Evidence map›Paper›PMID 29719399›Full record

ArticleNeuropsychiatric disease and treatment2018

Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia.

Hideaki Katagiri, Masanori Taketsuna, Shinpei Kondo, Kenta Kajimoto, Etsuko Aoi, Yuka Tanji

Abstract read
In one paragraph

Article in Neuropsychiatric disease and treatment, 2018. 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. Review
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  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

6 authors.

Hideaki KatagiriBio-Medicines, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Masanori TaketsunaStatistical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Shinpei KondoPost Marketing Study Management, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Kenta KajimotoScientific Communications, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Etsuko AoiGlobal Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., Kobe, Japan.
Yuka TanjiBio-Medicines, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine (RAIM) in patients with acute agitation associated with schizophrenia in a real-world clinical setting.

methodsThe postmarketing surveillance study with a 3-day observational period after the last RAIM administration was conducted (original study). Following this, an extended study was added for patients who received oral olanzapine after RAIM administration during the original study period, in order to additionally observe them for 7 days after initial RAIM administration. Effectiveness and safety from initial RAIM administration were evaluated using the Positive and Negative Syndrome Scale-Excited Component score and treatment-emergent adverse events (TEAEs), respectively.

resultsThe effectiveness and safety analysis set included a total of 521 and 522 patients, respectively. A majority of patients received 10 mg of RAIM (475/522 patients, 91.0%). The mean ± SD total Positive and Negative Syndrome Scale-Excited Component score was 23.6±6.2 (n=318) at baseline (before initial RAIM administration), 17.4±6.8 (n=280) at 2 hours after initial administration, 16.2±6.8 (n=246) 2 days after final administration, 14.9±6.2 (n=248) 3 days after final administration, 13.8±5.9 (n=242) 4 days after final administration, 13.2±5.8 (n=221) 7 days after initial administration, and 13.4±6.2 (n=351) at final observation (with the last observation carried forward approach), showing that reduction in agitation seen with RAIM was sustained with oral dose of olanzapine. The most common TEAEs were dyslalia and somnolence (each event occurred in four patients), and abnormal hepatic function and constipation (occurred in three patients). One serious adverse event of sudden cardiac death occurred after transitioned to oral olanzapine with many other antipsychotic drugs.

conclusionIn the treatment of acute agitation associated with schizophrenia, RAIM could be generally transitioned to oral olanzapine without exacerbating adverse events or losing treatment effect.

Indexed as

agitationJapan postmarketing surveillance studyPANSS-ECrapid-acting intramuscular olanzapineschizophrenia

Identifiers

PMID29719399
PMCPMC5922248

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