Evidence map›Paper›PMID 21950312›Full record

Trial reportBritish journal of clinical pharmacology2012

The safety and tolerability of spironolactone in patients with mild to moderate chronic kidney disease.

Nicola C Edwards, Richard P Steeds, Colin D Chue, Paul M Stewart, Charles J Ferro, Jonathan N Townend

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 5% 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

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

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  16. Management of hyperkalemia during treatment with mineralocorticoid receptor blockers: findings from esaxerenone.Hypertension research : official journal of the Japanese Society of Hypertension · 2021
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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

6 authors at 3 institutions in 2 countries.

Nicola C EdwardsDepartments of Cardiovascular Medicine Cardiology Medicine Nephrology, University Hospital and University of Birmingham, Edgbaston, Birmingham, UK. n.c.edwards@bham.ac.uk
Richard P Steeds
Colin D Chue
Paul M Stewart
Charles J Ferro
Jonathan N Townend
Institute of Cardiology · PLThe Edgbaston Hospital · GBUniversity of Birmingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimMineralocorticoid receptor blockade (MRBs) in combination with angiotensin converting enzyme (ACE) inhibitors and angiotensin-II receptor blockade (ARBs) improve prognostic markers of cardiovascular and renal disease in early stage chronic kidney disease (CKD). Concerns relating to the safety and tolerability of MRBs in CKD may limit their use in a non clinical trial setting. METHODS In the Chronic Renal Impairment in Birmingham II study, 115 patients with non-diabetic early stage CKD (eGFR 30-89ml/min/1.73m(2) ) received 25mg daily of spironolactone for 4 weeks before randomization to continuing treatment or placebo for a further 36 weeks. All patients were on ACE inhibitors and/or ARB therapy. Potassium and renal function were checked at weeks 1, 2, 4, 8, 16, 28 and 40. The incidence of hyperkalaemia, significant renal dysfunction (reduction eGFR ≥25%) and adverse effects was assessed.

resultsAfter 40 weeks of treatment the incidence of serious hyperkalaemia (K(+) ≥6.0mmol/L) was <1%. A potassium 5.5-5.9mmol/L occurred on ≥1 occasion over follow-up in 11 patients (nine on spironolactone) and was predicted by baseline potassium ≥5.0mmol/L and eGFR ≤45 ml/min/1.73m(2) . Over follow-up, three patients experienced significant renal dysfunction but no patients withdrew due to intolerance or side effects. Changes in potassium, eGFR and systolic blood pressure were most apparent in the first 4 eeks.

conclusionSpironolactone was well tolerated in selected patients with early stage CKD. Strict monitoring over the first month of treatment followed by standard surveillance as for ACE inhibitors and ARBs is suggested.

Indexed as

AdultAgedAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersBlood PressureDose-Response Relationship, DrugDrug InteractionsFemaleFollow-Up StudiesGlomerular Filtration RateHumansHyperkalemiaMaleMiddle AgedMineralocorticoid Receptor AntagonistsPotassiumAngiotensin-Converting Enzyme InhibitorsAngiotensin II Type 1 Receptor BlockersMineralocorticoid Receptor AntagonistsPotassiumSpironolactone

Identifiers

PMID21950312
PMCPMC3370349
OpenAlexW1491423257

What OpenQuestion holds

Textmetadata
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.