Evidence map›Paper›PMID 32358698›Full record

SynthesisDrug safety2020

Effect of Bempedoic Acid on Serum Uric Acid and Related Outcomes: A Systematic Review and Meta-analysis of the available Phase 2 and Phase 3 Clinical Studies.

Arrigo F G Cicero, Roberto Pontremoli, Federica Fogacci, Francesca Viazzi, Claudio Borghi

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
–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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  12. Severe Hypertriglyceridemia After Use of Bempedoic Acid.European journal of case reports in internal medicine · 2023
    Article
  13. 'Use of lipid-lowering therapy: the guidelines, the drugs or the patient?'European heart journal supplements : journal of the European Society of Cardiology · 2022
    Article
  14. Review
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  16. Article
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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

5 authors.

Arrigo F G CiceroDepartment of Medical and Surgical Sciences, Sant'Orsola-Malpighi University Hospital, University of Bologna, Via Albertoni, 15, 40138, Bologna, Italy. arrigo.cicero@unibo.it.
Roberto PontremoliDepartment of Internal Medicine, Università degl Studi and IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Federica FogacciDepartment of Medical and Surgical Sciences, Sant'Orsola-Malpighi University Hospital, University of Bologna, Via Albertoni, 15, 40138, Bologna, Italy.
Francesca ViazziDepartment of Internal Medicine, Università degl Studi and IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Claudio BorghiDepartment of Medical and Surgical Sciences, Sant'Orsola-Malpighi University Hospital, University of Bologna, Via Albertoni, 15, 40138, Bologna, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBempedoic acid (ETC-1002) is a first-in-class lipid-lowering agent recently approved by the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for commercialization.

objectiveThe aim was to assess, through a systematic review of the literature and a meta-analysis of the available phase 2 and phase 3 clinical studies, the effect of treatment with bempedoic acid on serum uric acid (SUA) concentration. Secondary outcomes were treatment-related variations in creatinine serum level and incidence of gout.

methodsA systematic literature search in SCOPUS, PubMed Medline, ISI Web of Science and Google Scholar databases was conducted up to November 13th, 2019, in order to identify clinical trials potentially eligible for the meta-analysis. Effect sizes were expressed as absolute mean differences (MDs) and 95% confidence intervals (CIs).

resultsData were pooled from four clinical studies comprising ten arms, which included overall 3369 subjects, with 2213 in the active-treatment arm and 1156 in the control one. Meta-analysis of data suggested that treatment with bempedoic acid is related to a significant increase in SUA (MD 0.73, 95% CI 0.54-0.91, P < 0.001), serum creatinine (MD 0.04, 95% CI 0.03-0.05, P < 0.001) and the incidence of gout (odds ratio 3.56, 95% CI 1.24-10.19, P = 0.018). The relatively small number of subjects involved in the studies and the exclusion of patients with renal impairment from the clinical trials are important limitations of the meta-analysis. However, our data indicate potential safety issues with bempedoic acid and suggest that further studies are performed both to elucidate the pathogenetic mechanisms underlying these associations and to verify the long-term safety of this treatment.

conclusionBempedoic acid seems to have unfavourable effects on SUA, creatinine level and the incidence of gout. The ongoing Cardiovascular Outcomes Trial (CVOT) will explore the longer-term safety of treatment with bempedoic acid and clarify its effect on cardiovascular events and mortality. PROSPERO DATABASE REGISTRATION: CRD42019146126.

Indexed as

Dicarboxylic AcidsFatty AcidsHypolipidemic AgentsUric AcidClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansTreatment Outcome8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidDicarboxylic AcidsFatty AcidsHypolipidemic AgentsUric Acid

Identifiers

PMID32358698

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.