- 1.
Clinical Study Report: AMR-01-01-0019. Title of report [CONFIDENTIAL internal manufacturer’s report]. City (PROV): Manufacturer; 2019.
- 2.
Clinical Study Report: AMR-01-01-0017. Title of report [CONFIDENTIAL internal manufacturer’s report]. City (PROV): Manufacturer; 2011.
- 3.
Laslett
LJ, Alagona
P, Jr., Clark
BA, 3rd, et al. The worldwide environment of cardiovascular disease: prevalence, diagnosis, therapy, and policy issues: a report from the American College of Cardiology.
J Am Coll Cardiol. 2012;60:(25 Suppl):S1–49. [
PubMed: 23257320]
- 4.
- 5.
Ginsberg
HN. Hypertriglyceridemia: new insights and new approaches to pharmacologic therapy. Am J Cardiol. 2001;87(10):1174–1180; A1174.
- 6.
Assmann
G, Schulte
H, von Eckardstein
A. Hypertriglyceridemia and elevated lipoprotein(a) are risk factors for major coronary events in middle-aged men. Am J Cardiol. 1996;77(14):1179–1184.
- 7.
Cholesterol Treatment Trialists Collaboration, Baigent
C, Blackwell
L, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670–1681.
- 8.
Freiberg
JJ, Tybjaerg-Hansen
A, Jensen
JS, Nordestgaard
BG. Nonfasting triglycerides and risk of ischemic stroke in the general population. JAMA. 2008;300(18):2142–2152.
- 9.
Rosenson
RS, Kastelein
JJP. Hypertriglyceridemia. In: Post
TW, ed.
UpToDate. Waltham (MA): UptoDate; 2019:
www.uptodate.com/. Accessed 2019 Aug 13.
- 10.
- 11.
Anderson
TJ, Gregoire
J, Pearson
GJ, et al. 2016 Canadian Cardiovascular Society guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult.
Can J Cardiol. 2016;32(11):1263–1282. [
PubMed: 27712954]
- 12.
Chou
R, Dana
T, Blazina
I, Daeges
M, Jeanne
TL. Statins for Prevention of Cardiovascular Disease in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force.
JAMA. 2016;316(19):2008–2024. [
PubMed: 27838722]
- 13.
de Vries
FM, Denig
P, Pouwels
KB, Postma
MJ, Hak
E. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis.
Drugs. 2012;72(18):2365–2373. [
PubMed: 23186103]
- 14.
Grundy
SM, Stone
NJ, Bailey
AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
Circulation. 2019;139(25):e1082–e1143. [
PMC free article: PMC7403606] [
PubMed: 30586774]
- 15.
Kromhout
D, Bosschieter
EB, de Lezenne Coulander
C. The inverse relation between fish consumption and 20-year mortality from coronary heart disease.
N Engl J Med. 1985;312(19):1205–1209. [
PubMed: 3990713]
- 16.
Zheng
J, Huang
T, Yu
Y, Hu
X, Yang
B, Li
D. Fish consumption and CHD mortality: an updated meta-analysis of seventeen cohort studies.
Public Health Nutr. 2012;15(4):725–737. [
PubMed: 21914258]
- 17.
Aung
T, Halsey
J, Kromhout
D, et al. Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77917 Individuals.
JAMA Cardiol. 2018;3(3):225–234. [
PMC free article: PMC5885893] [
PubMed: 29387889]
- 18.
Sherratt
SCR, Mason
RP. Eicosapentaenoic acid and docosahexaenoic acid have distinct membrane locations and lipid interactions as determined by X-ray diffraction.
Chem Phys Lipids. 2018;212:73–79. [
PubMed: 29355517]
- 19.
Yokoyama
M, Origasa
H, Matsuzaki
M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis.
Lancet. 2007;369(9567):1090–1098. [
PubMed: 17398308]
- 20.
Vascepa (icosapent ethyl): capsules, 0.5 g or 1 g, for oral use [product monograph]. Product Monograph: Vascepa. Etobicoke (ON): HLS Therapeutics Inc.; 2019.
- 21.
Ezetimibe [product monograph]. Saint-Laurent (QC): Sivem Pharmaceuticals ULC; 2017
Jan
17.
- 22.
Fenofibrate Sandoz (fenofibrate) film-coated tablets 100 mg, 160 mg and 200 mg, for oral use [product monograph]. Boucherville (QC): Sandoz Canada, Inc.; 2009
Oct
27.
- 23.
Fish oil (natural health product): capsules with 100 to 5,000 mg of EPA and/or DHA for oral use [product monograph]. Ottawa (ON): Health Canada; 2018
Sep
25.
- 24.
Niaspan FCT (extended-release niacin): extended-release film coated tablets, 500 mg and 1 g, for oral use [product monograph]. Mississauga, (ON): Sunovion Pharmaceuticals Canada Inc.; 2017
Oct
18.
- 25.
Bhatt
DL, Steg
PG, Miller
M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia.
N Engl J Med. 2019;380(1):11–22. [
PubMed: 30415628]
- 26.
Ballantyne
CM, Bays
HE, Kastelein
JJ, et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study).
Am J Cardiol. 2012;110(7):984–992. [
PubMed: 22819432]
- 27.
Bays
HE, Ballantyne
CM, Braeckman
RA, Stirtan
WG, Soni
PN. Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies.
Am J Cardiovasc Drugs. 2013;13(1):37–46. [
PMC free article: PMC3572383] [
PubMed: 23325450]
- 28.
Ballantyne
CM, Braeckman
RA, Bays
HE, et al. Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study).
J Clin Lipidol. 2015;9(3):377–383. [
PubMed: 26073397]
- 29.
Stone
NJ, Robinson
JG, Lichtenstein
AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.
J Am Coll Cardiol. 2014;63(25 Pt B):2889–2934. [
PubMed: 24239923]
- 30.
Ganda
OP, Bhatt
DL, Mason
RP, Miller
M, Boden
WE. Unmet Need for Adjunctive Dyslipidemia Therapy in Hypertriglyceridemia Management.
J Am Coll Cardiol. 2018;72(3):330–343. [
PubMed: 29935936]
- 31.
Origin Trial Investigators, Bosch
J, Gerstein
HC, et al. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia.
N Engl J Med. 2012;367(4):309–318. [
PubMed: 22686415]
- 32.
Ascend Study Collaborative Group, Bowman
L, Mafham
M, et al. Effects of n-3 fatty acid supplements in diabetes mellitus.
N Engl J Med. 2018;379(16):1540–1550. [
PubMed: 30146932]
- 33.
Maki
KC, Bobotas
G, Dicklin
MR, Huebner
M, Keane
WF. Effects of MAT9001 containing eicosapentaenoic acid and docosapentaenoic acid, compared to eicosapentaenoic acid ethyl esters, on triglycerides, lipoprotein cholesterol, and related variables.
J Clin Lipidol. 2017;11(1):102–109. [
PubMed: 28391875]
- 34.
Bhatt
DL, Steg
PG, Miller
M, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT.
J Am Coll Cardiol. 2019;73(22):2791–2802. [
PubMed: 30898607]
- 35.
Bays
HE, Ballantyne
CM, Kastelein
JJ, Isaacsohn
JL, Braeckman
RA, Soni
PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial).
Am J Cardiol. 2011;108(5):682–690. [
PubMed: 21683321]
- 36.
Mosca
L, Ballantyne
CM, Bays
HE, et al. Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials).
Am J Cardiol. 2017;119(3):397–403. [
PubMed: 27939227]
- 37.
Budoff
M, Brent Muhlestein
J, Le
VT, May
HT, Roy
S, Nelson
JR. Effect of Vascepa (icosapent ethyl) on progression of coronary atherosclerosis in patients with elevated triglycerides (200-499 mg/dL) on statin therapy: Rationale and design of the EVAPORATE study.
Clin Cardiol. 2018;41(1):13–19. [
PMC free article: PMC5838559] [
PubMed: 29365351]
- 38.
Bays
HE, Braeckman
RA, Ballantyne
CM, et al. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study).
J Clin Lipidol. 2012;6(6):565–572. [
PubMed: 23312052]
- 39.
Bhatt
DL, Steg
PG, Brinton
EA, et al. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial.
Clin Cardiol. 2017;40(3):138–148. [
PMC free article: PMC5396348] [
PubMed: 28294373]