Symptomatic remission in schizophrenia patients treated with aripiprazole or haloperidol for up to 52 weeks

Bristol-Myers Squibb, New York, New York, United States
Schizophrenia Research (Impact Factor: 3.92). 09/2007; 95(1-3):143-50. DOI: 10.1016/j.schres.2007.05.009
Source: PubMed


The Remission in Schizophrenia Working Group (RSWG) has defined criteria for symptomatic remission based on achieving and maintaining a consistently low symptom threshold for at least six consecutive months. This analysis examined symptomatic remission in acutely ill patients with schizophrenia receiving either aripiprazole or haloperidol for one year.
Pooled data from two 52-week, randomized, double-blind, multicenter, comparative trials of aripiprazole and haloperidol in acutely ill patients with schizophrenia were analyzed. Measures of symptomatic remission were calculated according to RSWG criteria.
Remission rates were significantly higher for patients treated with aripiprazole compared with haloperidol (32% vs 22%, respectively; p<0.001, LOCF). Among remitters, aripiprazole-treated patients achieved symptom criteria in a significantly shorter time than haloperidol-treated patients (log rank p=0.0024). For trial completers, remission rates were similarly high in both groups (aripiprazole, 77%; haloperidol, 74%). Regardless of treatment type, remitters received significantly higher global clinical ratings than nonremitters (p<0.0001). Aripiprazole was associated with a significantly lower rate of discontinuations due to adverse events (AEs) than haloperidol (8.0% vs 18.4%, respectively; p<0.001) as well as lower concomitant medication use for extrapyramidal symptoms (EPS) (23% vs 57%, respectively; p<0.001).
Acutely ill schizophrenia patients treated with aripiprazole demonstrated a significantly higher rate of symptomatic remission across 52 weeks compared with haloperidol-treated patients. The similar remission rates among trial completers in both treatment groups, combined with fewer AE-related discontinuations and lower EPS medication use in the aripiprazole group, suggest that better tolerability with aripiprazole may have contributed to superior overall remission rates.

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Available from: James M Eudicone, Jun 02, 2015
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    • "Baseline, weekly for 6 weeks, then 3 and 6 months Kane et al. (2007) 43 Aripiprazole, "
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    ABSTRACT: In 2005, the Remission in Schizophrenia Working Group published consensus criteria to define remission. These criteria have been widely accepted and utilized and have provided further insights about schizophrenia management and prognosis. We systematically reviewed studies that utilized these criteria, with the aim of assessing the remission rate in follow-up studies and the variables predicting or associated with remission. Remission has a reported rate of 17% to 78% (weighted mean = 35.6%) in first-episode schizophrenia and 16% to 62% (weighted mean = 37%) in multiple-episode patients, with no statistical difference between the two weighted means (p = .79). Patients who were treated with long-acting injectable risperidone showed high maintenance of remission status. Studies comparing second-generation antipsychotics versus haloperidol showed higher remission rates for the former. The variables most frequently associated with remission were better premorbid function, milder symptoms at baseline (especially negative symptoms), early response to treatment, and shorter duration of untreated psychosis. Variability in the length and frequency of follow-ups, as well as differences in dropout rates, could partially explain the differences in reported rates. Rates of symptomatic remission exceeded reported rates for functional recovery. Moreover, the majority of studies used Remission in Schizophrenia Working Group severity criteria only, neglecting duration. To enhance comparison between future research findings, we suggest further specifiers of the working group's criteria, to better define frequency and duration of follow-up, and proxy measures of remission.
    Full-text · Article · Nov 2012 · Harvard Review of Psychiatry
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    • "The Remission in Schizophrenia Working Group (RSWG) chose 8 items of PANSS (delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity) as determinants for the definition of remission [6]. Several studies have already implemented this concept and found that patients achieving remission status had better performance in neuropsychological tests and greater social and occupational functions [7-9]. On the other hand, functionality became an important focus of treatment in psychotic patients. "
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    ABSTRACT: We aimed to explore relations between symptomatic remission and functionality evaluation in schizophrenia patients treated with paliperidone extended-release (ER), as seen in a normal day-to-day practice, using flexible dosing regimens of paliperidone ER. We explored symptomatic remission rate in patients treated with flexibly dosed paliperidone ER by 8 items of Positive and Negative Syndrome Scale (PANSS) and change of Personal and Social Performance (PSP) scale. This was a 12-week multicenter, open-label, prospective clinical study conducted in in-patient and out-patient populations. Flexible dosing in the range 3-12 mg/day was used throughout the study. All subjects attended clinic visits on weeks 0, 4, 8, and 12 as usual clinical practice for the 12-week observation period. Data were summarized with respect to demographic and baseline characteristics, efficacy measurement with PANSS scale, PSP, and social functioning score, and safety observations. Descriptive statistics were performed to identify the retention rate at each visit as well as the symptomatic remission rate. Summary statistics of average doses the subjects received were based on all subjects participating in the study. A total of 480 patients were enrolled. Among them, 426 patients (88.8%) had evaluation at week 4 and 350 (72.9%) completed the 12-week evaluation. Patients with at least moderate severity of schizophrenia were evaluated as "mild" or better on PANSS scale by all 8 items after 12 weeks of treatment with paliperidone ER. There was significant improvement in patients' functionality as measured by PSP improvement and score changes. Concerning the other efficacy parameters, PANSS total scale, PSP total scale, and social functioning total scale at the end of study all indicated statistically significant improvement by comparison with baseline. The safety profile also demonstrated that paliperidone ER was well-tolerated without clinically significant changes after treatment administration. Although the short-term nature of this study may limit the potential for assessing improvements in function, it is noteworthy that in the present short-term study significant improvements in patient personal and social functioning with paliperidone ER treatment were observed, as assessed by PSP scale. Clinical Trials. PAL-TWN-MA3.
    Full-text · Article · Jan 2012 · BMC Clinical Pharmacology
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    • "Validation of the international remission criteria was made in naturalistic [5-7] and intervention [8,9] studies. De Hert et al. [5] evaluated the maintenance of remission over 1 year in a large naturalistic prospective study: 99 (29%) of the 341 patients met full remission criteria at the end point, whereas 147 (43%) patients did not meet the symptomatic criterion. "
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    ABSTRACT: A standardized definition of remission criteria in schizophrenia was proposed by the International group of NC Andreasen in 2005 (low symptom threshold for the eight core Positive and Negative Syndrome Scale (PANSS) symptoms for at least 6 consecutive months). A cross-sectional study of remission rate, using a 6-month follow-up to assess symptomatic stability, was conducted in two healthcare districts (first and second) of an outpatient psychiatric service in Moscow. The key inclusion criteria were outpatients with an International Classification of Diseases, 10th edition (ICD-10) diagnosis of schizophrenia or schizoaffective disorder. Remission was assessed using modern criteria (severity and time criteria), PANSS and Global Assessment of Functioning (GAF). Patients who were stable but did not satisfied the symptomatic criteria were included in a further 1-year observational study, with the first group (first district) receiving risperidone (long-acting, injectable) (RLAI) and the second group (second district) continuing to receiving routine treatment. Symptoms were assessed with PANSS, social functioning with the personal and social performance scale, compliance with rating of medication influences scale, and extrapyramidal side effects with the Simpson-Angus scale. Only 64 (31.5%) of 203 outpatients met the criteria for symptomatic remission in the cross-sectional study, but at the end of the 6-month follow-up period, 158 (77.8%) were stable (irrespective of remission status). Among these only 53 (26.1%) patients fulfilled the remission criteria. The observational study had 42 stable patients in the RLAI group and 35 in the routine treatment group: 19.0% in the RLAI group and 5.7% in the control group met remission criteria after 12 months of therapy. Furthermore, reduction of PANSS total and subscale scores, as well as improvement in social functioning, was more significant in the first group. Only around one-quarter of our outpatient schizophrenic population met full remission criteria. Use of RLAI gave a better remission rate than achieved in standard care with routine treatment. Criteria for remission should take into account clinical course and functioning to support clinical care.
    Full-text · Article · Jan 2012 · Annals of General Psychiatry
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