PMID- 24314359 OWN - NLM STAT- MEDLINE DCOM- 20140724 LR - 20221207 IS - 1933-2874 (Print) IS - 1876-4789 (Linking) VI - 7 IP - 6 DP - 2013 Nov-Dec TI - Long-term safety and efficacy of TAK-085 in Japanese subjects with hypertriglyceridemia undergoing lifestyle modification: the omega-3 fatty acids randomized long-term (ORL) study. PG - 615-25 LID - S1933-2874(13)00281-X [pii] LID - 10.1016/j.jacl.2013.09.002 [doi] AB - BACKGROUND: TAK-085 is an omega-3 preparation that contains eicosapentaenoic acid ethyl-ester (EPA-E) and docosahexaenoic acid-ethyl ester used in the management of hypertriglyceridemia. OBJECTIVE: The aim of the study was to evaluate the long-term safety (adverse events [AEs], laboratory parameters, vital signs, weight, and electrocardiograms) and effects on lipid profiles, especially triglyceride levels, of TAK-085 in Japanese patients with hypertriglyceridemia (triglyceride levels >/=150 mg/dL and <750 mg/dL). METHODS: In this multicenter, open-label, randomized study, adults with hypertriglyceridemia undergoing lifestyle modification received TAK-085 2 g (2 g once daily; n = 165) or 4 g (2 g twice daily; n = 171), or EPA-E 1.8 g (0.6 g three times daily; n = 167) for 52 weeks. Patients were stratified for co-administration of a statin. RESULTS: TAK-085 was well tolerated throughout the 52-week study. Overall, no substantial differences were found in the tolerability of TAK-085 2 g, TAK-085 4 g, and EPA-E 1.8 g with incidence rates for AEs of 83.6%, 86.0%, and 89.2%, respectively. Most AEs were mild or moderate in severity. Triglyceride levels decreased from baseline in all groups by week 4, and the decreases were maintained throughout the study. At week 52 the reduction in triglycerides with TAK-085 2 g (-13.9%) was similar to that with EPA-E 1.8 g (-12.1%), whereas the reduction seen with TAK-085 4 g (-25.5%) was greater than that with EPA-E 1.8 g, as assessed by point estimates and 95% confidence intervals. CONCLUSIONS: TAK-085 was safe and well tolerated for up to 52 weeks of treatment in Japanese patients with hypertriglyceridemia undergoing lifestyle modification. Reductions in triglyceride levels achieved after 4 weeks were maintained at 52 weeks. CI - Copyright (c) 2013 National Lipid Association. Published by Elsevier Inc. All rights reserved. FAU - Tatsuno, Ichiro AU - Tatsuno I AD - Center for Diabetes, Metabolism and Endocrinology, Toho University Sakura Medical Center, Chiba 285-8741, Japan. Electronic address: ichiro.tatsuno@med.toho-u.ac.jp. FAU - Saito, Yasushi AU - Saito Y FAU - Kudou, Kentarou AU - Kudou K FAU - Ootake, Jun AU - Ootake J LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130918 PL - United States TA - J Clin Lipidol JT - Journal of clinical lipidology JID - 101300157 RN - 0 (Drug Combinations) RN - 0 (Fatty Acids, Omega-3) RN - 0 (Hypolipidemic Agents) RN - 0 (TAK-085) RN - 25167-62-8 (Docosahexaenoic Acids) RN - AAN7QOV9EA (Eicosapentaenoic Acid) SB - IM MH - Adult MH - Aged MH - Asian People MH - *Diet MH - Docosahexaenoic Acids/*therapeutic use MH - Drug Administration Schedule MH - Drug Combinations MH - Eicosapentaenoic Acid/*analogs & derivatives/therapeutic use MH - Fatty Acids, Omega-3/*therapeutic use MH - Female MH - Humans MH - Hypertriglyceridemia/*drug therapy MH - Hypolipidemic Agents/*therapeutic use MH - Japan MH - Life Style MH - Male MH - Middle Aged MH - Treatment Outcome OTO - NOTNLM OT - Docosahexaenoic acid OT - Dyslipidemia OT - Eicosapentaenoic acid OT - Hypertriglyceridemia OT - Omega-3 fatty acid OT - TAK-085 EDAT- 2013/12/10 06:00 MHDA- 2014/07/25 06:00 CRDT- 2013/12/10 06:00 PHST- 2013/05/27 00:00 [received] PHST- 2013/08/12 00:00 [revised] PHST- 2013/09/12 00:00 [accepted] PHST- 2013/12/10 06:00 [entrez] PHST- 2013/12/10 06:00 [pubmed] PHST- 2014/07/25 06:00 [medline] AID - S1933-2874(13)00281-X [pii] AID - 10.1016/j.jacl.2013.09.002 [doi] PST - ppublish SO - J Clin Lipidol. 2013 Nov-Dec;7(6):615-25. doi: 10.1016/j.jacl.2013.09.002. Epub 2013 Sep 18.