An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

Parellada, Eduard; Bioque, Miquel; Serrano, Manuel; Herrera, Berta Loja

doi:10.1080/13651501.2017.1404112

Cited by 3 publications

(3 citation statements)

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“…Como régimen de inicio de tratamiento se recomiendan inyecciones en deltoides de 150 mg y de 100 mg el octavo día (± 4) con el fin de alcanzar rápidamente concentraciones plasmáticas en rango terapéutico, seguidas por inyecciones mensuales de administración glútea o deltoides 31 . La suplementación oral no es necesaria, aunque algunos pacientes podrían beneficiarse 32 . En el año 2015 una revisión de nuestro grupo identificó 18 estudios de PP1M, reportando la superioridad del PP1M respecto a placebo y resultados similares de eficacia y tolerabilidad en comparación con la RILD o la paliperidona oral 33 .…”

Section: Palmitato De Paliperidona Mensualunclassified

“…En un reciente estudio multicéntrico, abierto, prospectivo y observacional, el PP1M resultó ser eficaz y bien tolerado para tratar fases agudas de esquizofrenia, tanto solo como combinado con otros antipsicóticos 32 . Por último, una revisión reciente de estudios de real-world data (procedentes de estudios observacionales y ECA pragmáticos) indicó que el PP1M es superior a los antipsicóticos orales en retrasar el fracaso terapéutico o las recaídas 34 .…”

Section: Palmitato De Paliperidona Mensualunclassified

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Antipsicóticos inyectables de larga duración

Bioque¹,

García-Rizo²,

Garriga³

2019

RPSIC

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Los antipsicóticos inyectables de larga duración supusieron un cambio de paradigma en el tratamiento de los trastornos psicóticos con reticencias iniciales de terapeutas, pacientes y familiares que perduran hasta la actualidad. La efectividad en la prevención de recaídas asociada a un perfil de efectos secundarios más tolerable que las formulaciones orales ha permitido ampliar las recomendaciones terapéuticas. La retirada de tratamientos de primera generación en los últimos años junto con nuevas formulaciones de segunda generación permitirá una variabilidad terapéutica más acorde con las prescripciones orales. Un conocimiento más exhaustivo de las características de los inyectables de larga duración en nuestro entorno por parte de prescriptores y otros terapeutas, así como mayor difusión a familiares y pacientes, permitirá a estos últimos beneficiarse de las potenciales ventajas del tratamiento antipsicótico inyectable de larga duración.

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Section: Palmitato De Paliperidona Mensualunclassified

Antipsicóticos inyectables de larga duración

Bioque¹,

García-Rizo²,

Garriga³

2019

RPSIC

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“…Their use has been associated to a 30% decrease in mortality risk [17]. In concrete, paliperidone palmitate, either in 1-month or three-month formulation, have shown to be effective to reduce the number of relapses related to treatment lack of adherence, both in the short-and in the long term [2,[18][19][20][21]. However, despite LAI antipsychotics have documented their value for preventing relapses, they are significantly underused due to different barriers [16,[22][23][24][25][26].…”

Section: Introductionmentioning

confidence: 99%

Clozapine and paliperidone palmitate antipsychotic combination in treatment-resistant schizophrenia and other psychotic disorders: A retrospective 6-month mirror-image study

et al. 2020

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Background: Around 30% of patients with schizophrenia are considered treatment resistant (TRS). Only around 40% of TRS patients respond to clozapine. Long acting injectable antipsychotics could be a useful augmentation strategy for nonresponders. Methods: We conducted a multicenter, observational, naturalistic, retrospective, 6-month mirror-image study to evaluate the efficacy and tolerability of clozapine and paliperidone palmitate association in 50 patients with TRS and other psychotic disorders. Clinical outcomes and side effects were systematically assessed. Results: Six months after starting the combined treatment, participants showed a significant relief of symptoms, decreasing the Brief Psychiatric Rating Scale total score from 18.32 ± 7.71 to 7.84 ± 5.16 (p < 0.001). The number of hospitalizations, the length of hospital stays and the number of visits to emergency services also decreased, while an increase of the functionality was observed (Personal and Social Performance total score increased from 46.06 ± 118.7 to 60.86 ± 18.68, p < 0.001). There was also a significant decrease in the number and severity of side effects with the combination therapy, decreasing the Udvalg for Kliniske Undersogelser total score from 10.76 ± 8.04 to 8.82 ± 6.63 (p = 0.004). Conclusions: This study provides the first evidence that combining clozapine with paliperidone palmitate in patients with TRS and other psychotic disorders could be effective and safe, suggesting further research with randomized controlled trials of augmentation strategies for clozapine nonresponder patients. Policy Significance Statement: Patients with psychotic disorders such as schizophrenia show a variable response to antipsychotic treatments. Around 30% of patients are considered treatment resistant, indicated by insufficient symptom control to at least two different drugs. In these resistant cases, clozapine should be indicated, as it has shown to be superior to other options. However, only 40% of patients respond to clozapine, being necessary to establish which treatments could best potentiate clozapine action. Combining clozapine with long acting injectable antipsychotics, and particularly paliperidone palmitate, could be a useful strategy. We conducted a multicenter study of 50 patients with treatment-resistant schizophrenia and other psychotic disorders comparing the efficacy and tolerability in the 6 month-period prior and after starting the clozapine and paliperidone palmitate association. Our study suggests that this combination could be effective and safer, laying the groundwork for future clinical trials with this combination.

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The current data on the 3-month paliperidone palmitate formulation for the treatment of schizophrenia

Bioque

Bernardo

2018

Expert Opinion on Pharmacotherapy

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An open-treatment six-week study of the clinical effectiveness of Paliperidone Palmitate in schizophrenia: data from acute units in Spain (SHADOW study)

Abstract: PP1M was effective and well tolerated in treatment of acute episodes of schizophrenia both in monotherapy and in combination with other antipsychotics in clinical setting. Early start of PP1M therapy in acute schizophrenia episodes might help to shorten hospital stay.

Cited by 3 publications

References 49 publications

Antipsicóticos inyectables de larga duración

Antipsicóticos inyectables de larga duración

Clozapine and paliperidone palmitate antipsychotic combination in treatment-resistant schizophrenia and other psychotic disorders: A retrospective 6-month mirror-image study

The current data on the 3-month paliperidone palmitate formulation for the treatment of schizophrenia

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