Evidence map›Paper›PMID 32606705›Full record

ArticleNeuropsychiatric disease and treatment2020

Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies.

Maju Mathews, Srihari Gopal, Arun Singh, Isaac Nuamah, Katalin Pungor, Wilson Tan, Bernardo Soares, Edward Kim, Adam J Savitz

Open access · goldAbstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

13 citing papers in PubMed, 22 citations in OpenAlex.

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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

9 authors at 3 institutions in 3 countries.

Maju MathewsGlobal Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA.
Srihari GopalDepartment of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.ORCID 0000-0001-5254-2192
Arun SinghDepartment of Neuroscience, Janssen Research & Development, LLC, Pennington, PA, USA.ORCID 0000-0002-9567-6139
Isaac NuamahClinical Biostatistics, Janssen Research & Development, LLC, Titusville, NJ, USA.
Katalin PungorMedical Affairs, Janssen-Cilag GmbH, Neuss, North Rhine-Westphalia, Germany.ORCID 0000-0003-4679-2050
Wilson TanRegional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore.ORCID 0000-0003-4832-156X
Bernardo SoaresMedical Affairs, Jan-Cil, High Wycombe, Buckinghamshire, UK.
Edward KimJanssen Scientific Affairs, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.ORCID 0000-0001-8247-6675
Adam J SavitzDepartment of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.
Janssen (United States) · USJanssen (Germany) · DEJohnson & Johnson (Singapore) · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents.

objectiveTo compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables).

methodsData from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed.

resultsIn total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M <PP1M <paliperidone and ER, in both the active treatment (PP3M, 9% <PP1M, 18% <paliperidone ER, 22%) and placebo (PP3M, 29% <PP1M, 48% <paliperidone ER, 52%) groups. The post-discontinuation median-time-to-relapse was significantly longer with PP3M (395 days [274 days to "not-reached"])> PP1M (172 days [134-222 days])> paliperidone ER (58 days [42-114 days]) and was "not-estimable" in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P<0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P<0.001]).

conclusionThe lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence.

Indexed as

oral paliperidone extended releasepaliperidone palmitate once monthlypaliperidone palmitate three monthlyrelapse preventionschizophrenia

Identifiers

PMID32606705
PMCPMC7311166
OpenAlexW3036040035

What OpenQuestion holds

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LicenceCC BY-NC
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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.