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Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia
Abstract Aims Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selec...
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| Published in: | European heart journal 2020-10, Vol.41 (40), p.3936-3945 |
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| container_title | European heart journal |
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| creator | Gaudet, Daniel Karwatowska-Prokopczuk, Ewa Baum, Seth J Hurh, Eunju Kingsbury, Joyce Bartlett, Victoria J Figueroa, Amparo L Piscitelli, Philip Singleton, Walter Witztum, Joseph L Geary, Richard S Tsimikas, Sotirios O'Dea, Louis St. L |
| description | Abstract
Aims
Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits angiopoietin-like 3 (ANGPTL3) protein synthesis.
Methods and results
This was a double-blind, placebo-controlled, dose-ranging, Phase 2 study. Patients (N =105) with fasting triglycerides >150 mg/dL (>1.7 mmol/L), type 2 diabetes, and hepatic steatosis were treated for 6 months with 40 or 80 mg every 4 weeks (Q4W), or 20 mg every week (QW) of vupanorsen, or placebo given subcutaneously. The primary efficacy endpoint was per cent change in fasting triglycerides from baseline at 6 months. Median baseline triglycerides were 2.84 mmol/L (252 mg/dL). Significant reductions in triglycerides of 36%, 53%, 47%, and in ANGPTL3 of 41%, 59%, 56%, were observed in the 40 mg Q4W, 80 mg Q4W, and 20 mg QW groups, respectively, compared with 16% reduction in triglycerides and 8% increase in ANGPTL3 in placebo. Compared with placebo, vupanorsen 80 mg Q4W reduced apolipoprotein C-III (58%), remnant cholesterol (38%), total cholesterol (19%), non-high-density lipoprotein cholesterol (HDL-C; 18%), HDL-C (24%), and apolipoprotein B (9%). There was no improvement in glycaemic parameters, or hepatic fat fraction. Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
Conclusion
Vupanorsen results in a favourable lipid/lipoprotein profile and provides a potential strategy for residual cardiovascular risk reduction.
Graphical Abstract
Graphical Abstract |
| doi_str_mv | 10.1093/eurheartj/ehaa689 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7750927</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/eurheartj/ehaa689</oup_id><sourcerecordid>2438679906</sourcerecordid><originalsourceid>FETCH-LOGICAL-c436t-368d3edb935a1867793879f0fb268868f8f5b7b1340c593856d76706549a986b3</originalsourceid><addsrcrecordid>eNqNkkGP0zAUhCMEYsvCD-CCfOSQsE7cOPYFqVrBglQVhBbELXpxXhJXiR1sh1X_Ir8KLy3VcuPkw3wzbyRPkrzM6ZucSnaFixsQXNhf4QDAhXyUrPKyKDLJ1-XjZEVzWWaci-8XyTPv95RSwXP-NLlgheCUsnyV_Pq2zGCs82hSAobsMlAYDiPpYQQVrIdJG8yUNfulh4BthIKOtEfSuqUnwZLN7ubz7ZaR6ctuk5LR3qHzJDjdjweFTrfooykaw4DO9mi0IqOe7exsQG080YbMEDSa4MmdDgNpNTQY0KdkwHtFER8QYhnt0z9Rw2FG9-AC4KThefKkg9Hji9N7mXx9_-72-kO2_XTz8XqzzdSa8ZAxLlqGbSNZCbngVSWZqGRHu6bgQnDRia5sqiZna6rKqJW8rXhFebmWIAVv2GXy9pg7L82ErYq9HYz17PQE7lBb0PW_itFD3dufdVWVVBZVDHh9CnD2x4I-1JP2CscRDNrF18WaxV5SUh7R_IgqZ7132J3P5LS-30B93kB92kD0vHrY7-z4--kRSI-AXeb_yPsNlbHGsg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2438679906</pqid></control><display><type>article</type><title>Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia</title><source>Oxford Journals Online</source><creator>Gaudet, Daniel ; Karwatowska-Prokopczuk, Ewa ; Baum, Seth J ; Hurh, Eunju ; Kingsbury, Joyce ; Bartlett, Victoria J ; Figueroa, Amparo L ; Piscitelli, Philip ; Singleton, Walter ; Witztum, Joseph L ; Geary, Richard S ; Tsimikas, Sotirios ; O'Dea, Louis St. L</creator><creatorcontrib>Gaudet, Daniel ; Karwatowska-Prokopczuk, Ewa ; Baum, Seth J ; Hurh, Eunju ; Kingsbury, Joyce ; Bartlett, Victoria J ; Figueroa, Amparo L ; Piscitelli, Philip ; Singleton, Walter ; Witztum, Joseph L ; Geary, Richard S ; Tsimikas, Sotirios ; O'Dea, Louis St. L ; Vupanorsen Study Investigators ; the Vupanorsen Study Investigators</creatorcontrib><description>Abstract
Aims
Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits angiopoietin-like 3 (ANGPTL3) protein synthesis.
Methods and results
This was a double-blind, placebo-controlled, dose-ranging, Phase 2 study. Patients (N =105) with fasting triglycerides >150 mg/dL (>1.7 mmol/L), type 2 diabetes, and hepatic steatosis were treated for 6 months with 40 or 80 mg every 4 weeks (Q4W), or 20 mg every week (QW) of vupanorsen, or placebo given subcutaneously. The primary efficacy endpoint was per cent change in fasting triglycerides from baseline at 6 months. Median baseline triglycerides were 2.84 mmol/L (252 mg/dL). Significant reductions in triglycerides of 36%, 53%, 47%, and in ANGPTL3 of 41%, 59%, 56%, were observed in the 40 mg Q4W, 80 mg Q4W, and 20 mg QW groups, respectively, compared with 16% reduction in triglycerides and 8% increase in ANGPTL3 in placebo. Compared with placebo, vupanorsen 80 mg Q4W reduced apolipoprotein C-III (58%), remnant cholesterol (38%), total cholesterol (19%), non-high-density lipoprotein cholesterol (HDL-C; 18%), HDL-C (24%), and apolipoprotein B (9%). There was no improvement in glycaemic parameters, or hepatic fat fraction. Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
Conclusion
Vupanorsen results in a favourable lipid/lipoprotein profile and provides a potential strategy for residual cardiovascular risk reduction.
Graphical Abstract
Graphical Abstract</description><identifier>ISSN: 0195-668X</identifier><identifier>EISSN: 1522-9645</identifier><identifier>DOI: 10.1093/eurheartj/ehaa689</identifier><identifier>PMID: 32860031</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Angiopoietin-like Proteins - genetics ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - genetics ; Double-Blind Method ; Fast Track Congress ; Galactosamine ; Humans ; Hypertriglyceridemia - drug therapy ; Hypertriglyceridemia - genetics ; Lipoproteins ; Pharmaceutical Preparations ; RNA, Messenger ; Triglycerides</subject><ispartof>European heart journal, 2020-10, Vol.41 (40), p.3936-3945</ispartof><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology. 2020</rights><rights>The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c436t-368d3edb935a1867793879f0fb268868f8f5b7b1340c593856d76706549a986b3</citedby><cites>FETCH-LOGICAL-c436t-368d3edb935a1867793879f0fb268868f8f5b7b1340c593856d76706549a986b3</cites><orcidid>0000-0002-5185-3666 ; 0000-0001-8189-5093</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,783,787,888,1587,27936,27937</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32860031$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gaudet, Daniel</creatorcontrib><creatorcontrib>Karwatowska-Prokopczuk, Ewa</creatorcontrib><creatorcontrib>Baum, Seth J</creatorcontrib><creatorcontrib>Hurh, Eunju</creatorcontrib><creatorcontrib>Kingsbury, Joyce</creatorcontrib><creatorcontrib>Bartlett, Victoria J</creatorcontrib><creatorcontrib>Figueroa, Amparo L</creatorcontrib><creatorcontrib>Piscitelli, Philip</creatorcontrib><creatorcontrib>Singleton, Walter</creatorcontrib><creatorcontrib>Witztum, Joseph L</creatorcontrib><creatorcontrib>Geary, Richard S</creatorcontrib><creatorcontrib>Tsimikas, Sotirios</creatorcontrib><creatorcontrib>O'Dea, Louis St. L</creatorcontrib><creatorcontrib>Vupanorsen Study Investigators</creatorcontrib><creatorcontrib>the Vupanorsen Study Investigators</creatorcontrib><title>Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia</title><title>European heart journal</title><addtitle>Eur Heart J</addtitle><description>Abstract
Aims
Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits angiopoietin-like 3 (ANGPTL3) protein synthesis.
Methods and results
This was a double-blind, placebo-controlled, dose-ranging, Phase 2 study. Patients (N =105) with fasting triglycerides >150 mg/dL (>1.7 mmol/L), type 2 diabetes, and hepatic steatosis were treated for 6 months with 40 or 80 mg every 4 weeks (Q4W), or 20 mg every week (QW) of vupanorsen, or placebo given subcutaneously. The primary efficacy endpoint was per cent change in fasting triglycerides from baseline at 6 months. Median baseline triglycerides were 2.84 mmol/L (252 mg/dL). Significant reductions in triglycerides of 36%, 53%, 47%, and in ANGPTL3 of 41%, 59%, 56%, were observed in the 40 mg Q4W, 80 mg Q4W, and 20 mg QW groups, respectively, compared with 16% reduction in triglycerides and 8% increase in ANGPTL3 in placebo. Compared with placebo, vupanorsen 80 mg Q4W reduced apolipoprotein C-III (58%), remnant cholesterol (38%), total cholesterol (19%), non-high-density lipoprotein cholesterol (HDL-C; 18%), HDL-C (24%), and apolipoprotein B (9%). There was no improvement in glycaemic parameters, or hepatic fat fraction. Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
Conclusion
Vupanorsen results in a favourable lipid/lipoprotein profile and provides a potential strategy for residual cardiovascular risk reduction.
Graphical Abstract
Graphical Abstract</description><subject>Angiopoietin-like Proteins - genetics</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - genetics</subject><subject>Double-Blind Method</subject><subject>Fast Track Congress</subject><subject>Galactosamine</subject><subject>Humans</subject><subject>Hypertriglyceridemia - drug therapy</subject><subject>Hypertriglyceridemia - genetics</subject><subject>Lipoproteins</subject><subject>Pharmaceutical Preparations</subject><subject>RNA, Messenger</subject><subject>Triglycerides</subject><issn>0195-668X</issn><issn>1522-9645</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNqNkkGP0zAUhCMEYsvCD-CCfOSQsE7cOPYFqVrBglQVhBbELXpxXhJXiR1sh1X_Ir8KLy3VcuPkw3wzbyRPkrzM6ZucSnaFixsQXNhf4QDAhXyUrPKyKDLJ1-XjZEVzWWaci-8XyTPv95RSwXP-NLlgheCUsnyV_Pq2zGCs82hSAobsMlAYDiPpYQQVrIdJG8yUNfulh4BthIKOtEfSuqUnwZLN7ubz7ZaR6ctuk5LR3qHzJDjdjweFTrfooykaw4DO9mi0IqOe7exsQG080YbMEDSa4MmdDgNpNTQY0KdkwHtFER8QYhnt0z9Rw2FG9-AC4KThefKkg9Hji9N7mXx9_-72-kO2_XTz8XqzzdSa8ZAxLlqGbSNZCbngVSWZqGRHu6bgQnDRia5sqiZna6rKqJW8rXhFebmWIAVv2GXy9pg7L82ErYq9HYz17PQE7lBb0PW_itFD3dufdVWVVBZVDHh9CnD2x4I-1JP2CscRDNrF18WaxV5SUh7R_IgqZ7132J3P5LS-30B93kB92kD0vHrY7-z4--kRSI-AXeb_yPsNlbHGsg</recordid><startdate>20201021</startdate><enddate>20201021</enddate><creator>Gaudet, Daniel</creator><creator>Karwatowska-Prokopczuk, Ewa</creator><creator>Baum, Seth J</creator><creator>Hurh, Eunju</creator><creator>Kingsbury, Joyce</creator><creator>Bartlett, Victoria J</creator><creator>Figueroa, Amparo L</creator><creator>Piscitelli, Philip</creator><creator>Singleton, Walter</creator><creator>Witztum, Joseph L</creator><creator>Geary, Richard S</creator><creator>Tsimikas, Sotirios</creator><creator>O'Dea, Louis St. L</creator><general>Oxford University Press</general><scope>TOX</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>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-5185-3666</orcidid><orcidid>https://orcid.org/0000-0001-8189-5093</orcidid></search><sort><creationdate>20201021</creationdate><title>Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia</title><author>Gaudet, Daniel ; Karwatowska-Prokopczuk, Ewa ; Baum, Seth J ; Hurh, Eunju ; Kingsbury, Joyce ; Bartlett, Victoria J ; Figueroa, Amparo L ; Piscitelli, Philip ; Singleton, Walter ; Witztum, Joseph L ; Geary, Richard S ; Tsimikas, Sotirios ; O'Dea, Louis St. L</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c436t-368d3edb935a1867793879f0fb268868f8f5b7b1340c593856d76706549a986b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Angiopoietin-like Proteins - genetics</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - genetics</topic><topic>Double-Blind Method</topic><topic>Fast Track Congress</topic><topic>Galactosamine</topic><topic>Humans</topic><topic>Hypertriglyceridemia - drug therapy</topic><topic>Hypertriglyceridemia - genetics</topic><topic>Lipoproteins</topic><topic>Pharmaceutical Preparations</topic><topic>RNA, Messenger</topic><topic>Triglycerides</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gaudet, Daniel</creatorcontrib><creatorcontrib>Karwatowska-Prokopczuk, Ewa</creatorcontrib><creatorcontrib>Baum, Seth J</creatorcontrib><creatorcontrib>Hurh, Eunju</creatorcontrib><creatorcontrib>Kingsbury, Joyce</creatorcontrib><creatorcontrib>Bartlett, Victoria J</creatorcontrib><creatorcontrib>Figueroa, Amparo L</creatorcontrib><creatorcontrib>Piscitelli, Philip</creatorcontrib><creatorcontrib>Singleton, Walter</creatorcontrib><creatorcontrib>Witztum, Joseph L</creatorcontrib><creatorcontrib>Geary, Richard S</creatorcontrib><creatorcontrib>Tsimikas, Sotirios</creatorcontrib><creatorcontrib>O'Dea, Louis St. L</creatorcontrib><creatorcontrib>Vupanorsen Study Investigators</creatorcontrib><creatorcontrib>the Vupanorsen Study Investigators</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gaudet, Daniel</au><au>Karwatowska-Prokopczuk, Ewa</au><au>Baum, Seth J</au><au>Hurh, Eunju</au><au>Kingsbury, Joyce</au><au>Bartlett, Victoria J</au><au>Figueroa, Amparo L</au><au>Piscitelli, Philip</au><au>Singleton, Walter</au><au>Witztum, Joseph L</au><au>Geary, Richard S</au><au>Tsimikas, Sotirios</au><au>O'Dea, Louis St. L</au><aucorp>Vupanorsen Study Investigators</aucorp><aucorp>the Vupanorsen Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia</atitle><jtitle>European heart journal</jtitle><addtitle>Eur Heart J</addtitle><date>2020-10-21</date><risdate>2020</risdate><volume>41</volume><issue>40</issue><spage>3936</spage><epage>3945</epage><pages>3936-3945</pages><issn>0195-668X</issn><eissn>1522-9645</eissn><abstract>Abstract
Aims
Loss-of-function mutations in ANGPTL3 are associated with beneficial effects on lipid and glucose metabolism and reduced risk of coronary artery disease. Vupanorsen (AKCEA-ANGPTL3-L Rx ) is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits angiopoietin-like 3 (ANGPTL3) protein synthesis.
Methods and results
This was a double-blind, placebo-controlled, dose-ranging, Phase 2 study. Patients (N =105) with fasting triglycerides >150 mg/dL (>1.7 mmol/L), type 2 diabetes, and hepatic steatosis were treated for 6 months with 40 or 80 mg every 4 weeks (Q4W), or 20 mg every week (QW) of vupanorsen, or placebo given subcutaneously. The primary efficacy endpoint was per cent change in fasting triglycerides from baseline at 6 months. Median baseline triglycerides were 2.84 mmol/L (252 mg/dL). Significant reductions in triglycerides of 36%, 53%, 47%, and in ANGPTL3 of 41%, 59%, 56%, were observed in the 40 mg Q4W, 80 mg Q4W, and 20 mg QW groups, respectively, compared with 16% reduction in triglycerides and 8% increase in ANGPTL3 in placebo. Compared with placebo, vupanorsen 80 mg Q4W reduced apolipoprotein C-III (58%), remnant cholesterol (38%), total cholesterol (19%), non-high-density lipoprotein cholesterol (HDL-C; 18%), HDL-C (24%), and apolipoprotein B (9%). There was no improvement in glycaemic parameters, or hepatic fat fraction. Treatment with vupanorsen was not associated with clinically significant changes in platelet counts, and the most common adverse events were those at the injection site, which were generally mild.
Conclusion
Vupanorsen results in a favourable lipid/lipoprotein profile and provides a potential strategy for residual cardiovascular risk reduction.
Graphical Abstract
Graphical Abstract</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>32860031</pmid><doi>10.1093/eurheartj/ehaa689</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-5185-3666</orcidid><orcidid>https://orcid.org/0000-0001-8189-5093</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | European heart journal, 2020-10, Vol.41 (40), p.3936-3945 |
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| source | Oxford Journals Online |
| subjects | Angiopoietin-like Proteins - genetics Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - genetics Double-Blind Method Fast Track Congress Galactosamine Humans Hypertriglyceridemia - drug therapy Hypertriglyceridemia - genetics Lipoproteins Pharmaceutical Preparations RNA, Messenger Triglycerides |
| title | Vupanorsen, an N-acetyl galactosamine-conjugated antisense drug to ANGPTL3 mRNA, lowers triglycerides and atherogenic lipoproteins in patients with diabetes, hepatic steatosis, and hypertriglyceridaemia |
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