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Eicosapentaenoic Acid Reduces Fecal Levels of Calprotectin and Prevents Relapse in Patients With Ulcerative Colitis.

Artigo em Inglês | MEDLINE | ID: mdl-29391271
BACKGROUND & AIMS: High fecal levels of calprotectin indicate mucosal inflammation and have been shown to predict relapse in patients with ulcerative colitis (UC). Eicosapentaenoic acid (EPA), the major component of n-3 fish oil, has anti-inflammatory properties in patients with chronic inflammatory disorders. We performed a placebo-controlled trial of patients with UC at risk of relapse to determine the ability of the free-fatty acid form of EPA (EPA-FFA) to reduce intestinal inflammation, using fecal level of calprotectin as a marker.

METHODS:

From June 2014 to May 2016, 60 patients with UC with partial Mayo score < 2 and FC ≥150 µg/g, in stable therapy for at least the 3 previous months, were randomly assigned to groups (1:1) given either EPA-FFA (500 mg, twice daily) or placebo for 6 months. A colonoscopy was performed at baseline. Clinical assessments and measurements of fecal calprotectin were made at baseline, at study 3 and 6 months, or the time of clinical relapse. Patients with a relapse of UC underwent a second colonoscopy. The primary endpoint was a 100-point reduction in fecal levels of calprotectin at 6 months from the baseline value; the secondary endpoint was maintenance of clinical remission at 6 months.

RESULTS:

The primary endpoint was achieved by 19/30 patients (63.3%) in the EPA-FFA group vs 4/30 patients (13.3%) in the placebo group (odds ratio, 12.0; 95% CI, 3.12-46.24) (P<.001). The secondary endpoint was achieved by 23/30 patients (76.7%) in the EPA-FFA group vs 15/30 (50%) patients in the placebo group (OR, 3.29; 95% CI, 1.08-9.95) (P=.035). No serious adverse events were observed.

CONCLUSION:

In a placebo-controlled trial of 60 patients with UC, we found 6 months administration of EPA-FFA to reduce fecal levels of calprotectin with no serious adverse events. This agent might be used to induce and maintain symptom-free remission in patients with UC. ClinicalTrials.gov number: NCT02179372.