Evidence map›Paper›PMID 26813484›Full record

ArticleJournal of psychiatric practice2016

A Flexible-Dose Study of Paliperidone ER in Patients With Nonacute Schizophrenia Previously Treated Unsuccessfully With Oral Olanzapine.

Moshe Kotler, Nesrin Dilbaz, Fernanda Rosa, Periklis Paterakis, Vihra Milanova, Anatoly B Smulevich, Marjolein Lahaye, Andreas Schreiner

Open access · hybridAbstract read
In one paragraph

Article in Journal of psychiatric practice, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

8 authors at 7 institutions in 8 countries.

Moshe KotlerKOTLER: Beer Yaakov-Ness Ziona Mental Health Center, Beer Yaakov, Israel; and Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel DILBAZ: Üsküdar University Neuropsychiatry Hospital, Istanbul, Turkey PATERAKIS: Hospital Dromokaiteio Therapeftirio, Chaidari, Athens, Greece MILANOVA: Department of Psychiatry, Medical University, Sofia, Bulgaria SMULEVICH: Research Clinical Department of Boundary Conditions and Psychosomatic Disorders, Mental Health Research; and Department of Psychiatry and Psychosomatics, I.M. Sechenov First Moscow Stare Medical University, Moscow, Russia LAHAYE: Medical Affairs EMEA, Janssen-Cilag BV, Tilburg, The Netherlands SCHREINER: Medical and Scientific Affairs EMEA, Janssen-Cilag GmbH, Neuss, Germany.
Nesrin Dilbaz
Fernanda Rosa
Periklis Paterakis
Vihra Milanova
Anatoly B Smulevich
Marjolein Lahaye
Andreas Schreiner
Janssen (Netherlands) · NLBristol-Myers Squibb (United States) · USCreative Commons · USMedical University of Sofia · BGMental Health Research Institute · AUSechenov University · RUTel Aviv University · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe goal of this study was to explore the tolerability, safety, and treatment response of switching from oral olanzapine to paliperidone extended release (ER).

methodsAdult patients with nonacute schizophrenia who had been treated unsuccessfully with oral olanzapine were switched to flexible doses of paliperidone ER (3 to 12 mg/d). The primary efficacy outcome was a ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to endpoint for patients who switched medications because of lack of efficacy with olanzapine and noninferiority versus previous olanzapine treatment (mean endpoint change in PANSS total scores vs. baseline of ≤ 5 points) for patients who switched for reasons other than lack of efficacy. Safety and tolerability were assessed by monitoring adverse events, extrapyramidal symptoms, and weight change.

resultsOf 396 patients, 65.2% were men, mean age was 40.0 ± 12.0 years, and 75.5% had paranoid schizophrenia. Among the patients whose main reason for switching was lack of efficacy, an improvement in the PANSS total score of ≥ 20% occurred in 57.4% of patients. Noninferiority was confirmed for each subgroup of patients whose main reason for switching was something other than lack of efficacy. Paliperidone ER was generally well tolerated. Extrapyramidal symptoms as measured by total Extrapyramidal Symptom Rating Scale scores showed statistically significant and clinically relevant improvements at endpoint, the average weight decreased by 0.8 ± 5.2 kg at endpoint, and a clinically relevant weight gain of ≥ 7% occurred in 8.0% of patients.

conclusionPaliperidone ER flexibly-dosed over 6 months was well tolerated and associated with a meaningful clinical response in patients with nonacute schizophrenia who had previously been unsuccessfully treated with oral olanzapine.

Indexed as

Administration, OralAdultAntipsychotic AgentsBenzodiazepinesDelayed-Action PreparationsFemaleHumansMaleMiddle AgedOlanzapinePaliperidone PalmitatePsychiatric Status Rating ScalesSchizophreniaTreatment FailureAntipsychotic AgentsBenzodiazepinesDelayed-Action PreparationsOlanzapinePaliperidone Palmitate

Identifiers

PMID26813484
PMCPMC4770270
OpenAlexW2410770465

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.