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A Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial)

Abstract Background A novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms and reduces triglyceride (TG) levels in patients with severe hypertriglyceridemia. Objective This study was designed to evaluate the efficacy of addi... Full description

Journal Title: Clinical therapeutics 2013, Vol.35 (9), p.1400-1411.e3
Main Author: Maki, Kevin C., PhD
Other Authors: Orloff, David G., MD , Nicholls, Stephen J., MBBS, PhD , Dunbar, Richard L., MD , Roth, Eli M., MD, FACC , Curcio, Danielle, MBA , Johnson, Judith, MT , Kling, Douglas, MBA , Davidson, Michael H., MD, FACC
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Bridgewater, NJ: EM Inc USA
ID: ISSN: 0149-2918
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recordid: cdi_gale_infotracacademiconefile_A345856746
title: A Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial)
format: Article
creator:
  • Maki, Kevin C., PhD
  • Orloff, David G., MD
  • Nicholls, Stephen J., MBBS, PhD
  • Dunbar, Richard L., MD
  • Roth, Eli M., MD, FACC
  • Curcio, Danielle, MBA
  • Johnson, Judith, MT
  • Kling, Douglas, MBA
  • Davidson, Michael H., MD, FACC
subjects:
  • Aged
  • Biological and medical sciences
  • Biological Availability
  • Cardiovascular disease
  • Cardiovascular diseases
  • Cardiovascular Diseases - blood
  • Cardiovascular Diseases - prevention & control
  • Cholesterol
  • Cholesterol, HDL - blood
  • Clinical trials
  • Combined Modality Therapy
  • Diet
  • Dietary Supplements
  • Disorders of blood lipids. Hyperlipoproteinemia
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug therapy
  • Drug Therapy, Combination
  • Fatty acids
  • Fatty Acids, Nonesterified - administration & dosage
  • Fatty Acids, Nonesterified - adverse effects
  • Fatty Acids, Nonesterified - therapeutic use
  • Fatty Acids, Omega-3 - administration & dosage
  • Fatty Acids, Omega-3 - adverse effects
  • Fatty Acids, Omega-3 - blood
  • Fatty Acids, Omega-3 - therapeutic use
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
  • Hyperlipidemia
  • hypertriglyceridemia
  • Hypertriglyceridemia - blood
  • Hypertriglyceridemia - complications
  • Hypertriglyceridemia - drug therapy
  • Internal Medicine
  • LDL-C
  • Medical colleges
  • Medical Education
  • Medical sciences
  • Medication Adherence
  • Metabolic diseases
  • Middle Aged
  • Olive Oil
  • omega-3 fatty acids
  • Pharmacology. Drug treatments
  • Plant Oils - administration & dosage
  • Plant Oils - adverse effects
  • Plant Oils - therapeutic use
  • Risk Factors
  • statins
  • Triglycerides
  • Triglycerides - blood
ispartof: Clinical therapeutics, 2013, Vol.35 (9), p.1400-1411.e3
description: Abstract Background A novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms and reduces triglyceride (TG) levels in patients with severe hypertriglyceridemia. Objective This study was designed to evaluate the efficacy of adding OM3-FFA (2 or 4 g/d) to statin therapy for lowering non–HDL-C and TG levels in subjects with persistent hypertriglyceridemia and at high risk for cardiovascular disease. Methods In this double-blind, parallel-group study, 647 diet-stable patients with fasting TG levels ≥200 mg/dL and
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0149-2918
fulltext: fulltext
issn:
  • 0149-2918
  • 1879-114X
url: Link


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titleA Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial)
sourceAlma/SFX Local Collection
creatorMaki, Kevin C., PhD ; Orloff, David G., MD ; Nicholls, Stephen J., MBBS, PhD ; Dunbar, Richard L., MD ; Roth, Eli M., MD, FACC ; Curcio, Danielle, MBA ; Johnson, Judith, MT ; Kling, Douglas, MBA ; Davidson, Michael H., MD, FACC
creatorcontribMaki, Kevin C., PhD ; Orloff, David G., MD ; Nicholls, Stephen J., MBBS, PhD ; Dunbar, Richard L., MD ; Roth, Eli M., MD, FACC ; Curcio, Danielle, MBA ; Johnson, Judith, MT ; Kling, Douglas, MBA ; Davidson, Michael H., MD, FACC
descriptionAbstract Background A novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms and reduces triglyceride (TG) levels in patients with severe hypertriglyceridemia. Objective This study was designed to evaluate the efficacy of adding OM3-FFA (2 or 4 g/d) to statin therapy for lowering non–HDL-C and TG levels in subjects with persistent hypertriglyceridemia and at high risk for cardiovascular disease. Methods In this double-blind, parallel-group study, 647 diet-stable patients with fasting TG levels ≥200 mg/dL and <500 mg/dL (treated with a maximally tolerated dose of statin or statin with ezetimibe) and at high risk for cardiovascular disease were randomized to 6 weeks of treatment with capsules of control (olive oil [OO]) 4 g/d, OM3-FFA 2 g/d (plus 2 g/d OO), or OM3-FFA 4 g/d. Assessments included fasting serum levels of lipids and apolipoproteins (apo); plasma concentrations of eicosapentaenoic acid, docosahexaenoic acid, docosapentaenoic acid, and arachidonic acid; and laboratory safety values and adverse events. Results In the 627 subjects in the intention to treat sample, non–HDL-C levels were reduced with OM3-FFA 2 g/d and OM3-FFA 4 g/d (–3.9% and –6.9%, respectively) compared with OO (–0.9%) (both, P < 0.05), as were TG levels (–14.6% and –20.6%, respectively, vs –5.9%; both, P < 0.001). LDL-C levels increased with OM3-FFA 2 g/d (4.6%) compared with OO (1.1%) ( P = 0.025) but not with OM3-FFA 4 g/d (1.3%). Total cholesterol and VLDL-C concentrations were reduced compared with OO with both OM3-FFA dosages, and the total cholesterol/HDL-C ratio and apo AI and apo B levels were significantly lowered with OM3-FFA 4 g/d only (all at least P < 0.05). Percent changes from baseline in HDL-C did not differ between OO and either OM3-FFA group. Plasma concentrations of docosahexaenoic acid, eicosapentaenoic acid, and docosapentaenoic acid were significantly increased and arachidonic acid was significantly reduced in both OM3-FFA treatment groups compared with the OO responses (all, P < 0.001). Withdrawals related to treatment-emergent adverse events ranged from 0.9% with OO to 3.2% with OM3-FFA 4 g/d. Conclusions OM3-FFA was well tolerated and lowered non–HDL-C and TG levels at both 2- and 4-g/d dosages in patients with persistent hypertriglyceridemia taking a statin, with the 4-g/d dosage providing incremental improvements compared with 2 g/d. ClinicalTrials.gov identifier: NCT01408303.
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1EISSN: 1879-114X
2DOI: 10.1016/j.clinthera.2013.07.420
3PMID: 23998969
languageeng
publisherBridgewater, NJ: EM Inc USA
subjectAged ; Biological and medical sciences ; Biological Availability ; Cardiovascular disease ; Cardiovascular diseases ; Cardiovascular Diseases - blood ; Cardiovascular Diseases - prevention & control ; Cholesterol ; Cholesterol, HDL - blood ; Clinical trials ; Combined Modality Therapy ; Diet ; Dietary Supplements ; Disorders of blood lipids. Hyperlipoproteinemia ; Double-Blind Method ; Drug Administration Schedule ; Drug therapy ; Drug Therapy, Combination ; Fatty acids ; Fatty Acids, Nonesterified - administration & dosage ; Fatty Acids, Nonesterified - adverse effects ; Fatty Acids, Nonesterified - therapeutic use ; Fatty Acids, Omega-3 - administration & dosage ; Fatty Acids, Omega-3 - adverse effects ; Fatty Acids, Omega-3 - blood ; Fatty Acids, Omega-3 - therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hyperlipidemia ; hypertriglyceridemia ; Hypertriglyceridemia - blood ; Hypertriglyceridemia - complications ; Hypertriglyceridemia - drug therapy ; Internal Medicine ; LDL-C ; Medical colleges ; Medical Education ; Medical sciences ; Medication Adherence ; Metabolic diseases ; Middle Aged ; Olive Oil ; omega-3 fatty acids ; Pharmacology. Drug treatments ; Plant Oils - administration & dosage ; Plant Oils - adverse effects ; Plant Oils - therapeutic use ; Risk Factors ; statins ; Triglycerides ; Triglycerides - blood
ispartofClinical therapeutics, 2013, Vol.35 (9), p.1400-1411.e3
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12013 Elsevier HS Journals, Inc.
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32013 Elsevier HS Journals, Inc. All rights reserved.
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5Copyright Elsevier Limited Sep 2013
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0Maki, Kevin C., PhD
1Orloff, David G., MD
2Nicholls, Stephen J., MBBS, PhD
3Dunbar, Richard L., MD
4Roth, Eli M., MD, FACC
5Curcio, Danielle, MBA
6Johnson, Judith, MT
7Kling, Douglas, MBA
8Davidson, Michael H., MD, FACC
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0A Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial)
1Clinical therapeutics
addtitleClin Ther
descriptionAbstract Background A novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms and reduces triglyceride (TG) levels in patients with severe hypertriglyceridemia. Objective This study was designed to evaluate the efficacy of adding OM3-FFA (2 or 4 g/d) to statin therapy for lowering non–HDL-C and TG levels in subjects with persistent hypertriglyceridemia and at high risk for cardiovascular disease. Methods In this double-blind, parallel-group study, 647 diet-stable patients with fasting TG levels ≥200 mg/dL and <500 mg/dL (treated with a maximally tolerated dose of statin or statin with ezetimibe) and at high risk for cardiovascular disease were randomized to 6 weeks of treatment with capsules of control (olive oil [OO]) 4 g/d, OM3-FFA 2 g/d (plus 2 g/d OO), or OM3-FFA 4 g/d. Assessments included fasting serum levels of lipids and apolipoproteins (apo); plasma concentrations of eicosapentaenoic acid, docosahexaenoic acid, docosapentaenoic acid, and arachidonic acid; and laboratory safety values and adverse events. Results In the 627 subjects in the intention to treat sample, non–HDL-C levels were reduced with OM3-FFA 2 g/d and OM3-FFA 4 g/d (–3.9% and –6.9%, respectively) compared with OO (–0.9%) (both, P < 0.05), as were TG levels (–14.6% and –20.6%, respectively, vs –5.9%; both, P < 0.001). LDL-C levels increased with OM3-FFA 2 g/d (4.6%) compared with OO (1.1%) ( P = 0.025) but not with OM3-FFA 4 g/d (1.3%). Total cholesterol and VLDL-C concentrations were reduced compared with OO with both OM3-FFA dosages, and the total cholesterol/HDL-C ratio and apo AI and apo B levels were significantly lowered with OM3-FFA 4 g/d only (all at least P < 0.05). Percent changes from baseline in HDL-C did not differ between OO and either OM3-FFA group. Plasma concentrations of docosahexaenoic acid, eicosapentaenoic acid, and docosapentaenoic acid were significantly increased and arachidonic acid was significantly reduced in both OM3-FFA treatment groups compared with the OO responses (all, P < 0.001). Withdrawals related to treatment-emergent adverse events ranged from 0.9% with OO to 3.2% with OM3-FFA 4 g/d. Conclusions OM3-FFA was well tolerated and lowered non–HDL-C and TG levels at both 2- and 4-g/d dosages in patients with persistent hypertriglyceridemia taking a statin, with the 4-g/d dosage providing incremental improvements compared with 2 g/d. ClinicalTrials.gov identifier: NCT01408303.
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1Biological and medical sciences
2Biological Availability
3Cardiovascular disease
4Cardiovascular diseases
5Cardiovascular Diseases - blood
6Cardiovascular Diseases - prevention & control
7Cholesterol
8Cholesterol, HDL - blood
9Clinical trials
10Combined Modality Therapy
11Diet
12Dietary Supplements
13Disorders of blood lipids. Hyperlipoproteinemia
14Double-Blind Method
15Drug Administration Schedule
16Drug therapy
17Drug Therapy, Combination
18Fatty acids
19Fatty Acids, Nonesterified - administration & dosage
20Fatty Acids, Nonesterified - adverse effects
21Fatty Acids, Nonesterified - therapeutic use
22Fatty Acids, Omega-3 - administration & dosage
23Fatty Acids, Omega-3 - adverse effects
24Fatty Acids, Omega-3 - blood
25Fatty Acids, Omega-3 - therapeutic use
26Humans
27Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage
28Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects
29Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
30Hyperlipidemia
31hypertriglyceridemia
32Hypertriglyceridemia - blood
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34Hypertriglyceridemia - drug therapy
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36LDL-C
37Medical colleges
38Medical Education
39Medical sciences
40Medication Adherence
41Metabolic diseases
42Middle Aged
43Olive Oil
44omega-3 fatty acids
45Pharmacology. Drug treatments
46Plant Oils - administration & dosage
47Plant Oils - adverse effects
48Plant Oils - therapeutic use
49Risk Factors
50statins
51Triglycerides
52Triglycerides - blood
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5Curcio, Danielle, MBA
6Johnson, Judith, MT
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titleA Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial)
authorMaki, Kevin C., PhD ; Orloff, David G., MD ; Nicholls, Stephen J., MBBS, PhD ; Dunbar, Richard L., MD ; Roth, Eli M., MD, FACC ; Curcio, Danielle, MBA ; Johnson, Judith, MT ; Kling, Douglas, MBA ; Davidson, Michael H., MD, FACC
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6Cardiovascular Diseases - prevention & control
7Cholesterol
8Cholesterol, HDL - blood
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10Combined Modality Therapy
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47Plant Oils - adverse effects
48Plant Oils - therapeutic use
49Risk Factors
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51Triglycerides
52Triglycerides - blood
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atitleA Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial)
jtitleClinical therapeutics
addtitleClin Ther
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pages1400-1411.e3
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abstractAbstract Background A novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms and reduces triglyceride (TG) levels in patients with severe hypertriglyceridemia. Objective This study was designed to evaluate the efficacy of adding OM3-FFA (2 or 4 g/d) to statin therapy for lowering non–HDL-C and TG levels in subjects with persistent hypertriglyceridemia and at high risk for cardiovascular disease. Methods In this double-blind, parallel-group study, 647 diet-stable patients with fasting TG levels ≥200 mg/dL and <500 mg/dL (treated with a maximally tolerated dose of statin or statin with ezetimibe) and at high risk for cardiovascular disease were randomized to 6 weeks of treatment with capsules of control (olive oil [OO]) 4 g/d, OM3-FFA 2 g/d (plus 2 g/d OO), or OM3-FFA 4 g/d. Assessments included fasting serum levels of lipids and apolipoproteins (apo); plasma concentrations of eicosapentaenoic acid, docosahexaenoic acid, docosapentaenoic acid, and arachidonic acid; and laboratory safety values and adverse events. Results In the 627 subjects in the intention to treat sample, non–HDL-C levels were reduced with OM3-FFA 2 g/d and OM3-FFA 4 g/d (–3.9% and –6.9%, respectively) compared with OO (–0.9%) (both, P < 0.05), as were TG levels (–14.6% and –20.6%, respectively, vs –5.9%; both, P < 0.001). LDL-C levels increased with OM3-FFA 2 g/d (4.6%) compared with OO (1.1%) ( P = 0.025) but not with OM3-FFA 4 g/d (1.3%). Total cholesterol and VLDL-C concentrations were reduced compared with OO with both OM3-FFA dosages, and the total cholesterol/HDL-C ratio and apo AI and apo B levels were significantly lowered with OM3-FFA 4 g/d only (all at least P < 0.05). Percent changes from baseline in HDL-C did not differ between OO and either OM3-FFA group. Plasma concentrations of docosahexaenoic acid, eicosapentaenoic acid, and docosapentaenoic acid were significantly increased and arachidonic acid was significantly reduced in both OM3-FFA treatment groups compared with the OO responses (all, P < 0.001). Withdrawals related to treatment-emergent adverse events ranged from 0.9% with OO to 3.2% with OM3-FFA 4 g/d. Conclusions OM3-FFA was well tolerated and lowered non–HDL-C and TG levels at both 2- and 4-g/d dosages in patients with persistent hypertriglyceridemia taking a statin, with the 4-g/d dosage providing incremental improvements compared with 2 g/d. ClinicalTrials.gov identifier: NCT01408303.
copBridgewater, NJ
pubEM Inc USA
pmid23998969
doi10.1016/j.clinthera.2013.07.420