This study’s aim was to assess the histological and metabolic effects of N-3 polyunsaturated fatty acids (PUFA) versus placebo while adjusting for the impact of age and weight change in NASH patients. (ClinicalTrials.gov: NCT00681408).
Methods
Forty-one subjects with non-cirrhotic NASH were enrolled, and 34 completed the study. 17 received N-3 fish oil 3000 mg/day and 17 received placebo daily for 1 year with typical counseling on caloric intake and physical activity for all subjects.
Results
N-3- and placebo-treated groups showed no significant difference for the primary endpoint of NAS reduction ≥ 2 points without fibrosis progression after adjustment for known covariates (N-3, 4/17 (23.5%); placebo, 3/17, (17.6%), p=0.99). Among subjects with increased or stable weight, N-3 subjects showed a larger decrease in liver fat content by MRI than placebo-treated subjects (p=0.014 for 2nd quartile, p=0.003 for 3rd quartile of weight change). N-3 treatment showed significant fat reduction on paired analysis of image-assisted fat morphometry regardless of weight loss or gain. Exercise capacity remained markedly reduced in all subjects. No independent effects on markers of hepatocyte injury or insulin sensitivity indices were observed.
Conclusion
N-3 PUFA at 3000 mg/day for one year did not lead to improvement in the primary outcome of histological activity in NASH patients (≥ 2 point NAS reduction). N-3 led to reduced liver fat by multiple measures. Other metabolic effects were not seen, although no detrimental effects were apparent. Whether longer duration, higher dose, or different composition of N-3 therapy would lead to additional benefit is uncertain.
Stable cirrhosis 228 patients enrolled at Medical University of Graz Acute decompensation 280 patients enrolled in CANONIC cohort including 107 patients with ACLF Measurement of HDL-related biomarkers (HDL-C, apoA-I) at baseline Highlights HDL levels are profoundly decreased in chronic liver failure. HDL-related biomarkers (HDL-C, apoA-I) are robust predictors of disease progression and survival. The prognostic value of single HDL-related biomarkers is very similar to that of the composite scores. HDL-related biomarkers correlated inversely with markers of inflammation.
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Summary
Background
Anti‐TNF antibodies were the first biologic treatment option for patients with inflammatory bowel diseases.
Aims
To assess length of treatment persistence of first anti‐TNF therapy and influencing factors used in the standard care of patients with inflammatory bowel diseases.
Methods
Single‐centre, retrospective study from a register including patients who received anti‐TNF therapy in the last 20 years at the study centre. Kaplan‐Meier analysis with log‐rank test was used to describe treatment persistence. With multivariable Cox regression analysis, risk factors for treatment failure were investigated.
Results
Five hundred thirty‐eight patients (CD, Crohn's disease: 367, UC, ulcerative colitis: 147, inflammatory bowel disease unclassified: 24) with a median follow‐up of 8.1 years were included. Median (95% confidence interval) treatment persistence in the total cohort was 2.3 years (28 [22, 38] months), and nearly half of patients withdrew from treatment within 2 years. Male patients were treated longer than females (male: 37 [25, 48] months, female: 23 [14, 33] months, P = 0.002). Treatment persistence was longer in CD compared to UC (CD: 39 [30, 50] months, UC: 13 [9, 19] months, P < 0.001), and patients with CD remained longer on adalimumab than on infliximab treatment (adalimumab: 67 [55, 95] months, infliximab: 19 [14, 31] months, P < 0.001). Treatment failure (52%) and side effects (25%) were the most common reasons for withdrawal from therapy; 14% withdrew due to remission. Female sex was identified as independent predictor for treatment failure in UC (hazard ratio [CI]: 1.73 [1.02‐2.92], P = 0.04).
Conclusion
Long‐term treatment persistence of first anti‐TNF therapy was limited in patients with inflammatory bowel diseases, primarily due to treatment failure and side effects.
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