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Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study.

ABSTRACT: BACKGROUND:Patients under antipsychotic treatment for schizophrenia commonly exhibit poor adherence to treatment, high rates of treatment discontinuation, and frequent treatment changes. The ETOS study aimed to identify the reasons leading physicians to decide to switch antipsychotic treatment in outpatients with schizophrenia and to evaluate the outcome of this switch. METHODS:ETOS was an observational 18-week (four visits) study in outpatients 18 to 65 years old, diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders - 4th edition criteria at least 6 months prior to enrolment, who were initiated on a new antipsychotic monotherapy treatment within the 2 weeks prior to enrollment. A total of 574 patients were recruited by 87 hospital- and office-based physicians. Ethical approval was obtained prior to study initiation (NCT00999895). RESULTS:The final analysis included 568 patients, 39.0?±?11.2 years old with mean disease duration of 11.7 years. The male-to-female ratio was 53:47. The main reason for switching antipsychotic treatment was lack of tolerability (n?=?369, 65.0%), followed by lack of efficacy (n?=?249, 43.8%). Following treatment switch, 87.9% of patients (n?=?499) showed meaningful clinical benefit by achieving a Clinical Global Impression-Clinical Benefit score of ?4 at the final visit. By the end of the study, total Positive and Negative Syndrome Scale, Clinical Global Impression-Improvement, Clinical Global Impression-Severity, and Simpson-Angus Scale scores demonstrated significant mean decreases of 31.69, 0.70, 1.14, and 11.30, respectively (all p?

SUBMITTER: Roussidis A

PROVIDER: S-EPMC3878189 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study.

Roussidis Andreas A Kalkavoura Christina C Dimelis Dimos D Theodorou Afroditi A Ioannidou Ina I Mellos Eleytherios E Mylonaki Triantafyllia T Spyropoulou Areti A Yfantis Andreas A

Annals of general psychiatry 20131220 1

<h4>Background</h4>Patients under antipsychotic treatment for schizophrenia commonly exhibit poor adherence to treatment, high rates of treatment discontinuation, and frequent treatment changes. The ETOS study aimed to identify the reasons leading physicians to decide to switch antipsychotic treatment in outpatients with schizophrenia and to evaluate the outcome of this switch.<h4>Methods</h4>ETOS was an observational 18-week (four visits) study in outpatients 18 to 65 years old, diagnosed with ...[more]

PMID: 24359635

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Project description:BackgroundsTo explain the excess cardiovascular mortality observed in the SERVE-HF study, it was hypothesized that the high-pressure ASV default settings used lead to inappropriate ventilation, cascading negative consequences (i.e. not only pro-arrythmogenic effects through metabolic/electrolyte abnormalities, but also lower cardiac output). The aims of this study are: i) to describe ASV-settings for long-term ASV-populations in real-life conditions; ii) to describe the associated minute-ventilations (MV) and therapeutic pressures for servo-controlled-flow versus servo-controlled-volume devices (ASV-F Philips®-devices versus ASV-V ResMed®-devices).MethodsThe OTRLASV-study is a cross-sectional, 5-centre study including patients who underwent ASV-treatment for at least 1 year. The eight participating clinicians were free to adjust ASV settings, which were compared among i) initial diagnosed sleep-disordered-breathing (SBD) groups (Obstructive-Sleep-Apnea (OSA), Central-Sleep-Apnea (CSA), Treatment-Emergent-Central-Sleep-Apnea (TECSA)), and ii) unsupervised groups (k-means clusters). To generate these clusters, baseline and follow-up variables were used (age, sex, body mass index (BMI), initial diagnosed Obstructive-Apnea-Index, initial diagnosed Central-Apnea-Index, Continuous-Positive-Airway-Pressure used before ASV treatment, presence of cardiopathy, and presence of a reduced left-ventricular-ejection-fraction (LVEF)). ASV-data were collected using the manufacturer's software for 6 months.ResultsOne hundred seventy-seven patients (87.57% male) were analysed with a median (IQ25-75) initial Apnea-Hypopnea-Index of 50 (38-62)/h, an ASV-treatment duration of 2.88 (1.76-4.96) years, 61.58% treated with an ASV-V. SDB groups did not differ in ASV settings, MV or therapeutic pressures. In contrast, the five generated k-means clusters did (generally described as follows: (C1) male-TECSA-cardiopathy, (C2) male-mostly-CSA-cardiopathy, (C3) male-mostly-TECSA-no cardiopathy, (C4) female-mostly-elevated BMI-TECSA-cardiopathy, (C5) male-mostly-OSA-low-LVEF). Of note, the male-mostly-OSA-low-LVEF-cluster-5 had significantly lower fixed end-expiratory-airway-pressure (EPAP) settings versus C1 (p = 0.029) and C4 (p = 0.007). Auto-EPAP usage was higher in the male-mostly-TECSA-no cardiopathy-cluster-3 versus C1 (p = 0.006) and C2 (p < 0.001). MV differences between ASV-F (p = 0.002) and ASV-V (p < 0.001) were not homogenously distributed across clusters, suggesting specific cluster and ASV-algorithm interactions. Individual ASV-data suggest that the hyperventilation risk is not related to the cluster nor the ASV-monitoring type.ConclusionsReal-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful. At the patient level, a hyperventilation risk exists regardless of cluster or ASV-monitoring type, spotlighting a future role of MV-telemonitoring in the interest of patient-safety.Trial registrationThe OTRLASV study was registered on ClinicalTrials.gov (Identifier: NCT02429986 ). 1 April 2015.

Project description:It has remained unclear whether there are clinically meaningful differences between antipsychotic treatments with regard to preventing relapse of schizophrenia, owing to the impossibility of including large unselected patient populations in randomized clinical trials, as well as residual confounding from selection biases in observational studies.To study the comparative real-world effectiveness of antipsychotic treatments for patients with schizophrenia.Prospectively gathered nationwide databases were linked to study the risk of rehospitalization and treatment failure from July 1, 2006, to December 31, 2013, among all patients in Sweden with a schizophrenia diagnosis who were 16 to 64 years of age in 2006 (29?823 patients in the total prevalent cohort; 4603 in the incident cohort of newly diagnosed patients). Within-individual analyses were used for primary analyses, in which each individual was used as his or her own control to eliminate selection bias. Traditional Cox proportional hazards multivariate regression was used for secondary analyses.Risk of rehospitalization and treatment failure (defined as psychiatric rehospitalization, suicide attempt, discontinuation or switch to other medication, or death).There were 29?823 patients (12?822 women and 17?001 men; mean [SD] age, 44.9 [12.0] years). During follow-up, 13?042 of 29?823 patients (43.7%) were rehospitalized, and 20?225 of 28?189 patients (71.7%) experienced treatment failure. The risk of psychiatric rehospitalization was the lowest during monotherapy with once-monthly long-acting injectable paliperidone (hazard ratio [HR], 0.51; 95% CI, 0.41-0.64), long-acting injectable zuclopenthixol (HR, 0.53; 95% CI, 0.48-0.57), clozapine (HR, 0.53; 95% CI, 0.48-0.58), long-acting injectable perphenazine (HR, 0.58; 95% CI, 0.52-0.65), and long-acting injectable olanzapine (HR, 0.58; 95% CI, 0.44-0.77) compared with no use of antipsychotic medication. Oral flupentixol (HR, 0.92; 95% CI, 0.74-1.14), quetiapine (HR, 0.91; 95% CI, 0.83-1.00), and oral perphenazine (HR, 0.86; 95% CI, 0.77-0.97) were associated with the highest risk of rehospitalization. Long-acting injectable antipsychotic medications were associated with substantially lower risk of rehospitalization compared with equivalent oral formulations (HR, 0.78; 95% CI, 0.72-0.84 in the total cohort; HR, 0.68; 95% CI, 0.53-0.86 in the incident cohort). Clozapine (HR, 0.58; 95% CI, 0.53-0.63) and all long-acting injectable antipsychotic medications (HRs 0.65-0.80) were associated with the lowest rates of treatment failure compared with the most widely used medication, oral olanzapine. The results of several sensitivity analyses were consistent with those of the primary analyses.Clozapine and long-acting injectable antipsychotic medications were the pharmacologic treatments with the highest rates of prevention of relapse in schizophrenia. The risk of rehospitalization is about 20% to 30% lower during long-acting injectable treatments compared with equivalent oral formulations.

Project description:Outpatient facilities, such as community behavioral health organizations (CBHOs), play a critical role in the care of patients with serious mental illness, but there is a paucity of "real-world" patient outcomes data from this health care setting. Therefore, we conducted The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) trial, a real-world, prospective, noninterventional observational study of patients with mental illness treated at CBHOs across the United States. We describe demographic and clinical characteristics, antipsychotic therapy (APT) treatment patterns, and health care resource utilization in patients with schizophrenia undergoing medical care as usual.This study enrolled adults with schizophrenia or bipolar I disorder who initiated APT treatment at various time points: 1) within 8 weeks of initiating risperidone long-acting injectables (RLAIs) or other APTs except paliperidone palmitate (PP), 2) after more than 24 weeks of continuous RLAI treatment, or 3) at any time after initiating PP LAI treatment (schizophrenia only). Study assessments were performed via participant interview, medical chart abstraction, and clinical survey at enrollment and at month 12.A total of 1065 patients from 46 CBHOs were enrolled. Of these, 944 (88.6%) had a diagnosis of schizophrenia and 121 (11.4%) had bipolar I disorder. At enrollment, 599 (63.5%) of patients with schizophrenia were receiving RLAIs or PP LAI, 281 (29.8%) were receiving oral APTs, and 64 (6.8%) were receiving other injectable APTs. A number of differences in patient characteristics and outcomes were observed between patients in the LAI APT cohort and the oral APT cohort.Descriptive analyses from this observational study suggest differences in the patient characteristics, treatment patterns, and clinical and economic outcomes among those with schizophrenia treated at CBHOs with LAI APT or oral APTs. Additional analyses will be conducted to delineate the impact of LAI APT versus oral APTs on patient outcomes.Clinical Trial Registry: NCT01181960 . Registered 12 August 2010.

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Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study.

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Reasons and clinical outcomes of antipsychotic treatment switch in outpatients with schizophrenia in real-life clinical settings: the ETOS observational study.

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