Effect of icosapent ethyl treatment on colorectal tissue marine ω-3 polyunsaturated fatty acid levels among patients with a history of adenoma: a prospective, single-arm clinical trial
Abstract
Background: Icosapent ethyl (IPE), an ethyl ester of eicosapentaenoic acid (EPA; C20:5n-3), is thought to have immunomodulatory properties and may protect against colorectal cancer.
Objectives: This study aimed to assess the effect of IPE on changing total marine omega-3 (n-3) polyunsaturated fatty acid (PUFA) and individual fatty acid composition in colorectal tissue.
Methods: We conducted a prospective, single-arm clinical trial of 4 g/d IPE (VASCEPA) treatment for 8 to 12 wk among patients with a recent history of adenoma. We collected pretreatment and posttreatment colorectal biopsies through flexible sigmoidoscopy and participants' diet and lifestyle via questionnaires. The primary outcome was the change in total marine ω-3 PUFA in colorectal tissue measured by gas-liquid chromatography. We examined changes in individual fatty acids exploratorily.
Results: Among a total of 81 patients enrolled, 72 had paired pretreatment and posttreatment tissue fatty acid data. After intervention, the tissue composition [median (interquartile range)] of total marine ω-3 PUFA increased from 2.10% (0.96%) to 5.21% (1.97%), with a fold change of 2.40 (0.82). With a slight decrease in ω-6 PUFA [fold change = 0.96 (0.27)], the ratio of marine ω-3 to ω-6 PUFA increased [fold change = 2.58 (0.81)]. Among individual fatty acids, EPA increased the most [fold change = 5.88 (3.63)]. The cumulative amount of IPE treatment, rather than daily dosage, showed a positive correlation with changes in…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 81 participants or records.
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