Evidence map›Paper›PMID 39553150›Full record

ArticleCureus2024

Comparison of Adverse Event Profiles of Amphotericin B Formulations Using Real-World Data.

Yuka Nokura, Mika Maezawa, Koumi Miyasaka, Sakiko Hirofuji, Satoshi Nakao, Moe Yamashita, Nanaka Ichihara, Kana Sugishita, Tomofumi Yamazaki, Hirofumi Tamaki and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cureus, 2024. 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
–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

1 citing paper in PubMed.

  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

13 authors.

Yuka NokuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Mika MaezawaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Koumi MiyasakaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Sakiko HirofujiLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Satoshi NakaoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Moe YamashitaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Nanaka IchiharaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Kana SugishitaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Tomofumi YamazakiLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Hirofumi TamakiLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, JPN.
Kazuhiro IguchiLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, JPN.
Kohei TaharaLaboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, Gifu, JPN.
Mitsuhiro NakamuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Amphotericin B deoxycholate (AMPH-B) is a polyene macrolide with antifungal activity. Liposomal AMPH-B (L-AMB) was developed to reduce side effects while maintaining antifungal activity. This study was aimed at evaluating and comparing the adverse event profiles of AMPH-B and L-AMB using a spontaneous reporting system. We analyzed the adverse event reports of AMPH-B and L-AMB from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Case report counts of adverse events were generated according to the preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA). Standardized MedDRA queries (SMQs) and system organ classes (SOCs) were used to compare the organ-specific adverse event profiles of AMPH-B and L-AMB. The reporting odds ratio and proportional reporting rate were used to detect pharmacovigilance signals. The FAERS database contains 21,173,818 cases from January 2004 to March 2024. Adverse events were reported in 2438 cases receiving AMPH-B treatment and 3344 cases receiving L-AMB treatment, including 848 and 1591 cases receiving intravenous AMPH-B and L-AMB injections, respectively. The most frequently reported drug-related adverse event in the AMPH-B and L-AMB groups was hypokalemia. SOCs with statistically significant differences were "Inv" (laboratory tests), "Resp" (respiratory, thoracic, and mediastinal disorders), "Genrl" (general and systemic disorders and conditions at the site of administration), "Card" (cardiac disorders), and "Blood" (blood and lymphatic system disorders). No statistically significant difference was observed in the SMQ profile of adverse events in "Renal" (renal and urinary disorders) and "Hepat" (hepatobiliary disorders) between the L-AMB and AMPH-B formulations in this study. Based on real-world data from FAERS, adverse event profiles of AMPH-B and L-AMB were compared. No statistically significant difference was observed in the SMQ profile of adverse events in the renal and hepatic SOCs between the L-AMB and AMPH-B formulations. Our results suggest that L-AMB is more tolerated by the kidneys than AMPH-B.

Indexed as

ambisomeamphotericin bfda adverse event reporting systemfungizoneliposomal amphotericin b

Identifiers

PMID39553150
PMCPMC11565214

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.