Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study

Gattaz, Wagner F.; Campos, João Alberto de Oliveira; Lacerda, Acioly L.T.; Henna, Elaine; Ruschel, Sandra Inês; Bressan, Rodrigo A.; Oliveira, Irismar Reis de; Rocha, Fábio Lopes; Grabowski, H; Sacomani, Ernindo; Louzã, Mário Rodrigues; Quevedo, Joao L De; Elkis, Hélio; Filho, Dirceu Zorzetto; Périco, Cíntia de Azevedo-Marques; Lawson, Fábio Lorea; Appolinário, José Carlos

doi:10.1185/03007995.2013.869201

Cited by 6 publications

(6 citation statements)

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“…C min of 9-hydroxyrisperidone was not found to be associated with any neurologic side effects, which could be tentatively explained by a lower affinity to D 2 receptor and a higher affinity to 5-HT2A receptor compared to risperidone [65] . This is also in agreement with prospective studies reporting a decrease of neurologic symptoms after switching from risperidone to 9-hydroxyrisperidone (paliperidone) [66,67] , although more studies are needed to validate the strategy of switching from risperidone to paliperidone in case of poor tolerability. Logistic regression analysis indicated that a C min-active moiety over 40 ng/ml is associated with more than 70% risk to develop neurologic symptoms (figure 3).…”

Section: Discussionsupporting

confidence: 89%

Genetics-Based Population Pharmacokinetics and Pharmacodynamics of Risperidone in a Psychiatric Cohort

et al. 2015

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Section: Discussionsupporting

confidence: 89%

Genetics-Based Population Pharmacokinetics and Pharmacodynamics of Risperidone in a Psychiatric Cohort

et al. 2015

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“…However, the use of an open-label design with a flexible-dose approach more closely reflects actual clinical practice. It should also be noted that in comparison with some recent studies ( Gattaz et al , 2014 ; Kim et al , 2014 ; Schreiner et al , 2014 ), the present study evaluates a smaller sample and the duration of follow-up is shorter, which could limit generalization of the findings. However, it must be taken into account that this is a national study, therefore reflecting a relatively small Italian patient population, and that particular attention has been paid to outcome parameters.…”

Section: Discussionmentioning

confidence: 66%

“…Our data have shown a significant improvement in the total PANSS scores, its subscales, and severity of the symptoms by the CGI-S as well. At the same time, our data are in agreement with recent open-label studies on flexible doses of paliperidone ER in terms of symptomatological and functioning efficacy, safety, and tolerability ( Huang et al , 2012 ; Kim et al ., 2012 ; Schmauss et al , 2012 ; Na et al , 2013 ; Kim et al , 2013 ; Gattaz et al , 2014 ; Schreiner et al , 2014 ). Furthermore, we showed that our patients experienced a significant improvement in functioning, moving from the baseline category of ‘difficulty that interferes on their roles and necessity of support’ (range 51–60, PSP) to an end-point category in which they presented with a difficulty not interfering with their roles (range 61–70, PSP).…”

Section: Discussionmentioning

confidence: 99%

“…Flexible-dose studies therefore enable gathering of more information on the day-to-day use of medication. To date, some studies have been carried out in a flexible-dose design ( Huang et al , 2012 ; Kim et al , 2012 ; Schmauss et al , 2012 ; Na et al , 2013 ; Kim et al , 2013 ; Gattaz et al , 2014 ; Schreiner et al , 2014 ), but only two of them ( Kim et al , 2013 ; Schreiner et al , 2014 ) also used general measures of psychopathology, functioning, and well-being for a direct transition from a variety of oral antipsychotics to flexibly dosed paliperidone ER.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics

Mauri

Adami³

et al. 2015

International Clinical Psychopharmacology

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This study evaluates the effectiveness of paliperidone ER in patients with symptomatic but not highly acute schizophrenia in terms of efficacy, safety, and patients’ perception of their social functioning and well-being. This is a multicenter, open-label prospective study with a flexible-dose approach; 133 patients were enrolled and followed for 13 weeks after switching to paliperidone ER. Outcome efficacy measures were as follows: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale; in addition, the Subjective Well-being under Neuroleptics (SWN-20) scale, the Drug Attitude Inventory (DAI-30), and the sleep evaluation scale were used. Symptom Rating Scale (ESRS), adverse events, and subjective side effects were recorded. 118/133(88.7%) patients completed the study. The mean PANSS score decreased (88.98±10.09 to 66.52±16.29; P<0.001); 40.5% of the patients achieved improvement of at least 30%. PSP and CGI-S scores as well as DAI-30 and SWN-20 decreased (P<0.001). ESRS (P<0.001) decreased significantly from the baseline. Throughout the trial, no deaths occurred and only one serious adverse event was reported. Paliperidone ER has proved to be efficacious, safe, and well tolerated also with this approach more closely resembling actual clinical practice. Patient-relevant outcome parameters such as social functioning and quality of life improved, which is crucial for treatment adherence in clinical practice.

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“…Given the importance of HRQoL in patients with schizophrenia, long-term studies can provide a broader picture of antipsychotic effectiveness in clinical practice. While results from clinical trials indicate that switching between antipsychotics can be performed in a relatively safe manner [ 20 , 25 – 31 ], only a few studies have reported on the long-term (>6 months) effects of switching between treatments on HRQoL, patient attitude towards medication, or health status [ 25 , 29 , 32 – 36 ].…”

Section: Introductionmentioning

confidence: 99%

Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia

et al. 2016

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BackgroundLong-term improvement of health-related quality of life (HRQoL) in schizophrenia may improve adherence and reduce relapse and rehospitalization. This analysis examines long-term changes in HRQoL among patients with schizophrenia switched to lurasidone from other antipsychotics.MethodsPatients who completed an open-label 6-week switch study continued on lurasidone for an additional 24-weeks. HRQoL was measured using the self-reported Personal Evaluation of Transitions in Treatment (PETiT) scale and Short-Form 12 (SF-12) questionnaire. The PETiT assessed HRQoL via total and domain scores (adherence-related attitude and psychosocial functioning). The SF-12 assessed patients’ mental and physical component summary scores (MCS and PCS). Mean changes from the initial baseline were calculated at extension baseline and extension endpoint using analysis of covariance models. Analyses were further stratified by prior antipsychotic medication and responder status; responders were defined as having a ≥20 % improvement in Positive and Negative Syndrome Scale during the first 6-weeks of treatment.ResultsThe analysis included 144 patients with PETIT or SF-12 data who received ≥1 dose of lurasidone. Mean (standard deviation) PETiT total score improved significantly from 34.9 (9.3) at baseline to 39.5 (8.9) at extension baseline and 39.1 (9.0) at extension endpoint, representing improvements of 4.5 (7.9) and 5.1 (7.2) points, respectively (both p < 0.001). Significant improvements in adherence-related attitude and psychosocial functioning were observed at extension baseline and extension endpoint (all p < 0.001). Improvement in SF-12 MCS score was observed at extension baseline and endpoint, and PCS score at extension endpoint (all p < 0.01). Patients who switched from quetiapine and aripiprazole showed significant improvement of PETiT total score and adherence-related attitude at extension baseline and extension endpoint. In addition, patients who switched from quetiapine, risperidone, aripiprazole, or ziprasidone showed significant improvement in MCS scores from baseline to extension endpoint. Responders to lurasidone demonstrated greater improvement in PETiT total, psychosocial functioning, and MCS scores at extension baseline than nonresponders.ConclusionsAfter switching to lurasidone, patients with schizophrenia experienced HRQoL improvements that were sustained for an additional 24 weeks of treatment. Further study is warranted to understand the implications of these improvements in terms of employment, adherence, relapse, and rehospitalization.Trial registrationClinical trials.gov identifier NCT01143090 (June 10th, 2010).

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Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study

Cited by 6 publications

References 19 publications

Genetics-Based Population Pharmacokinetics and Pharmacodynamics of Risperidone in a Psychiatric Cohort

Genetics-Based Population Pharmacokinetics and Pharmacodynamics of Risperidone in a Psychiatric Cohort

Efficacy and tolerability of paliperidone ER in patients with unsatisfactorily controlled schizophrenia by other antipsychotics

Long-term health-related quality of life improvements among patients treated with lurasidone: results from the open-label extension of a switch trial in schizophrenia

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