Phase III CV outcomes trial with fish oil in dyslipidemia patients discontinued
The phase III STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridemia (STRENGTH) trial with a fish oil derived mixture of primarily EPA and DHA (omega-3 carboxyl acids) is discontinued due to a low likelihood to show benefit for patients with mixed dyslipidemia (MDL) and at high risk for CVD. This decision was made following the recommendation from an independent Data Monitoring Committee.
The STRENGTH trial is a large-scale, global CV outcomes trial designed to evaluate the safety and the effect of a fish oil-derived mixture of free fatty acids primarily composed of EPA and DHA 4g daily compared to placebo (corn oil) on reducing the risk of major adverse cardiovascular events (MACE) in MDL patients at high risk for CVD on optimal statin therapy. A total of 13,086 MDL patients with raised triglyceride levels (moderate hypertriglyceridemia) between 175-499mg/dL and low HDL cholesterol were enrolled at 675 sites in 22 countries.
This mixture of omega-3 carboxylic acids is approved in the US and indicated to reduce triglyceride levels in adults with severe hypertriglyceridemia (≥500 mg/dL). The data from the STRENGTH trial have no impact on this indication. Full data of the STRENGTH trial will be presented at a forthcoming medical meeting.