| EXAMINATION | - Deepak L Bhatt, "Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia", doi:10.1056/NEJMoa1812792, (20190103), URL: https://www.nejm.org/doi/pdf/10.1056/NEJMoa1812792?articleTools=true, (20200303), XP055673350 | |
| OPPOSITION | - Amarin Pharma Inc., "Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (ANCHOR) - NCT01047501", Clinical Trials, clinicaltrials.gov, (20110721), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01047501?term=NCT01047501&rank=1&a=5, XP093279133 | - |
| OPPOSITION | - Anonymous, "Amarin's AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4 Gram and 2 Gram Doses and Statistically Significant Decrease in LDL-C", AMARIN, (20110408), pages 1 - 3, XP055843598 | - |
| OPPOSITION | - Anonymous, "AMARIN'S AMR101 PHASE 3 ANCHOR TRIAL MEETS ALL PRIMARY AND SECONDARY ENDPOINTS WITH STATISTICALLY SIGNIFICANT REDUCTIONS IN TRIGLYCERIDES AT BOTH 4 GRAM AND 2 GRAM DOSES AND STATISTICALLY SIGNIFICANT DECREASE IN LDL-C", AMARIN, (20120418), pages 1 - 3, AMARIN, (20210927), XP055844794 | - |
| OPPOSITION | - Anonymous, "Epadel Capsules 300 (English translation of Japanese drug information brochure)", Mochida Pharmaceutical Co., Ltd., (20000101), pages 1 - 20, XP055260418 | - |
| OPPOSITION | - Anonymous, "FDA Briefing Document - Endocrinologic and Metabolic Drugs Advisory Committee Meeting", FDA, (20131016), FDA, URL: https://scispace.com/pdf/the-evidence-for-fish-oils-and-eicosapentaenoic-acid-in-kruu8m93.pdf, XP093279137 | - |
| OPPOSITION | - Anonymous, "Federal Register extract", FDA, (20040115), vol. 69, no. 10, pages 2313 - 2317, XP093279139 | - |
| OPPOSITION | - Anonymous, " Glossary of Common Site Terms", ClinicalTrials.gov, (20210506), pages 1 - 19, XP055954792 | - |
| OPPOSITION | - Anonymous, "High Blood Cholesterol What you need to know", US Department of Health and Human Services, (20050101), pages 1 - 6, XP093258740 | - |
| OPPOSITION | - Anonymous, "History of Changes for Study: NCT01492361 A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)", ClinicalTrials.gov archive, (20120316), pages 1 - 17, XP055844076 | - |
| OPPOSITION | - Anonymous, "Overview Coronary angioplasty and stent insertion", NHS, (20221004), NHS, URL: https://www.nhs.uk/conditions/coronary-angioplasty/#:~:text=The%20term%20%22angioplasty%22%20means%20using,blood%20to%20flow%20more%20freely., (20231219), XP093113571 | - |
| OPPOSITION | - Anonymous, "Trilipix Fenofibric Acid Delayed Release Capsules", FDA, (20181101), pages 1 - 59, FDA, (20231219), XP093113578 | - |
| OPPOSITION | - BALLANTYNE CHRISTIE M ET AL, "AMR101 Lowers Triglycerides, Atherogenic Lipoprotein, Phospholipase A(2), and High-sensitivity C-reactive Protein Levels in Patients With High Triglycerides and on Background Statin Therapy (the ANCHOR Study)", CIRCULATION, & SCIENTIFIC SESSIONS OF THE AMERICAN-HEART-ASSOCIATION/RESUSCITATION SCIENCE SYMPOSIUM; ORLANDO, FL, USA; NOVEMBER 12 -16, 2011, & SCIENTIFIC SESSIONS OF THE AMERICAN-HEART-ASSOCIATION/RESUSCITATION SCIENCE SYMPOSIUM; ORLANDO, FL, USA; NOVEMBER 12 -16, 2011 , (20111101), vol. 124, no. 21, Suppl. S, page A15071, XP002752591 | - |
| OPPOSITION | - "Cardiovascular Disease", Loyd V. Allen, Jr, Remington: The Science and Practice of Pharmacy 22nd Edition, Pharmaceutical Press , (20130101), pages 2595 - 2599, ISBN 978-0-85711-062-6, XP009561564 | - |
| OPPOSITION | - D24 - T 239/16 | - |
| OPPOSITION | - D8a - Supplementary Appendix | - |
| OPPOSITION | - Glaxosmithkline, "LOVAZA HIGHLIGHTS OF PRESCRIBING INFORMATION", (20140501), URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf, (20190925), XP055625991 | - |
| OPPOSITION | - Iggy Igette, "Amarin's Fish Oil: Blazing a New Path against Cardiovascular Disease", Seeking Alpha, (20120502), pages 1 - 23, Seeking Alpha, URL: https://seekingalpha.com/article/552781-ama rins-fish-oi l-blazi ng-a-new-path-aga inst- cardiovascular-disease, (20210927), XP055844745 | - |
| OPPOSITION | - Panikar V., "Mixed Dyslipidemia", Medicine Update, (20080101), vol. 18, no. 101, pages 1 - 6, XP055843594 | - |
| OPPOSITION | - Trevor A Mori et al, "Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men", AM J Clinical Nutr, (2000), vol. 71, XP002410552 | - |
| OPPOSITION | - N Nakaruma, et al, "Joint effects of HMG-CoA reductase inhibitors and eicosapentaenoic acids on serum lipid profile and plasma fatty acid concentrations in patients with hyperlipidemia", International Journal of Clinical and Laboratory Research , (1999), vol. 29, doi:10.1007/s005990050057, XP002558875 | |
| OPPOSITION | - Beatriz G Talayero et al, "The Role of Triglycerides in Atherosclerosis", Curr Cardiol Rep, (2011), vol. 13, doi:10.1007/s11886-011-0220-3, XP019972113 | |
| OPPOSITION | - Harold E. Bays; Christie M. Ballantyne; John J. Kastelein; Jonathan L. Isaacsohn; Rene A. Braeckman; Paresh N. Soni;, "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)", AMERICAN JOURNAL OF CARDIOLOGY., CAHNERS PUBLISHING CO., NEWTON, MA,, US, US , (20110424), vol. 108, no. 5, doi:10.1016/j.amjcard.2011.04.015, ISSN 0002-9149, pages 682 - 690, XP028262633 | |
| OPPOSITION | - for the COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators Davidson, M.H. Stein, E.A. Bays, H.E. Maki, K.C. Doyle, R.T. Shalwitz, R.A. Ballantyne, C.M. Ginsberg, H.N., "Efficacy and tolerability of adding prescription Omega-3 fatty acids 4 g/d to Simvastatin 40 mg/d in hypertriglyceridemic patients: An 8-week, randomized, double-blind, placebo-controlled study", Clinical Therapeutics, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20070815), vol. 29, no. 7, doi:10.1016/j.clinthera.2007.07.018, ISSN 0149-2918, pages 1354 - 1367, XP022230024 | |
| OPPOSITION | - Erin D. Michos; Christopher T. Sibley; Jefferson T. Baer; Michael J. Blaha; Roger S. Blumenthal;, "Niacin and Statin Combination Therapy for Atherosclerosis Regression and Prevention of Cardiovascular Disease Events", Journal of the American College of Cardiology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20120125), vol. 59, no. 23, doi:10.1016/j.jacc.2012.01.045, ISSN 0735-1097, pages 2058 - 2064, XP028510520 | |
| OPPOSITION | - Mitsuhiro Yokoyama, Hideki Origasa, Masunori Matsuzaki, Yuji Matsuzawa, Yasushi Saito, Yuichi Ishikawa, Shinichi Oikawa, Jun Sasaki, Hitoshi Hishida, Hiroshige Itakura, Toru Kita, Akira Kitabatake, Noriaki Nakaya, Toshiie Sakata, Kazuyuki Shimada, Kunio Shirato, "Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20070331), vol. 369, no. 9567, doi:10.1016/S0140-6736(07)60527-3, pages 1090 - 1098, XP002633503 | |
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| OPPOSITION | - MARCHIOLI R., ET AL., "DIETARY SUPPLEMENTATION WITH N-3 POLYUNSTURATED FATTY ACIDS AND VITAMIN E AFTER MYOCARDIAL INFARCTION: RESULTS OF THE GISSI-PREVENZIONE TRIAL", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (19990807), vol. 354, no. 9177, doi:10.1016/S0140-6736(99)07072-5, pages 447 - 455, XP002508721 | |
| OPPOSITION | - NORDOY A,ET AL, "Effects of Simvastatin and omega-3 fatty acids on plasma lipoproteins and lipid peroxidation in patients with combined hyperlipidaemia", JOURNAL OF INTERNAL MEDICINE, Blackwell Publishing Ltd, GB, GB , (19980201), vol. 243, no. 2, doi:10.1046/j.1365-2796.1998.00297.x, ISSN 0954-6820, pages 163 - 170, XP002371430 | |
| OPPOSITION | - Anonymous, "COMPARISON OF CORONARY BYPASS SURGERY WITH ANGIOPLASTY IN PATIENTS WITH MULTIVESSEL DISEASE", The New England Journal of Medicine, Elsevier Ltd, (19960725), vol. 336, no. 4, doi:10..1056/NEJM199607253350401, pages 217 - 225, XP093113566 | |
| OPPOSITION | - CANNON C P, ET AL., "INTENSIVE VERSUS MODERATE LIPID LOWERING WITH STATINS AFTER ACUTE CORONARY SYNDROMES", New England Journal of Medicine, The - NEJM, Massachusetts Medical Society, US, US , (20040408), vol. 350, no. 15, doi:10.1056/NEJMoa040583, ISSN 1533-4406, pages 1495 - 1504, XP009065992 | |
| OPPOSITION | - Deepak L Bhatt, "Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia", doi:10.1056/NEJMoa1812792, (20190103), URL: https://www.nejm.org/doi/pdf/10.1056/NEJMoa1812792?articleTools=true, (20200303), XP055673350 | |
| OPPOSITION | - J. Perk, G. De Backer, H. Gohlke, I. Graham, Z. Reiner, M. Verschuren, C. Albus, P. Benlian, G. Boysen, R. Cifkova, C. Deaton, S. Ebrahim, M. Fisher, G. Germano, R. Hobbs, A. Hoes, S. Karadeniz, A. Mezzani, E. Prescott, L. Ryden, M. Scherer, M. Syvanne, W. J. M. Scholte Op Reimer, C. Vrints, D. Wood, J. L. Zamorano, F. Zannad, M. T. Cooney, J. Bax, H. Baumgartner, C. Ceconi, V. Dean, R. Fagard, C. Funck-Brentano, D. Hasdai, P. Kirchhof, J. Knuuti, P. Kolh, T. Mcdonagh, C. Moulin, B. A. Popescu, U. Sechtem, P. A. Sirnes, M. Tendera, A. Torbicki, A. Vahanian, S. Windecker, V. Aboyans, E. A. Ezquerra, C. Baigent, C. Brotons, G. Burell, A. Ceriello, J. De Sutter, J. Deckers, S. Del Prato, H.-C. Diener, D. Fitzsimons, Z. Fras, R. Hambrecht, P. Jankowski, U. Keil, M. Kirby, M. L. Larsen, G. Mancia, A. J. Manolis, J. Mcmurray, A. Pajak, A. Parkhomenko, L. Rallidis, F. Rigo, E. Rocha, L. M. Ruilope, E. Van Der Velde, D. Vanuzzo, M. Viigimaa, M. Volpe, O. Wiklund, C. Wolpert, "European Guidelines on cardiovascular disease prevention in clinical practice (version 2012): The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts) * Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR)", European Heart Journal, Oxford University Press, GB, GB , (20120701), vol. 33, no. 13, doi:10.1093/eurheartj/ehs092, ISSN 0195-668X, pages 1635 - 1701, XP055612791 | |
| OPPOSITION | - Trevor A Mori et al, "The Independent effects of eicosapentaenoic acid and docosahexaenoic acid on cardiovascular risk factors in humans", Curr Opinion Clin nitr metab care, (2006), vol. 9, doi:10.1097/01.mco.0000214566.67439.58, XP055828598 | |
| OPPOSITION | - Braeckman Rene, Manku Mehar S, Ballantyne Christie M, Stirtan William G, Soni Paresh N, "Abstract 18549: Effects of AMR101, a Pure Eicosapentaenoic Omega-3 Fatty Acid, on the Fatty Acid Profile in Plasma and Red Blood Cells in Statin-Treated Patients With Persistent High Triglycerides (Results from the ANCHOR Study)", Circulation, American Heart Association, US, US , (20121120), vol. 126, no. suppl_21, doi:10.1161/circ.126.suppl_21.A18549, ISSN 0009-7322, page A18549, XP093279114 | |
| OPPOSITION | - Matsuzaki, "Incremental Effects of Eicosapentaenoic Acid on Cardiovascular Events in Statin-Treated Patients With Coronary Artery Disease.", Circulation Journal, (20090101), vol. 73, doi:10.1253/circj.CJ-08-1197, pages 1283 - 1290, XP055181321 | |
| OPPOSITION | - Anonymous, "Scientific Opinion on the Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA)", EFSA journal, European Food Safety Authority, Parma, Italy, Parma, Italy, (20120701), vol. 10, no. 7, doi:10.2903/j.efsa.2012.2815, ISSN 1831-4732, page 2815, XP093279143 | |
| SEARCH | - Christie M Ballantyne; Harold E Bays; John J Kastelein; Evan A Stein; Jonathan Isaacsohn; Rene A Braeckman; Paresh N Soni, "Abstract 15071: AMR101 Lowers Triglycerides, Atherogenic Lipoprotein, Phospholipase A2, and High-sensitivity C-reactive Protein Levels in Patients With High Triglycerides and on Background Statin Therapy (the ANCHOR Study)", (20111122), URL: http://circ.ahajournals.org/cgi/content/meeting_abstract/124/21_MeetingAbstracts/A15071, (20160105), XP002752620 [A] 1-7 * the whole document * | - |
