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 and Claudio Borghi
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Arrigo F. G. Cicero: Sant’Orsola-Malpighi University Hospital, University of Bologna
Roberto Pontremoli: Università degl Studi and IRCCS Ospedale Policlinico San Martino
Federica Fogacci: Sant’Orsola-Malpighi University Hospital, University of Bologna
Francesca Viazzi: Università degl Studi and IRCCS Ospedale Policlinico San Martino
Claudio Borghi: Sant’Orsola-Malpighi University Hospital, University of Bologna

Drug Safety, 2020, vol. 43, issue 8, No 4, 727-736

Abstract: Abstract Introduction Bempedoic 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. Objective The 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. Methods A 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). Results Data 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

Date: 2020
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DOI: 10.1007/s40264-020-00931-6

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