Evidence map›Paper›PMID 38622507›Full record

ArticleBMC nephrology2024

Increased risk of hypocalcemia with decreased kidney function in patients prescribed bisphosphonates based on real-world data from the MID-NET

Tomoaki Hasegawa, Maki Komamine, Chieko Ishiguro, Haruka Motomura, Kazuhiro Kajiyama, Takahiro Nonaka, Yuki Nakazato, Ryota Kimura, Harumi Maniwa, Toyotaka Iguchi and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC nephrology, 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
0.3field-weighted citation impact, top 40% 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, 1 citations in OpenAlex.

  1. Review
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

12 authors at 2 institutions in 1 country.

Tomoaki HasegawaOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Maki KomamineOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Chieko IshiguroOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Haruka MotomuraOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Kazuhiro KajiyamaOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Takahiro NonakaOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Yuki NakazatoOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Ryota KimuraOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Harumi ManiwaOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Toyotaka IguchiOffice of Pharmacovigilance II, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Naoya HoriuchiOffice of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yoshiaki UyamaOffice of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-Ku, Tokyo, 100-0013, Japan. uyama-yoshiaki@pmda.go.jp.
Pharmaceuticals and Medical Devices Agency · JPNational Center for Global Health and Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the post-marketing stage, cases of hypocalcemia associated with bisphosphonate preparations (BPs) have been reported in patients with decreased kidney function, despite warning against use of BPs in such patients in the package insert (PI) of Japan. The purpose of this study was to investigate the safety of BPs in patients with decreased kidney function.

methodsThe cohort study was conducted in patients with osteoporosis and newly prescribed bisphosphonate utilizing real-world data from MID-NET

resultsA total of 14,551 patients were included in the analysis, comprising 2,601 (17.88%) with normal (eGFR ≥ 90 mL/min/1.73m

conclusionsThese findings suggest that the risk of hypocalcemia during BP prescription is higher in patients with decreased kidney function, particularly those with severely decreased kidney function. The quantitative real-world evidence on the safety risk of BPs obtained in this study has led to the PI revision describing a relationship between hypocalcemia risk and decreased kidney function as a regulatory action in Japan and will contribute to promoting the proper use of BPs with appropriate risk management in clinical practice.

Indexed as

HypocalcemiaCohort StudiesDiphosphonatesHumansJapanKidneyDiphosphonatesBisphosphonatesHypocalcemiaPharmacoepidemiologyReal-world evidenceRenal impairment

Identifiers

PMID38622507
PMCPMC11017550
OpenAlexW4394819108

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.