Evidence map›Paper›PMID 36159360›Full record

ArticleCureus2022

Current Status of Adverse Event Profile of Cyclosporine in Kidney, Stem Cell, and Heart Transplantations Using the Japanese Pharmacovigilance Database.

Iku Niinomi, Saki Oyama, Ayaka Inada, Tomohito Wakabayashi, Tatsuya Iida, Hiroko Kambara, Mayako Uchida, Yukako Sano, Keiko Hosohata

Abstract read
In one paragraph

Article in Cureus, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

9 authors.

Iku NiinomiEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Saki OyamaEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Ayaka InadaEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Tomohito WakabayashiEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Tatsuya IidaEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Hiroko KambaraEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Mayako UchidaEducation and Research Center for Pharmacy Practice, Doshisha Women's College of Liberal Arts, Kyotanabe-shi, JPN.
Yukako SanoEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.
Keiko HosohataEducation and Research Center for Clinical Pharmacy, Osaka Medical and Pharmaceutical University, Takatsuki, JPN.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCyclosporine is widely used to prevent allograft rejection after transplantation. The purpose of this study was to clarify the adverse events profiles associated with cyclosporine in transplant patients using a spontaneous reporting system database.

methodsRetrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report (JADER) database, with the reporting odds ratio (ROR) and 95% confidence interval (CI) for each adverse event.

resultsThe database comprised 3,327, 958, and 956 reports associated with cyclosporine in the kidney, stem cell, and heart transplant patients, respectively. Infectious and renal disorders were commonly detected in these transplant patients. The signal scores of cyclosporine for toxic nephropathy were noteworthy in the kidney (ROR: 15.1, 95% CI: 11-20.8) and stem cell (ROR, 216; 95% CI, 29.3-1593) transplantation. Cyclosporine in heart transplantation was strongly associated with gastric cancer (ROR, 39.4; 95% CI, 16.7-93.2), but not kidney or stem cell transplantation.

conclusionIt was suggested that there is a diversity in the strength of the association between cyclosporine and adverse events in the kidney, stem cell, and heart transplantation. Our results may provide useful information for treatment with cyclosporine, although further research with more data is needed.

Indexed as

cyclosporinejapanese adverse drug event report (jader) databasereporting odds ratio (ror)spontaneous reporting systemtransplantation

Identifiers

PMID36159360
PMCPMC9490292

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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.