Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy
Aims The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin t...
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| Veröffentlicht in: | European journal of preventive cardiology 2020-04, Vol.27 (6), p.593-603 |
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| container_title | European journal of preventive cardiology |
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| creator | Ballantyne, Christie M Laufs, Ulrich Ray, Kausik K Leiter, Lawrence A Bays, Harold E Goldberg, Anne C Stroes, Erik SG MacDougall, Diane Zhao, Xin Catapano, Alberico L |
| description | Aims
The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin therapy.
Methods
This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or multiple cardiovascular disease risk factors. Patients were randomly assigned (2:2:2:1) to treatment with the fixed-dose combination, bempedoic acid 180 mg, ezetimibe 10 mg or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percentage change from baseline to week 12 in low-density lipoprotein cholesterol.
Results
Among the 301 patients included in the primary analysis, the mean baseline low-density lipoprotein cholesterol level was 3.87 mmol/L (149.8 mg/dL). At week 12, the fixed-dose combination lowered low-density lipoprotein cholesterol (–36.2%) significantly more than placebo (1.8% (placebo-corrected difference –38.0%); P |
| doi_str_mv | 10.1177/2047487319864671 |
| format | Article |
| fullrecord | <record><control><sourceid>sage_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7153222</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_2047487319864671</sage_id><sourcerecordid>10.1177_2047487319864671</sourcerecordid><originalsourceid>FETCH-LOGICAL-c434t-52085ed7e9f09fd2460ff678e65d7d787e30b3192ad4cec38980f6b079849a1c3</originalsourceid><addsrcrecordid>eNp1kU1P3DAQhq2qCBBw51T5D6T4K7FzQWq3fFRC6oX2Gjn2ZGNI4sj2ll1-Cz8Ww7arFglfZuyZ57U9L0KnlHymVMozRoQUSnJaq0pUkn5Ahy9HhVCKftzlkh-gkxjvSF4VYUypfXTAKS-lUvIQPX2FcQbrncHaOIvnYRUxPEJyo2sBd24NtrA-AjZ-bN2kk_MTdhOecwZTivjBpR73mxmC6f0AMUHIYXQa68ni3i17vPj1DQcX73EKoBPYLTPqtRv1MGxwykB4LcSUZSec-ryfN8dor9NDhJM_8Qj9vLy4XVwXNz-uvi--3BRGcJGKkhFVgpVQd6TuLBMV6bpKKqhKK61UEjhp85iYtsKA4apWpKtaImslak0NP0LnW9151Y5gTf5X0EMzh_y-sGm8ds3_lcn1zdL_biQtOWMsC5CtgAk-xgDdjqWkeTGreWtWRj79e-cO-GtNbii2DVEvobnzqzDlGbwv-AwFkqGA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy</title><source>Access via SAGE</source><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Alma/SFX Local Collection</source><creator>Ballantyne, Christie M ; Laufs, Ulrich ; Ray, Kausik K ; Leiter, Lawrence A ; Bays, Harold E ; Goldberg, Anne C ; Stroes, Erik SG ; MacDougall, Diane ; Zhao, Xin ; Catapano, Alberico L</creator><creatorcontrib>Ballantyne, Christie M ; Laufs, Ulrich ; Ray, Kausik K ; Leiter, Lawrence A ; Bays, Harold E ; Goldberg, Anne C ; Stroes, Erik SG ; MacDougall, Diane ; Zhao, Xin ; Catapano, Alberico L</creatorcontrib><description>Aims
The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin therapy.
Methods
This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or multiple cardiovascular disease risk factors. Patients were randomly assigned (2:2:2:1) to treatment with the fixed-dose combination, bempedoic acid 180 mg, ezetimibe 10 mg or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percentage change from baseline to week 12 in low-density lipoprotein cholesterol.
Results
Among the 301 patients included in the primary analysis, the mean baseline low-density lipoprotein cholesterol level was 3.87 mmol/L (149.8 mg/dL). At week 12, the fixed-dose combination lowered low-density lipoprotein cholesterol (–36.2%) significantly more than placebo (1.8% (placebo-corrected difference –38.0%); P < 0.001), ezetimibe alone (–23.2%; P < 0.001) or bempedoic acid alone (–17.2%; P < 0.001). The fixed-dose combination lowered low-density lipoprotein cholesterol levels similarly across subgroups, including patients receiving high-intensity, other-intensity or no statin therapy. Improvements with the fixed-dose combination were also observed in secondary efficacy endpoints, including high-sensitivity C-reactive protein. In this trial, fixed-dose combination treatment had a generally similar safety profile compared with bempedoic acid, ezetimibe or placebo.
Conclusion
The bempedoic acid and ezetimibe fixed-dose combination significantly lowered low-density lipoprotein cholesterol versus placebo or other oral monotherapies and had a favourable safety profile when added to maximally tolerated statin therapy in patients with hypercholesterolemia and high cardiovascular disease risk.
Trial Registration
ClinicalTrials.gov identifier: NCT03337308.</description><identifier>ISSN: 2047-4873</identifier><identifier>EISSN: 2047-4881</identifier><identifier>DOI: 10.1177/2047487319864671</identifier><identifier>PMID: 31357887</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Aged ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - adverse effects ; Biomarkers - blood ; Cardiovascular Diseases - blood ; Cardiovascular Diseases - diagnosis ; Cardiovascular Diseases - prevention & control ; Cholesterol, LDL - blood ; Dicarboxylic Acids - administration & dosage ; Dicarboxylic Acids - adverse effects ; Double-Blind Method ; Down-Regulation ; Drug Combinations ; Drug Treatment ; Ezetimibe - administration & dosage ; Ezetimibe - adverse effects ; Fatty Acids - administration & dosage ; Fatty Acids - adverse effects ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hypercholesterolemia - blood ; Hypercholesterolemia - diagnosis ; Hypercholesterolemia - drug therapy ; Male ; Middle Aged ; Time Factors ; Treatment Outcome ; United States</subject><ispartof>European journal of preventive cardiology, 2020-04, Vol.27 (6), p.593-603</ispartof><rights>The European Society of Cardiology 2019</rights><rights>The European Society of Cardiology 2019 2019 European Society of Cardiology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c434t-52085ed7e9f09fd2460ff678e65d7d787e30b3192ad4cec38980f6b079849a1c3</citedby><cites>FETCH-LOGICAL-c434t-52085ed7e9f09fd2460ff678e65d7d787e30b3192ad4cec38980f6b079849a1c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/2047487319864671$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/2047487319864671$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,21819,27924,27925,43621,43622</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31357887$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ballantyne, Christie M</creatorcontrib><creatorcontrib>Laufs, Ulrich</creatorcontrib><creatorcontrib>Ray, Kausik K</creatorcontrib><creatorcontrib>Leiter, Lawrence A</creatorcontrib><creatorcontrib>Bays, Harold E</creatorcontrib><creatorcontrib>Goldberg, Anne C</creatorcontrib><creatorcontrib>Stroes, Erik SG</creatorcontrib><creatorcontrib>MacDougall, Diane</creatorcontrib><creatorcontrib>Zhao, Xin</creatorcontrib><creatorcontrib>Catapano, Alberico L</creatorcontrib><title>Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy</title><title>European journal of preventive cardiology</title><addtitle>Eur J Cardiovasc Prev Rehabil</addtitle><description>Aims
The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin therapy.
Methods
This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or multiple cardiovascular disease risk factors. Patients were randomly assigned (2:2:2:1) to treatment with the fixed-dose combination, bempedoic acid 180 mg, ezetimibe 10 mg or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percentage change from baseline to week 12 in low-density lipoprotein cholesterol.
Results
Among the 301 patients included in the primary analysis, the mean baseline low-density lipoprotein cholesterol level was 3.87 mmol/L (149.8 mg/dL). At week 12, the fixed-dose combination lowered low-density lipoprotein cholesterol (–36.2%) significantly more than placebo (1.8% (placebo-corrected difference –38.0%); P < 0.001), ezetimibe alone (–23.2%; P < 0.001) or bempedoic acid alone (–17.2%; P < 0.001). The fixed-dose combination lowered low-density lipoprotein cholesterol levels similarly across subgroups, including patients receiving high-intensity, other-intensity or no statin therapy. Improvements with the fixed-dose combination were also observed in secondary efficacy endpoints, including high-sensitivity C-reactive protein. In this trial, fixed-dose combination treatment had a generally similar safety profile compared with bempedoic acid, ezetimibe or placebo.
Conclusion
The bempedoic acid and ezetimibe fixed-dose combination significantly lowered low-density lipoprotein cholesterol versus placebo or other oral monotherapies and had a favourable safety profile when added to maximally tolerated statin therapy in patients with hypercholesterolemia and high cardiovascular disease risk.
Trial Registration
ClinicalTrials.gov identifier: NCT03337308.</description><subject>Aged</subject><subject>Anticholesteremic Agents - administration & dosage</subject><subject>Anticholesteremic Agents - adverse effects</subject><subject>Biomarkers - blood</subject><subject>Cardiovascular Diseases - blood</subject><subject>Cardiovascular Diseases - diagnosis</subject><subject>Cardiovascular Diseases - prevention & control</subject><subject>Cholesterol, LDL - blood</subject><subject>Dicarboxylic Acids - administration & dosage</subject><subject>Dicarboxylic Acids - adverse effects</subject><subject>Double-Blind Method</subject><subject>Down-Regulation</subject><subject>Drug Combinations</subject><subject>Drug Treatment</subject><subject>Ezetimibe - administration & dosage</subject><subject>Ezetimibe - adverse effects</subject><subject>Fatty Acids - administration & dosage</subject><subject>Fatty Acids - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Hypercholesterolemia - blood</subject><subject>Hypercholesterolemia - diagnosis</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>United States</subject><issn>2047-4873</issn><issn>2047-4881</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>EIF</sourceid><recordid>eNp1kU1P3DAQhq2qCBBw51T5D6T4K7FzQWq3fFRC6oX2Gjn2ZGNI4sj2ll1-Cz8Ww7arFglfZuyZ57U9L0KnlHymVMozRoQUSnJaq0pUkn5Ahy9HhVCKftzlkh-gkxjvSF4VYUypfXTAKS-lUvIQPX2FcQbrncHaOIvnYRUxPEJyo2sBd24NtrA-AjZ-bN2kk_MTdhOecwZTivjBpR73mxmC6f0AMUHIYXQa68ni3i17vPj1DQcX73EKoBPYLTPqtRv1MGxwykB4LcSUZSec-ryfN8dor9NDhJM_8Qj9vLy4XVwXNz-uvi--3BRGcJGKkhFVgpVQd6TuLBMV6bpKKqhKK61UEjhp85iYtsKA4apWpKtaImslak0NP0LnW9151Y5gTf5X0EMzh_y-sGm8ds3_lcn1zdL_biQtOWMsC5CtgAk-xgDdjqWkeTGreWtWRj79e-cO-GtNbii2DVEvobnzqzDlGbwv-AwFkqGA</recordid><startdate>20200401</startdate><enddate>20200401</enddate><creator>Ballantyne, Christie M</creator><creator>Laufs, Ulrich</creator><creator>Ray, Kausik K</creator><creator>Leiter, Lawrence A</creator><creator>Bays, Harold E</creator><creator>Goldberg, Anne C</creator><creator>Stroes, Erik SG</creator><creator>MacDougall, Diane</creator><creator>Zhao, Xin</creator><creator>Catapano, Alberico L</creator><general>SAGE Publications</general><scope>AFRWT</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20200401</creationdate><title>Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy</title><author>Ballantyne, Christie M ; Laufs, Ulrich ; Ray, Kausik K ; Leiter, Lawrence A ; Bays, Harold E ; Goldberg, Anne C ; Stroes, Erik SG ; MacDougall, Diane ; Zhao, Xin ; Catapano, Alberico L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c434t-52085ed7e9f09fd2460ff678e65d7d787e30b3192ad4cec38980f6b079849a1c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Anticholesteremic Agents - administration & dosage</topic><topic>Anticholesteremic Agents - adverse effects</topic><topic>Biomarkers - blood</topic><topic>Cardiovascular Diseases - blood</topic><topic>Cardiovascular Diseases - diagnosis</topic><topic>Cardiovascular Diseases - prevention & control</topic><topic>Cholesterol, LDL - blood</topic><topic>Dicarboxylic Acids - administration & dosage</topic><topic>Dicarboxylic Acids - adverse effects</topic><topic>Double-Blind Method</topic><topic>Down-Regulation</topic><topic>Drug Combinations</topic><topic>Drug Treatment</topic><topic>Ezetimibe - administration & dosage</topic><topic>Ezetimibe - adverse effects</topic><topic>Fatty Acids - administration & dosage</topic><topic>Fatty Acids - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Hypercholesterolemia - blood</topic><topic>Hypercholesterolemia - diagnosis</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ballantyne, Christie M</creatorcontrib><creatorcontrib>Laufs, Ulrich</creatorcontrib><creatorcontrib>Ray, Kausik K</creatorcontrib><creatorcontrib>Leiter, Lawrence A</creatorcontrib><creatorcontrib>Bays, Harold E</creatorcontrib><creatorcontrib>Goldberg, Anne C</creatorcontrib><creatorcontrib>Stroes, Erik SG</creatorcontrib><creatorcontrib>MacDougall, Diane</creatorcontrib><creatorcontrib>Zhao, Xin</creatorcontrib><creatorcontrib>Catapano, Alberico L</creatorcontrib><collection>Sage Journals GOLD Open Access 2024</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of preventive cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ballantyne, Christie M</au><au>Laufs, Ulrich</au><au>Ray, Kausik K</au><au>Leiter, Lawrence A</au><au>Bays, Harold E</au><au>Goldberg, Anne C</au><au>Stroes, Erik SG</au><au>MacDougall, Diane</au><au>Zhao, Xin</au><au>Catapano, Alberico L</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy</atitle><jtitle>European journal of preventive cardiology</jtitle><addtitle>Eur J Cardiovasc Prev Rehabil</addtitle><date>2020-04-01</date><risdate>2020</risdate><volume>27</volume><issue>6</issue><spage>593</spage><epage>603</epage><pages>593-603</pages><issn>2047-4873</issn><eissn>2047-4881</eissn><abstract>Aims
The aim of this study was to evaluate the low-density lipoprotein cholesterol lowering efficacy and safety of a bempedoic acid 180 mg and ezetimibe 10 mg fixed-dose combination in patients with hypercholesterolemia and a high risk of cardiovascular disease receiving maximally tolerated statin therapy.
Methods
This phase 3, double-blind clinical trial enrolled adult patients at high risk of cardiovascular disease due to atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or multiple cardiovascular disease risk factors. Patients were randomly assigned (2:2:2:1) to treatment with the fixed-dose combination, bempedoic acid 180 mg, ezetimibe 10 mg or placebo added to stable background statin therapy for 12 weeks. The primary efficacy endpoint was the percentage change from baseline to week 12 in low-density lipoprotein cholesterol.
Results
Among the 301 patients included in the primary analysis, the mean baseline low-density lipoprotein cholesterol level was 3.87 mmol/L (149.8 mg/dL). At week 12, the fixed-dose combination lowered low-density lipoprotein cholesterol (–36.2%) significantly more than placebo (1.8% (placebo-corrected difference –38.0%); P < 0.001), ezetimibe alone (–23.2%; P < 0.001) or bempedoic acid alone (–17.2%; P < 0.001). The fixed-dose combination lowered low-density lipoprotein cholesterol levels similarly across subgroups, including patients receiving high-intensity, other-intensity or no statin therapy. Improvements with the fixed-dose combination were also observed in secondary efficacy endpoints, including high-sensitivity C-reactive protein. In this trial, fixed-dose combination treatment had a generally similar safety profile compared with bempedoic acid, ezetimibe or placebo.
Conclusion
The bempedoic acid and ezetimibe fixed-dose combination significantly lowered low-density lipoprotein cholesterol versus placebo or other oral monotherapies and had a favourable safety profile when added to maximally tolerated statin therapy in patients with hypercholesterolemia and high cardiovascular disease risk.
Trial Registration
ClinicalTrials.gov identifier: NCT03337308.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>31357887</pmid><doi>10.1177/2047487319864671</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| source | Access via SAGE; MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Aged Anticholesteremic Agents - administration & dosage Anticholesteremic Agents - adverse effects Biomarkers - blood Cardiovascular Diseases - blood Cardiovascular Diseases - diagnosis Cardiovascular Diseases - prevention & control Cholesterol, LDL - blood Dicarboxylic Acids - administration & dosage Dicarboxylic Acids - adverse effects Double-Blind Method Down-Regulation Drug Combinations Drug Treatment Ezetimibe - administration & dosage Ezetimibe - adverse effects Fatty Acids - administration & dosage Fatty Acids - adverse effects Female Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Hypercholesterolemia - blood Hypercholesterolemia - diagnosis Hypercholesterolemia - drug therapy Male Middle Aged Time Factors Treatment Outcome United States |
| title | Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy |
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