychotic medications particularly movement disorders and weight gain. Despite the current gap between research studies and the practical tools available to the clinician to identify such risks, it is hoped that in the foreseeable future, pharmacogenetics will become a critical aid to guide the development of personalized therapeutic regimes with fewer adverse effects. We provide a summary of two cases that are examples of using cytochrome P450 pharmacogenetics in an attempt to guide treatment in the context of recent literature concerning the role of pharmacogenetics in the manifestation of adverse effects of antipsychotic therapies. These examples and the review of recent literature on pharmacogenetics of antipsychotic adverse effects illustrate the potential for applying the principles of predictive, preventive, and personalized medicine to the therapy of psychotic disorders.
    Neuropsychiatric Disease and Treatment 01/2008; 3(6):965-73. · 1.74 Impact Factor
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