Evidence map›Paper›PMID 40104335›Full record

ArticleFrontiers in psychiatry2025

Long-term effectiveness, adherence and safety of twice-yearly paliperidone-palmitate long acting-injectable in patients with schizophrenia in Europe: 2-year mirror-image data from the paliperdone-2 per year study (P2Y).

Sofía Manchado Perero, Ana Rodríguez Lorente, Alba García-Pérez, Guillermo Isidro García, Luis Alberto Forcen-Muñoz, Santiago Ovejero García, Rocío Sáez Povedano, Ana Luisa González-Galdámez, Laura Mata Iturralde, Mariluz Ramirez Bonilla and 15 more

Abstract read
In one paragraph

Article in Frontiers in psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Sofía Manchado PereroDepartment of Psychiatry, Fundación Jiménez Díaz University Hospital, Madrid, Spain.
Ana Rodríguez LorenteDepartment of Psychiatry, Santa Lucía University Hospital, Cartagena, Murcia, Spain.
Alba García-PérezCentre of Mental Health Molina de Segura, Molina de Segura, Murcia, Spain.
Guillermo Isidro GarcíaDepartment of Psychiatry, Marqués de Valdecilla University Hospital, Universidad de Cantabria, Santander, Spain.
Luis Alberto Forcen-MuñozCentre of Mental Health Lorca, Lorca, Murcia, Spain.
Santiago Ovejero GarcíaDepartment of Psychiatry, Fundación Jiménez Díaz University Hospital, Madrid, Spain.
Rocío Sáez PovedanoDepartment of Psychiatry, General Hospital de Villarrobledo, Villarrobledo, Albacete, Spain.
Ana Luisa González-GaldámezDepartment of Psychiatry, Los Arcos-Mar Menor University Hospital, San Javier, Murcia, Spain.
Laura Mata IturraldeDepartment of Psychiatry, Fundación Jiménez Díaz University Hospital, Madrid, Spain.
Mariluz Ramirez BonillaDepartment of Psychiatry, Marqués de Valdecilla University Hospital, Universidad de Cantabria, Santander, Spain.
Paloma Fuentes-PérezPsychiatry and Mental Health Research Group, Instituto Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain.
Claudia Ovejas-CatalánPsychiatry and Mental Health Research Group, Instituto Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain.
Paula Suárez-PinillaDepartment of Psychiatry, Marqués de Valdecilla University Hospital, Universidad de Cantabria, Santander, Spain.
Blanca Fernández AbascalDepartment of Psychiatry, Marqués de Valdecilla University Hospital, Universidad de Cantabria, Santander, Spain.
Miguel Omaña ColmenaresDepartment of Psychiatry, Alcanyis General Hospital, Xátiva, Valencia, Spain.
María Pilar Campos-NavarroDepartment of Psychiatry, Santa Lucía University Hospital, Cartagena, Murcia, Spain.
Enrique Baca-GarcíaDepartment of Psychiatry, Fundación Jiménez Díaz University Hospital, Madrid, Spain.
Ana Lara FernándezDepartment Psychiatry, Infanta Elena University Hospital, Madrid, Spain.
Sergio Benavente-LópezDepartment Psychiatry, Infanta Elena University Hospital, Madrid, Spain.
Alberto Raya PlateroDepartment of Psychiatry, San Cecilio Clinic Hospital, Granada, Spain.
Miguel Barberán NavalónDepartment of Psychiatry, Alcanyis General Hospital, Xátiva, Valencia, Spain.
Sergio Sánchez-AlonsoDepartment of Psychiatry, Fundación Jiménez Díaz University Hospital, Madrid, Spain.
Javier Vázquez-BourgonDepartment of Psychiatry, Marqués de Valdecilla University Hospital, Universidad de Cantabria, Santander, Spain.
Sofia Pappa *West London National Health System (NHS) Trust, London, United Kingdom.
Juan Antonio García-Carmona *Department of Neurology, Santa Lucía University Hospital, Cartagena, Murcia, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: LAIs with longer dosing intervals appear to be associated with improved clinical outcomes and added real-world benefits in the management of schizophrenia. Paliperidone palmitate six-monthly (PP6M) LAI provides the longest dosing interval, twice-yearly dosing, among all currently available LAIs. In clinical trials PP6M was found to be non-inferior in preventing relapses in patients with schizophrenia compared to the three monthly formulation (PP3M) though real world data remain limited. Therefore, the aim of this study was to evaluate the acceptability, effectiveness, and safety of PP6M in patients with schizophrenia in real world practice. Methods: Data were derived from a naturalistic cohort of patients enrolled in the international, multicenter, prospective Paliperidone-2-per Year (P2Y) study. In this 2-year mirror-image study we compare the number of hospital admissions 1 year pre- and post-PP6M initiation as well as the CGI scores at baseline and the point of each PP6M administration. Discontinuation rates and reasons were also collected. Results: A total of 201 patients (107 outpatients and 94 chronic long-stay inpatients) were included. The majority of patients had switched to PP6M from either PP3M (76%) or PP1M (19%) while the 3% switched from aripiprazole 1-monthly and the 2% from risperidone-LAI and zuclopenthixol-LAI. The mean CGI-Severity score significantly reduced from baseline to the second and third PP6M administrations in the global cohort (2.31 ± 0.14 Conclusions: This is the first mirror-image study in patients with schizophrenia treated with PP6M in real-world settings showing very high treatment persistence, reduced hospital admissions compared to previous LAIs and no major safety concerns. Our findings suggest that six-monthly treatment with a long-acting antipsychotic may confer additional benefits in the management of schizophrenia. Nonetheless, we were unable to determine the precise changes in symptoms. Therefore, future studies are needed to truly establish the role of PP6M.

Indexed as

CGI (Clinical Global Impressions)hospital admissionlong-acting injectable antipsychoticsmirror-image studypaliperidone-palmitate 6-monthlyschizophreniaside effect analysis

Identifiers

PMID40104335
PMCPMC11913845

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.