title: 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.
abstract: 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.
authors: Center for Diabetes, Metabolism and Endocrinology, Toho University Sakura Medical Center, Chiba 285-8741, Japan. Electronic address: ichiro.tatsuno@med.toho-u.ac.jp.
authors: Ichiro
authors: I
authors: Tatsuno
authors: Yasushi
authors: Y
authors: Saito
authors: Kentarou
authors: K
authors: Kudou
authors: Jun
authors: J
authors: Ootake
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D004032:Diet; D004281:Docosahexaenoic Acids / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015228:Hypertriglyceridemia / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D007564:Japan; D008019:Life Style; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D015525:Fatty Acids, Omega-3; D000960:Hypolipidemic Agents; C587319:TAK-085; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid
keywords: Docosahexaenoic acid; Dyslipidemia; Eicosapentaenoic acid; Hypertriglyceridemia; Omega-3 fatty acid; TAK-085