Evidence map›Paper›PMID 30994855›Full record

Trial reportRevista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)

Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies.

Adam J Savitz, Haiyan Xu, Srihari Gopal, Isaac Nuamah, Maju Mathews, Bernardo Soares

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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
–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.

NCT01515423 phase3completednot on this map

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

TypeinterventionalSponsorJanssen Research & Development, LLCRan2012 to 2015Enrolled1,429ConditionsSchizophreniaArmsPP3M 175 mg eq., PP3M 263 mg eq., PP3M 350 mg eq., PP3M 525 mg eq., Placebo (20% Intralipid)
NCT01529515 phase3completednot on this map

A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia

TypeinterventionalSponsorJanssen Research & Development, LLCRan2012 to 2014Enrolled509ConditionsSchizophreniaArmsPP3M 175 mg eq., PP3M 263 mg eq., PP3M 350 mg eq., PP3M 525 mg eq., Placebo (20% Intralipid emulsion)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Paliperidone to Treat Psychotic Disorders.Neurology international · 2021
    Review
  7. Review
  8. 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

6 authors.

Adam J SavitzJanssen Research & Development, LLC, Pennington, NJ, USA.ORCID http://orcid.org/0000-0001-8868-3704
Haiyan XuJanssen Research & Development, LLC, Pennington, NJ, USA.
Srihari GopalJanssen Research & Development, LLC, Pennington, NJ, USA.
Isaac NuamahJanssen Research & Development, LLC, Pennington, NJ, USA.
Maju MathewsJanssen Research & Development, LLC, Titusville, NJ, USA.
Bernardo SoaresJanssen-Cilag UK, Buckinghamshire, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW).

methodsWe analyzed data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizophrenia (DSM-IV-TR) previously stabilized on PP1M/PP3M (open-label [OL] phase). Patients were randomized to PP3M or PP1M (noninferiority study A) and PP3M or placebo (study B) in DB phase. The subgroup analysis included Latin American (Argentina, Brazil, Colombia, Mexico) patients. Primary efficacy endpoints were relapse-free rates (study A) and time-to-relapse (study B).

resultsIn study A, 63/71 (88.7%) and in study B 38/43 (88.4%) Latin American patients completed the DB phase. In study A, relapse-free percentage was similar in Latin America (PP3M: 97%, PP1M: 100%) and ROW (PP3M: 91%, PP1M: 89%). In study B, median time-to-relapse was not estimable in the Latin American subgroup for either placebo or PP3M groups, nor for the ROW PP3M group; the median time-to-relapse in the ROW placebo group was 395 days. Caregiver burden improved in patients switching from oral antipsychotics (OL baseline) to PP3M/PP1M in DB phase (Involvement Evaluation Questionnaire score mean ± SD change, -9.4±15.16; p < 0.001). Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70.6%]; study B: 15/21 [71.4%]) and ROW (study A: 318/470 [67.7%]; study B: 84/139 [60.4%]) subgroups.

conclusionPP3M was efficacious and showed no new safety concerns in patients with schizophrenia from Latin America, corroborating ROW findings. CLINICAL

trial registrationNCT01515423, NCT01529515.

Indexed as

AdolescentAdultAgedAntipsychotic AgentsDouble-Blind MethodFemaleHumansKaplan-Meier EstimateLatin AmericaMaleMiddle AgedPaliperidone PalmitatePlacebo EffectRecurrenceReproducibility of ResultsSchizophreniaAntipsychotic AgentsPaliperidone Palmitate

Identifiers

PMID30994855
PMCPMC6899357

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.