How to explain positive results of REDUCE-IT and neutral outcome of STRENGTH? It’s possible that attained plasma EPA levels account for a good part of the difference. #AHA20 /1
Achieved median EPA levels were ~90% higher in JELIS and REDUCE-IT v STRENGTH (JELIS due to higher baseline of Japanese population despite lower dose).
Higher achieved EPA correlates with higher benefit in REDUCE-IT (& JELIS). Lowest tertile EPA HR=0.85, highest=0.63 /2
Achieved median EPA levels were ~90% higher in JELIS and REDUCE-IT v STRENGTH (JELIS due to higher baseline of Japanese population despite lower dose). Higher achieved EPA correlates with higher benefit in REDUCE-IT (& JELIS). Lowest tertile EPA HR=0.85, highest=0.63 /2
Achieved median EPA levels were ~90% higher in JELIS and REDUCE-IT v STRENGTH (JELIS due to higher baseline of Japanese population despite lower dose). Higher achieved EPA correlates with higher benefit in REDUCE-IT (& JELIS). Lowest tertile EPA HR=0.85, highest=0.63 /2
Achieved median EPA levels were ~90% higher in JELIS and REDUCE-IT v STRENGTH (JELIS due to higher baseline of Japanese population despite lower dose). Higher achieved EPA correlates with higher benefit in REDUCE-IT (& JELIS). Lowest tertile EPA HR=0.85, highest=0.63 /2
What about that analysis of STRENGTH by percent change in plasma EPA? It doesn’t directly address the possibility of greater benefit by attained EPA levels. Many in the high % change group could be those at low baseline reaching moderate EPA levels. /3
some other trial differences:
(*)Signal of benefit stronger in secondary prevention population. 71% in REDUCE-IT in this subgroup, 56% in STRENGTH.
(*)Benefit in REDUCE-IT expanded over time. Median follow-up shorter in STRENGTH 3.5yr v REDUCE-IT 4.9yr. /4
some other trial differences: (*)Signal of benefit stronger in secondary prevention population. 71% in REDUCE-IT in this subgroup, 56% in STRENGTH. (*)Benefit in REDUCE-IT expanded over time. Median follow-up shorter in STRENGTH 3.5yr v REDUCE-IT 4.9yr. /4
some other trial differences: (*)Signal of benefit stronger in secondary prevention population. 71% in REDUCE-IT in this subgroup, 56% in STRENGTH. (*)Benefit in REDUCE-IT expanded over time. Median follow-up shorter in STRENGTH 3.5yr v REDUCE-IT 4.9yr. /4
(*)Agree lipid changes from baseline in MO placebo may account for a modest part of REDUCE-IT benefit.

Add’l caveat:JELIS is an imperfect trial - randomized but no placebo, positive on soft endpoints, low statin dose. /5-fin
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