Evidence map›Paper›PMID 29764266›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2018

Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence.

Tianmei Si, Nan Li, Huafei Lu, Shangli Cai, Jianmin Zhuo, Christoph U Correll, Lili Zhang, Yu Feng

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 25% of its field
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
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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

8 authors at 4 institutions in 3 countries.

Tianmei Si1 National Clinical Research Center for Mental Disorders & The Key Laboratory of Mental Health, Ministry of Health, Beijing, People's Republic of China.
Nan Li3 Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, People's Republic of China.
Huafei Lu4 Xian Janssen Pharmaceutical Ltd, Beijing, People's Republic of China.
Shangli Cai4 Xian Janssen Pharmaceutical Ltd, Beijing, People's Republic of China.
Jianmin Zhuo5 Johnson & Johnson (China) Investment Ltd, Shanghai, People's Republic of China.
Christoph U Correll6 Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, USA.
Lili Zhang4 Xian Janssen Pharmaceutical Ltd, Beijing, People's Republic of China.
Yu Feng8 Janssen Pharmaceutical Companies, Johnson and Johnson, Singapore.ORCID 0000-0002-3089-2375
Peking University · CNHofstra University · USJohnson Electric (China) · CNJohnson & Johnson (Singapore) · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLimited data are available to help identify patients with schizophrenia who are most likely to benefit from long-acting injectable antipsychotics.

aimTo investigate the efficacy of long-acting injectable antipsychotic paliperidone palmitate one-month formulation for preventing relapses, factors influencing time to first relapse, and the effect of different antipsychotic adherence levels on time to first relapse in Chinese patients with schizophrenia.

methodsThis was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75-150 mg eq.) or switching to another antipsychotic(s).

resultsThere were 362/367 patients (age=31.4±10.75 years) included in the analysis of time to first relapse (primary outcome) and 327/362 patients (39/327, poor antipsychotic adherence (<80%)) willing to receive antipsychotics were included in the exposure/adherence analysis. Overall, 84.6% (95% confidence interval=79.2-88.7) patients remained relapse-free. Poor adherence during follow-up (hazard ratio=2.97, 95% confidence interval=1.48-5.98, p=0.002) and frequent hospitalizations in the previous year (hazard ratio=1.29, 95% confidence interval=1.02-1.62, p=0.03) were associated with a significant risk of shorter time to first relapse in the univariate analysis. In patients with poor adherence, 'no use' (hazard ratio=13.13, 95% confidence interval=1.33-129.96, p=0.03) and 'interrupted use' (hazard ratio=11.04, 95% confidence interval=1.03-118.60, p=0.047) of paliperidone palmitate one-month formulation (vs continued use) showed a significantly higher risk of relapse; this was not observed in patients with good (≥80%) antipsychotic adherence. No new safety concerns were identified.

conclusionContinued use of paliperidone palmitate one-month formulation/long-acting injectable antipsychotic was effective in preventing schizophrenia relapses, especially in patients with suboptimal antipsychotic adherence.

Indexed as

Drug MonitoringAdultAntipsychotic AgentsDelayed-Action PreparationsFemaleFollow-Up StudiesHospitalizationHumansInjectionsMalePaliperidone PalmitateRecurrenceSchizophreniaSecondary PreventionTime FactorsTreatment OutcomeAntipsychotic AgentsDelayed-Action PreparationsPaliperidone PalmitateAdherencelong-acting injectable antipsychoticpaliperidone palmitatePositive and Negative Syndrome Scalerelapse preventionschizophrenia

Identifiers

PMID29764266
PMCPMC6024380
OpenAlexW2803457478

What OpenQuestion holds

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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.