STRENGTH randomized 13,078 statin-treated high-risk adults to a 4 g/day EPA+DHA carboxylic-acid formulation or corn oil and was stopped early for futility after 1,384 of a planned 1,600 primary events. The composite cardiovascular endpoint did not differ significantly (12.0% vs 12.2%, hazard ratio 0.99, 95% CI 0.90-1.09, P=.84), and gastrointestinal adverse events were more frequent with the active formulation (24.7% vs 14.7%). Results from this EPA+DHA product versus corn oil should not be generalized to a different EPA-only prescription product or to all fish-oil supplements.[1]
- Formulation, comparator (corn oil) and population differ from REDUCE-IT (icosapent ethyl vs mineral oil) and from typical retail fish oil.
- Abstract-checked; no qualified clinical review.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.
· Reopened the PubMed structured abstract via E-utilities and added exact event rates, HR/CI/P values and adverse-event rates. Attempted PMC full text (PMC7667577) twice; both attempts failed (bot-check interstitial; BioC endpoint returned no result). Remains abstract-checked. Independent editorial review pending; no qualified clinical review.