Evidence map›Paper›PMID 39740881›Full record

ReviewIn vivo (Athens, Greece)

Anamorelin and Conduction Defects: A Literature Review and Analysis of the Japanese Pharmacovigilance Database.

Naohiro Yabuki, Ken-Ichi Sako, Tomoji Maeda, Naohito Ide

Abstract readReview
In one paragraph

Review in In vivo (Athens, Greece). 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. Observational
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

4 authors.

Naohiro YabukiDepartment of Pharmacy, Sainokuni Higashiomiya Medical Center, Saitama, Japan.
Ken-Ichi SakoDepartment of Clinical Pharmacology, Nihon Pharmaceutical University, Saitama, Japan.
Tomoji MaedaDepartment of Clinical Pharmacology, Nihon Pharmaceutical University, Saitama, Japan.
Naohito IdeDepartment of Practical Pharmacy, Nihon Pharmaceutical University, Saitama, Japan n-ide@nichiyaku.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimCancer cachexia is characterized by weight loss with a specific decrease in skeletal muscle and adipose tissue. In Japan, anamorelin, which has a novel mechanism of action, was approved in 2021 for the treatment of cancer cachexia. However, little information is available on its safety in routine clinical care, in particular the occurrence of conduction defects as adverse reactions. Therefore, this study evaluated the risk and time to onset of anamorelin-related conduction defects by performing a literature review and evaluating the Japanese pharmacovigilance database. PATIENTS AND

methodsWe reviewed the literature from April 2000 to June 2024 to identify reports of anamorelin-related conduction defects and analyzed data from April 2004 to December 2023 in the Japanese Adverse Drug Event Report (JADER) database. Using the database, we calculated reporting odds ratios (RORs) with 95% confidence intervals (CIs) and adjusted RORs (95%CIs) by considering whether patients were taking concomitant medications that can cause QT prolongation. In addition, we investigated outcomes and time to onset.

resultsThe literature review identified seven cases of conduction defects. All cases occurred within approximately three weeks after starting treatment, and all patients recovered. The JADER database contained 537 cases of adverse reactions to anamorelin. The adjusted ROR (95%CI) of conduction defects was 20.00 (14.86-26.91), and the median time to onset was 13 days. Poor clinical outcomes occurred in only a few cases.

conclusionPerforming frequent cardiac electrograms for two to three weeks after starting anamorelin may help to quickly identify anamorelin-related conduction defects.

Indexed as

Adverse Drug Reaction Reporting SystemsCachexiaHeart Conduction SystemHydrazinesOligopeptidesPharmacovigilanceAgedDatabases, FactualFemaleHumansJapanMaleMiddle AgedNeoplasmsanamorelinHydrazinesOligopeptidesadverse reactionsAnamorelinconduction defectJapanese Adverse Drug Event Report databasereviewtime to onset

Identifiers

PMID39740881
PMCPMC11705112

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Registered trials

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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.