Evidence map›Paper›PMID 35199478›Full record

Trial reportJournal of diabetes investigation2022

Reduction in the magnitude of serum potassium elevation in combination therapy with esaxerenone (CS-3150) and sodium-glucose cotransporter 2 inhibitor in patients with diabetic kidney disease: Subanalysis of two phase III studies.

Kenichi Shikata, Sadayoshi Ito, Naoki Kashihara, Masaomi Nangaku, Takashi Wada, Yasuyuki Okuda, Tomoko Sawanobori, Kotaro Sugimoto

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 10% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
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  11. Recent progress in the diagnosis and treatment of primary aldosteronism.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
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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

8 authors at 7 institutions in 2 countries.

Kenichi ShikataCenter for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.ORCID https://orcid.org/0000-0003-3598-636X
Sadayoshi ItoDivision of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan.
Naoki KashiharaDepartment of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, Japan.
Masaomi NangakuDivision of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Takashi WadaDepartment of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.
Yasuyuki OkudaData Intelligence Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Tomoko SawanoboriClinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Kotaro SugimotoPrimary Medical Science Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Daiichi-Sankyo (Japan) · JPDaiichi Sankyo (Germany) · DEKanazawa University · JPKawasaki Medical School · JPOkayama University Hospital · JPTohoku University · JPUniversity of Tokyo Hospital · JP

Funding

Daiichi Sankyo Co., Ltd
6 · The paper itself

Abstract

AIMS/

introductionWe evaluated the effect of co-administration of esaxerenone and a sodium-glucose cotransporter 2 (SGLT2) inhibitor on the magnitude of serum potassium elevation in Japanese patients with diabetic kidney disease. MATERIALS AND

methodsWe carried out a prespecified subanalysis of data from two phase III studies: a multicenter, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes and microalbuminuria (J308); and a multicenter, single-arm, open-label trial in patients with type 2 diabetes and macroalbuminuria (J309). Changes in serum potassium levels during the studies and other measures were evaluated according to SGLT2 inhibitor use.

resultsIn both studies, time-course changes in serum potassium levels, and incidence rates of serum potassium elevation were lower in patients with co-administration of SGLT2 inhibitor in both the placebo and esaxerenone groups than those without the inhibitor. In contrast, time-course changes and mean percentage changes from baseline in urinary albumin-to-creatinine ratio, the proportion of patients with albuminuria remission and time-course changes in blood pressure did not change with or without SGLT2 inhibitor, whereas the albumin-to-creatinine ratio and blood pressure were reduced with esaxerenone. The blood glucose-lowering effect of SGLT2 inhibitor was not affected by esaxerenone.

conclusionsIn Japanese patients with type 2 diabetes and albuminuria treated with esaxerenone, concomitant use of SGLT2 inhibitor reduced the magnitude of serum potassium elevation without any change of its antihypertensive and albuminuria-suppressing effects. Co-administration of esaxerenone and SGLT2 inhibitor might be a beneficial treatment option for patients with diabetic kidney disease.

Indexed as

Diabetes Mellitus, Type 2Diabetic NephropathiesSodium-Glucose Transporter 2 InhibitorsAlbuminsAlbuminuriaBlood GlucoseCreatinineHumansPotassiumPyrrolesSodiumSodium-Glucose Transporter 2SulfonesAlbuminsBlood GlucoseCreatinineesaxerenonePotassiumPyrrolesSodiumSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 InhibitorsSulfonesEsaxerenonePotassiumSodium-glucose transporter 2 inhibitor

Identifiers

PMID35199478
PMCPMC9248426
OpenAlexW4213435920

What OpenQuestion holds

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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.