Apolipoprotein C-III reduction in subjects with moderate hypertriglyceridaemia and at high cardiovascular risk
Abstract Aims Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering tr...
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| Published in | European heart journal Vol. 43; no. 14; pp. 1401 - 1412 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Oxford University Press
06.04.2022
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0195-668X 1522-9645 1522-9645 |
| DOI | 10.1093/eurheartj/ehab820 |
Cover
| Abstract | Abstract
Aims
Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease.
Methods and results
A randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 114 patients with fasting serum triglycerides 200–500 mg/dL (2.26–5.65 mmol/L). Patients received olezarsen (10 or 50 mg every 4 weeks, 15 mg every 2 weeks, or 10 mg every week) or saline placebo subcutaneously for 6–12 months. The primary endpoint was the percent change in fasting triglyceride levels from baseline to Month 6 of exposure. Baseline median (interquartile range) fasting triglyceride levels were 262 (222–329) mg/dL [2.96 (2.51–3.71) mmol/L]. Treatment with olezarsen resulted in mean percent triglyceride reductions of 23% with 10 mg every 4 weeks, 56% with 15 mg every 2 weeks, 60% with 10 mg every week, and 60% with 50 mg every 4 weeks, compared with increase by 6% for the pooled placebo group (P-values ranged from 0.0042 to <0.0001 compared with placebo). Significant decreases in apoC-III, very low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were also observed. There were no platelet count, liver, or renal function changes in any of the olezarsen groups. The most common adverse event was mild erythema at the injection site.
Conclusion
Olezarsen significantly reduced apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.
Trial registration number
NCT03385239.
Structured Graphical Abstract
Structured Graphical Abstract
Potential clinical indications for olezarsen. Triglyceride levels represent a continuum of risk with levels 1.7–5.6 mmol/L (150–500 mg/dL) representing primarily cardiovascular disease risk (cardiovascular disease prevention), levels between 5.6 and 10.0 mmol/L (500–885 mg/dL) representing both cardiovascular disease and pancreatitis risk and >10.0 mmol/L primarily pancreatitis risk in patients with familial chylomicronemia syndrome and multifactorial chylomicronemia syndrome (represented by milky plasma). Treatment with olezarsen with the planned Phase 3 doses of 50 and 80 mg subcutaneously monthly would be expected to substantially reduce triglyceride levels in the entire continuum of hypertriglyceridaemia. |
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| AbstractList | Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease.AIMSHypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease.A randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 114 patients with fasting serum triglycerides 200-500 mg/dL (2.26-5.65 mmol/L). Patients received olezarsen (10 or 50 mg every 4 weeks, 15 mg every 2 weeks, or 10 mg every week) or saline placebo subcutaneously for 6-12 months. The primary endpoint was the percent change in fasting triglyceride levels from baseline to Month 6 of exposure. Baseline median (interquartile range) fasting triglyceride levels were 262 (222-329) mg/dL [2.96 (2.51-3.71) mmol/L]. Treatment with olezarsen resulted in mean percent triglyceride reductions of 23% with 10 mg every 4 weeks, 56% with 15 mg every 2 weeks, 60% with 10 mg every week, and 60% with 50 mg every 4 weeks, compared with increase by 6% for the pooled placebo group (P-values ranged from 0.0042 to <0.0001 compared with placebo). Significant decreases in apoC-III, very low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were also observed. There were no platelet count, liver, or renal function changes in any of the olezarsen groups. The most common adverse event was mild erythema at the injection site.METHODS AND RESULTSA randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 114 patients with fasting serum triglycerides 200-500 mg/dL (2.26-5.65 mmol/L). Patients received olezarsen (10 or 50 mg every 4 weeks, 15 mg every 2 weeks, or 10 mg every week) or saline placebo subcutaneously for 6-12 months. The primary endpoint was the percent change in fasting triglyceride levels from baseline to Month 6 of exposure. Baseline median (interquartile range) fasting triglyceride levels were 262 (222-329) mg/dL [2.96 (2.51-3.71) mmol/L]. Treatment with olezarsen resulted in mean percent triglyceride reductions of 23% with 10 mg every 4 weeks, 56% with 15 mg every 2 weeks, 60% with 10 mg every week, and 60% with 50 mg every 4 weeks, compared with increase by 6% for the pooled placebo group (P-values ranged from 0.0042 to <0.0001 compared with placebo). Significant decreases in apoC-III, very low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were also observed. There were no platelet count, liver, or renal function changes in any of the olezarsen groups. The most common adverse event was mild erythema at the injection site.Olezarsen significantly reduced apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.CONCLUSIONOlezarsen significantly reduced apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease.NCT03385239.TRIAL REGISTRATION NUMBERNCT03385239. Structured Graphical Abstract Potential clinical indications for olezarsen. Triglyceride levels represent a continuum of risk with levels 1.7–5.6 mmol/L (150–500 mg/dL) representing primarily cardiovascular disease risk (cardiovascular disease prevention), levels between 5.6 and 10.0 mmol/L (500–885 mg/dL) representing both cardiovascular disease and pancreatitis risk and >10.0 mmol/L primarily pancreatitis risk in patients with familial chylomicronemia syndrome and multifactorial chylomicronemia syndrome (represented by milky plasma). Treatment with olezarsen with the planned Phase 3 doses of 50 and 80 mg subcutaneously monthly would be expected to substantially reduce triglyceride levels in the entire continuum of hypertriglyceridaemia. Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease. A randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 114 patients with fasting serum triglycerides 200-500 mg/dL (2.26-5.65 mmol/L). Patients received olezarsen (10 or 50 mg every 4 weeks, 15 mg every 2 weeks, or 10 mg every week) or saline placebo subcutaneously for 6-12 months. The primary endpoint was the percent change in fasting triglyceride levels from baseline to Month 6 of exposure. Baseline median (interquartile range) fasting triglyceride levels were 262 (222-329) mg/dL [2.96 (2.51-3.71) mmol/L]. Treatment with olezarsen resulted in mean percent triglyceride reductions of 23% with 10 mg every 4 weeks, 56% with 15 mg every 2 weeks, 60% with 10 mg every week, and 60% with 50 mg every 4 weeks, compared with increase by 6% for the pooled placebo group (P-values ranged from 0.0042 to <0.0001 compared with placebo). Significant decreases in apoC-III, very low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were also observed. There were no platelet count, liver, or renal function changes in any of the olezarsen groups. The most common adverse event was mild erythema at the injection site. Olezarsen significantly reduced apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease. NCT03385239. Abstract Aims Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated antisense oligonucleotide targeted to hepatic APOC3 mRNA to inhibit apolipoprotein C-III (apoC-III) production, in lowering triglyceride levels in patients at high risk for or with established cardiovascular disease. Methods and results A randomized, double-blind, placebo-controlled, dose-ranging study was conducted in 114 patients with fasting serum triglycerides 200–500 mg/dL (2.26–5.65 mmol/L). Patients received olezarsen (10 or 50 mg every 4 weeks, 15 mg every 2 weeks, or 10 mg every week) or saline placebo subcutaneously for 6–12 months. The primary endpoint was the percent change in fasting triglyceride levels from baseline to Month 6 of exposure. Baseline median (interquartile range) fasting triglyceride levels were 262 (222–329) mg/dL [2.96 (2.51–3.71) mmol/L]. Treatment with olezarsen resulted in mean percent triglyceride reductions of 23% with 10 mg every 4 weeks, 56% with 15 mg every 2 weeks, 60% with 10 mg every week, and 60% with 50 mg every 4 weeks, compared with increase by 6% for the pooled placebo group (P-values ranged from 0.0042 to <0.0001 compared with placebo). Significant decreases in apoC-III, very low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B were also observed. There were no platelet count, liver, or renal function changes in any of the olezarsen groups. The most common adverse event was mild erythema at the injection site. Conclusion Olezarsen significantly reduced apoC-III, triglycerides, and atherogenic lipoproteins in patients with moderate hypertriglyceridaemia and at high risk for or with established cardiovascular disease. Trial registration number NCT03385239. Structured Graphical Abstract Structured Graphical Abstract Potential clinical indications for olezarsen. Triglyceride levels represent a continuum of risk with levels 1.7–5.6 mmol/L (150–500 mg/dL) representing primarily cardiovascular disease risk (cardiovascular disease prevention), levels between 5.6 and 10.0 mmol/L (500–885 mg/dL) representing both cardiovascular disease and pancreatitis risk and >10.0 mmol/L primarily pancreatitis risk in patients with familial chylomicronemia syndrome and multifactorial chylomicronemia syndrome (represented by milky plasma). Treatment with olezarsen with the planned Phase 3 doses of 50 and 80 mg subcutaneously monthly would be expected to substantially reduce triglyceride levels in the entire continuum of hypertriglyceridaemia. |
| Author | Bartlett, Victoria J Geary, Richard S Tardif, Jean-Claude Amour, Eric St Kingsbury, Joyce Alexander, Veronica J Shapiro, Michael D Baum, Seth J Tami, Joseph Figueroa, Amparo L Tsimikas, Sotirios Ballantyne, Christie M Gaudet, Daniel Moriarty, Patrick M Hurh, Eunju Witztum, Joseph L O’Dea, Louis St L Karwatowska-Prokopczuk, Ewa |
| AuthorAffiliation | 2 Akcea Therapeutics , 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA 9 Division of Endocrinology and Metabolism, University of California, San Diego , 9500 Gilman Drive, BSB1080 La Jolla, CA 92093-0682, USA 5 Wake Forest University School of Medicine, Section on Cardiovascular Medicine 1, Medical Center Boulevard , Winston-Salem, NC 27157, USA 7 Clinical Affiliate Professor of Cardiology, Department of Integrated Medical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, 777 Glades Road, BC-71 Boca Raton, FL 33431, USA 3 Eric St-Amour, MD 214 Cite des jeunes Gatineau , QC J8Y 6S8, Canada 6 Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center , 3901 Rainbow Blvd., Kansas City, KS 66160, USA 1 Jean-Claude Tardif MD Research Center, Montreal Heart Institute , 5000 Belanger Street, Montreal, PQ H1T1C8, Canada 8 Ionis Pharmaceuticals, Inc. , 2855 Gazelle Court, Carlsbad, CA 92010, USA 11 Department of Me |
| AuthorAffiliation_xml | – name: 2 Akcea Therapeutics , 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – name: 11 Department of Medicine, Université de Montréal and Ecogene-21 Clinical Research Centre , Chicoutimi, QC, Canada – name: 10 Division of Cardiovascular Medicine, University of California, San Diego , 9500 Gilman Drive, BSB1080 La Jolla, CA 92093-0682, USA – name: 3 Eric St-Amour, MD 214 Cite des jeunes Gatineau , QC J8Y 6S8, Canada – name: 7 Clinical Affiliate Professor of Cardiology, Department of Integrated Medical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, 777 Glades Road, BC-71 Boca Raton, FL 33431, USA – name: 4 Department of Medicine, Baylor College of Medicine , One Baylor Plaza, MS BCM285, Houston, TX 77030, USA – name: 6 Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center , 3901 Rainbow Blvd., Kansas City, KS 66160, USA – name: 1 Jean-Claude Tardif MD Research Center, Montreal Heart Institute , 5000 Belanger Street, Montreal, PQ H1T1C8, Canada – name: 5 Wake Forest University School of Medicine, Section on Cardiovascular Medicine 1, Medical Center Boulevard , Winston-Salem, NC 27157, USA – name: 9 Division of Endocrinology and Metabolism, University of California, San Diego , 9500 Gilman Drive, BSB1080 La Jolla, CA 92093-0682, USA – name: 8 Ionis Pharmaceuticals, Inc. , 2855 Gazelle Court, Carlsbad, CA 92010, USA |
| Author_xml | – sequence: 1 givenname: Jean-Claude surname: Tardif fullname: Tardif, Jean-Claude email: jean-claude.tardif@icm-mhi.org organization: Jean-Claude Tardif MD Research Center, Montreal Heart Institute, 5000 Belanger Street, Montreal, PQ H1T1C8, Canada – sequence: 2 givenname: Ewa orcidid: 0000-0002-6371-5834 surname: Karwatowska-Prokopczuk fullname: Karwatowska-Prokopczuk, Ewa organization: Akcea Therapeutics, 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – sequence: 3 givenname: Eric St surname: Amour fullname: Amour, Eric St organization: Eric St-Amour, MD 214 Cite des jeunes Gatineau, QC J8Y 6S8, Canada – sequence: 4 givenname: Christie M surname: Ballantyne fullname: Ballantyne, Christie M organization: Department of Medicine, Baylor College of Medicine, One Baylor Plaza, MS BCM285, Houston, TX 77030, USA – sequence: 5 givenname: Michael D orcidid: 0000-0002-9071-3287 surname: Shapiro fullname: Shapiro, Michael D organization: Wake Forest University School of Medicine, Section on Cardiovascular Medicine 1, Medical Center Boulevard, Winston-Salem, NC 27157, USA – sequence: 6 givenname: Patrick M surname: Moriarty fullname: Moriarty, Patrick M organization: Division of Clinical Pharmacology, Department of Internal Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160, USA – sequence: 7 givenname: Seth J orcidid: 0000-0003-1202-8126 surname: Baum fullname: Baum, Seth J organization: Clinical Affiliate Professor of Cardiology, Department of Integrated Medical Science, Charles E. Schmidt College of Medicine, Florida Atlantic University, 777 Glades Road, BC-71 Boca Raton, FL 33431, USA – sequence: 8 givenname: Eunju orcidid: 0000-0001-8189-5093 surname: Hurh fullname: Hurh, Eunju organization: Akcea Therapeutics, 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – sequence: 9 givenname: Victoria J orcidid: 0000-0002-1080-3822 surname: Bartlett fullname: Bartlett, Victoria J organization: Akcea Therapeutics, 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – sequence: 10 givenname: Joyce surname: Kingsbury fullname: Kingsbury, Joyce organization: Akcea Therapeutics, 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – sequence: 11 givenname: Amparo L surname: Figueroa fullname: Figueroa, Amparo L organization: Akcea Therapeutics, 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – sequence: 12 givenname: Veronica J orcidid: 0000-0003-3729-5749 surname: Alexander fullname: Alexander, Veronica J organization: Ionis Pharmaceuticals, Inc., 2855 Gazelle Court, Carlsbad, CA 92010, USA – sequence: 13 givenname: Joseph surname: Tami fullname: Tami, Joseph organization: Ionis Pharmaceuticals, Inc., 2855 Gazelle Court, Carlsbad, CA 92010, USA – sequence: 14 givenname: Joseph L surname: Witztum fullname: Witztum, Joseph L organization: Division of Endocrinology and Metabolism, University of California, San Diego, 9500 Gilman Drive, BSB1080 La Jolla, CA 92093-0682, USA – sequence: 15 givenname: Richard S surname: Geary fullname: Geary, Richard S organization: Ionis Pharmaceuticals, Inc., 2855 Gazelle Court, Carlsbad, CA 92010, USA – sequence: 16 givenname: Louis St L surname: O’Dea fullname: O’Dea, Louis St L organization: Akcea Therapeutics, 55 Cambridge Parkway Suite 100 Cambridge, Boston, MA 02142, USA – sequence: 17 givenname: Sotirios orcidid: 0000-0001-9834-9494 surname: Tsimikas fullname: Tsimikas, Sotirios email: stsimikas@health.ucsd.edu organization: Ionis Pharmaceuticals, Inc., 2855 Gazelle Court, Carlsbad, CA 92010, USA – sequence: 18 givenname: Daniel orcidid: 0000-0002-5185-3666 surname: Gaudet fullname: Gaudet, Daniel organization: Department of Medicine, Université de Montréal and Ecogene-21 Clinical Research Centre, Chicoutimi, QC, Canada |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/35025993$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. 2022 The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. |
| Copyright_xml | – notice: The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. 2022 – notice: The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. |
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| DOI | 10.1093/eurheartj/ehab820 |
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| Keywords | Cardiovascular disease Antisense apoC-III Cardiovascular risk factors Hypertriglyceridaemia Atherosclerosis |
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Aims
Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an... Hypertriglyceridaemia is associated with increased risk of cardiovascular events. This clinical trial evaluated olezarsen, an N-acetyl-galactosamine-conjugated... Structured Graphical Abstract Potential clinical indications for olezarsen. Triglyceride levels represent a continuum of risk with levels 1.7–5.6 mmol/L... |
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| SubjectTerms | Apolipoprotein C-III Cardiovascular Diseases - prevention & control Cholesterol Clinical Research Editor's Choice Heart Disease Risk Factors Humans Hypertriglyceridemia - complications Hypertriglyceridemia - drug therapy Lipoproteins - therapeutic use Risk Factors Triglycerides |
| Title | Apolipoprotein C-III reduction in subjects with moderate hypertriglyceridaemia and at high cardiovascular risk |
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