Efficacy and safety of bempedoic acid for the treatment of hypercholesterolemia: A systematic review and meta-analysis
| Title: | Efficacy and safety of bempedoic acid for the treatment of hypercholesterolemia: A systematic review and meta-analysis |
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| Authors: | Cicero A. F. G.; Fogacci F.; Hernandez A. V.; Banach M.; Alnouri F.; Amar F.; Atanasov A. G.; Bajraktari G.; Bartlomiejczyk M. A.; Bjelakovic B.; Bruckert E.; Bielecka-Dabrowa A.; Cafferata A.; Ceska R.; Collet X.; Descamps O.; Devaki N.; Djuric D.; Durst R.; Ezhov M. V.; Fras Z.; Gaita D.; von Haehling S.; Jones S. R.; Jozwiak J.; Kakauridze N.; Katsiki N.; Khera A.; Kostner K.; Kubilius R.; Latkovskis G.; Mancini G. B. J.; Marais A. D.; Martin S. S.; Martinez J. A.; Mazidi M.; Mikhailidis D. P.; Mirrakhimov E.; Miserez A. R.; Mitchenko O.; Moriarty P.; Nabavi S. M.; Panagiotakos D. B.; Paragh G.; Pella D.; Penson P. E.; Petrulioniene Z.; Pirro M.; Postadzhiyan A.; Puri R.; Reda A.; Reiner Z.; Riadh J.; Richter D.; Rizzo M.; Ruscica M.; Sahebkar A.; Sattar N.; Serban M. C.; Shehab A. M. A.; Shek A. B.; Sirtori C. R.; Stefanutti C.; Tomasik T.; Toth P. P.; Viigimaa M.; Vinereanu D.; Vohnout B.; Vrablik M.; Wong N. D.; Yeh H. I.; Zhisheng J.; Zirlik A. |
| Contributors: | Cicero A.F.G.; Fogacci F.; Hernandez A.V.; Banach M.; Alnouri F.; Amar F.; Atanasov A.G.; Bajraktari G.; Bartlomiejczyk M.A.; Bjelakovic B.; Bruckert E.; Bielecka-Dabrowa A.; Cafferata A.; Ceska R.; Collet X.; Descamps O.; Devaki N.; Djuric D.; Durst R.; Ezhov M.V.; Fras Z.; Gaita D.; von Haehling S.; Jones S.R.; Jozwiak J.; Kakauridze N.; Katsiki N.; Khera A.; Kostner K.; Kubilius R.; Latkovskis G.; Mancini G.B.J.; Marais A.D.; Martin S.S.; Martinez J.A.; Mazidi M.; Mikhailidis D.P.; Mirrakhimov E.; Miserez A.R.; Mitchenko O.; Moriarty P.; Nabavi S.M.; Panagiotakos D.B.; Paragh G.; Pella D.; Penson P.E.; Petrulioniene Z.; Pirro M.; Postadzhiyan A.; Puri R.; Reda A.; Reiner Z.; Riadh J.; Richter D.; Rizzo M.; Ruscica M.; Sahebkar A.; Sattar N.; Serban M.C.; Shehab A.M.A.; Shek A.B.; Sirtori C.R.; Stefanutti C.; Tomasik T.; Toth P.P.; Viigimaa M.; Vinereanu D.; Vohnout B.; Vrablik M.; Wong N.D.; Yeh H.I.; Zhisheng J.; Zirlik A. |
| Publisher Information: | Public Library of Science |
| Publication Year: | 2020 |
| Collection: | IRIS Università degli Studi di Palermo |
| Subject Terms: | Anticholesteremic Agents; Apolipoproteins B; Cholesterol; LDL; Clinical Trials; Phase II as Topic; Phase III as Topic; Dicarboxylic Acids; Fatty Acids; Humans; Hypercholesterolemia; Peptide Fragments; Randomized Controlled Trials as Topic |
| Description: | Background Bempedoic acid is a first-in-class lipid-lowering drug recommended by guidelines for the treatment of hypercholesterolemia. Our objective was to estimate its average effect on plasma lipids in humans and its safety profile. Methods and findings We carried out a systematic review and meta-analysis of phase II and III randomized controlled trials on bempedoic acid (PROSPERO: CRD42019129687). PubMed (Medline), Scopus, Google Scholar, and Web of Science databases were searched, with no language restriction, from inception to 5 August 2019. We included 10 RCTs (n = 3,788) comprising 26 arms (active arm [n = 2,460]; control arm [n = 1,328]). Effect sizes for changes in lipids and high-sensitivity C-reactive protein (hsCRP) serum concentration were expressed as mean differences (MDs) and 95% confidence intervals (CIs). For safety analyses, odds ratios (ORs) and 95% CIs were calculated using the Mantel–Haenszel method. Bempedoic acid significantly reduced total cholesterol (MD −14.94%; 95% CI −17.31%, −12.57%; p < 0.001), non-high-density lipoprotein cholesterol (MD −18.17%; 95% CI −21.14%, −15.19%; p < 0.001), low-density lipoprotein cholesterol (MD −22.94%; 95% CI −26.63%, −19.25%; p < 0.001), low-density lipoprotein particle number (MD −20.67%; 95% CI −23.84%, −17.48%; p < 0.001), apolipoprotein B (MD −15.18%; 95% CI −17.41%, −12.95%; p < 0.001), high-density lipoprotein cholesterol (MD −5.83%; 95% CI −6.14%, −5.52%; p < 0.001), high-density lipoprotein particle number (MD −3.21%; 95% CI −6.40%, −0.02%; p = 0.049), and hsCRP (MD −27.03%; 95% CI −31.42%, −22.64%; p < 0.001). Bempedoic acid did not significantly modify triglyceride level (MD −1.51%; 95% CI −3.75%, 0.74%; p = 0.189), verylow-density lipoprotein particle number (MD 3.79%; 95% CI −9.81%, 17.39%; p = 0.585), and apolipoprotein A-1 (MD −1.83%; 95% CI −5.23%, 1.56%; p = 0.290). Treatment with bempedoic acid was positively associated with an increased risk of discontinuation of treatment (OR 1.37; 95% CI 1.06, 1.76; p = 0.015), ... |
| Document Type: | article in journal/newspaper |
| Language: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/32673317; info:eu-repo/semantics/altIdentifier/wos/WOS:000553974800004; volume:17; issue:7; numberofpages:21; journal:PLOS MEDICINE; https://hdl.handle.net/10447/549427 |
| DOI: | 10.1371/journal.pmed.1003121 |
| Availability: | https://hdl.handle.net/10447/549427; https://doi.org/10.1371/journal.pmed.1003121 |
| Rights: | info:eu-repo/semantics/openAccess |
| Accession Number: | edsbas.AF46EDCE |
| Database: | BASE |