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. 2018 Jul 18;2018(7):CD003177. doi: 10.1002/14651858.CD003177.pub3

ORL 2013

Methods Omega‐3 fatty acids randomised long‐term (ORL)
RCT‐ parallel, 3 arms (TAK‐085 2 g, TAK‐085 4 g, and EPA‐E 1.8 g), 12 months
Summary risk of bias: moderate or high
Participants Population: Japanese adults with hypertriglyceridaemia
N: 171 intervention (4 g TAK), 165 control (2 g TAK)
Level of risk for CVD: moderate
Men: 70.8% intervention, 71.5% control
Mean age in years (SD): 55.9 (10.12) intervention, 56 (10.95) control
Age range: 20‐74
Smokers (current): 27.5% intervention, 31.5% control
Hypertension: 66.7% intervention, 67.3% control
Medications taken by at least 50% of those in the control group: HMG‐CoA reductase inhibitor
Medications taken by 20%‐49%: statin
Medications taken by some, but less than 20%: not reported
Location: Japan
Ethnicity: unclear
Interventions Type: supplement (TAK‐085 capsules)
Comparison: EPA + DHA higher vs lower dose
Intervention: 1 × 2/d capsule each containing 2 g of TAK‐085 (1 g of fatty acid in TAK‐085 capsules contains approximately 465 mg of EPA‐E plus 375 mg of DHA‐E). Total dose of 1.86 g/d EPA + 1.5 g/d DHA. Dose: ˜3.4 g/d EPA + DHA) (difference of +1.7 g/d from control arm)
Control: 1 capsule/d containing 2 g of TAK‐085 (1 g of fatty acid in TAK‐085 capsules contains approximately 465 mg of EPA‐E plus 375 mg of DHA‐E). Total dose of 0.93 g/d EPA + 0.75 g/d DHA. Dose: 1.7 g/d EPA + DHA
Compliance: monitored every 4 weeks, mean rate of compliance reported as > 96% in each group
Length of intervention: 12 months
Outcomes Main study outcome: safety outcomes and adverse events
Dropouts: group 1: 8, group 2: 14, group 3 (not analysed): 21
Available outcomes: adverse events (including CVD events, cancers), CRP, waist circumference, weight, blood pressure (nil death), lipids provided as % change from baseline, but no baseline data available, so not used in meta‐analyses
Response to contact: no
Notes A third arm of EPA‐E 1.8 g supplementation is not used here. Outcome data used TAK‐4 vs TAK‐2
Study funding: Takeda Pharmaceutical Company
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was stratified according to statin use and performed by an independent registration centre
Allocation concealment (selection bias) Low risk As above
Blinding of participants and personnel (performance bias) All outcomes High risk Open label
Blinding of outcome assessment (detection bias) All outcomes High risk Open label
Incomplete outcome data (attrition bias) All outcomes Low risk All participants were accounted for and analysed for main outcomes
Selective reporting (reporting bias) Low risk Trials registry entry May 2011, study start date November 2009, completion November 2011, so partially retrospective. However, entry appears to reflect reported outcomes.
Attention Low risk Capsules, appears similar
Compliance Low risk Monitored every 4 weeks, mean rate of compliance reported as > 96% in each group
Other bias Low risk None noted