The effect of paliperidone extended release on subjective well-being and responses in patients with schizophrenia
ABSTRACT This study aimed to evaluate the subjective well-being and attitudes toward antipsychotic medication of patients with schizophrenia who had switched to paliperidone extended release (ER).
A total of 291 patients with schizophrenia treated with antipsychotics participated in this open-label, 24-week switching study. The primary outcome measures were the Subjective Well-Being under Neuroleptic Treatment Scale-short version (SWN-K) and the Drug Attitude Inventory (DAI). The Krawiecka scale, Clinical Global Impression-Schizophrenia (CGI-SCH), Personal and Social Performance scale (PSP) were used to evaluate psychopathology and psychosocial functioning, respectively.
Data from a total of 243 subjects who received the study medication and had at least one follow-up assessment without a major protocol violation were analyzed. Scores on the DAI and SWN-K showed significant improvement between baseline and end-point measurements beginning during the second week. Scores on the Krawiecka scale, all five subscales of the CGI-SCH scale, and the PSP scale were also significantly improved at the end point compared with the baseline. Significant predictors of improvements in the SWN-K and DAI after a switch to paliperidone ER were baseline scores, reductions in scores on the Krawiecka scale, and previous risperidone use. A clinically relevant increase in body weight (≥7% weight gain) occurred in one-fourth of the participants who completed the 24-week study.
Switching to paliperidone ER improved the subjective well-being and attitudes towards antipsychotic medication in patients with schizophrenia. Exploratory analyses revealed that these improvements were particularly pronounced in patients who had been treated with risperidone before treatment with paliperidone ER.
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ABSTRACT: Paliperidone extended-release tablet (paliperidone ER) is a new oral psychotropic agent developed for schizophrenia treatment. There have been some studies about paliperidone's good efficacy and tolerability. Clinicians appear to change the antipsychotic medication to paliperidone ER. However, it is not known what patients are favorable responsive to paliperidone ER. The aim of this study was to evaluate the characteristics of early responders and investigate predictors of acute response when the medications changed to paliperidone ER. Data were analyzed from schizophrenic patients who participated in a multi-center, open-label, non-comparative clinical trial. Total 320 patients were examined in this study. Sociodemographic, psychopathology, social function and metabolic data were evaluated. Unpaired t-test for continuous and χ(2) for categorical data, respectively, were used to compare early responder and non-responders. Logistic regression analysis was used to establish a prediction model. 38.7% of study subjects (124 of 320) responded to paliperidone ER treatment. Logistic regression analysis showed that a good paliperidone ER response was more likely when patients were social drinkers, when patients had started medication at inpatient, when negative symptoms were less severe, and when patients' social relationship and self-care were better. Early response to paliperidone ER treatment is associated with less negative symptoms and good social relationships and self-care. Strategies to reduce these symptoms may contribute to early response to paliperidone ER.Psychiatry investigation 12/2013; 10(4):407-16. DOI:10.4306/pi.2013.10.4.407
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ABSTRACT: Increased levels of alanine aminotransferase (ALT) are a biomarker for metabolic syndrome (MetS), but this relationship remains unproven in patients with schizophrenia. We assessed the relationship between aminotransferase levels and MetS in patients with schizophrenia. This pooled analysis from two open-label prospective studies included 342 patients with schizophrenia who did not meet criteria for MetS at baseline. The development of MetS was assessed at weeks 12 and 24. MetS developed in 19.1 % of patients during the 24-week follow-up period. ALT levels were significantly associated with incident MetS: for each sex-specific standard deviation increase in log ALT, the odds ratio (OR) of MetS was 1.357 (p = .006) after adjusting for age, sex, duration of illness, smoking, and previous use of antipsychotics. This result remained significant after adjusting for interim weight changes. Compared with patients in the lowest quartile, the OR of MetS in those in the highest quartile within the normal range of ALT levels was 4.276 (p = .024). However, this association was significant only in male patients. Using a cutoff value of 23.0 U/L, sensitivity and specificity were 70.6 and 68.3 %, respectively, in male patients whose ALT levels were in the normal range. A prospective association between ALT levels and MetS highlights the value of ALT levels, even mild ALT elevations within the normal range, as a predictor of the MetS risk in male patients. Baseline liver function tests and monitoring should be obtained during antipsychotic treatment to identify the risk for MetS.Psychopharmacology 05/2014; 231(23). DOI:10.1007/s00213-014-3601-7