scholarly journals Benefits of prolonged-release pirfenidone plus standard of care treatment in patients with advanced liver fibrosis: PROMETEO study

2020 ◽  
Vol 14 (5) ◽  
pp. 817-827
Author(s):  
Jorge Luis Poo ◽  
Aldo Torre ◽  
Juan Ramón Aguilar-Ramírez ◽  
Mauricio Cruz ◽  
Luis Mejía-Cuán ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Liver Disease ◽  
Liver Fibrosis ◽  
Transient Elastography ◽  
Standard Of Care ◽  
Prolonged Release ◽  
Release Formulation ◽  
Viral Hepatitis C ◽  
Advanced Liver Fibrosis

Abstract Background and aims Pirfenidone (PFD), an oral antifibrotic drug, has been authorized by the EMA and FDA for treatment of idiopathic pulmonary fibrosis. Few studies have addressed its use in advanced liver fibrosis (ALF). We evaluated a prolonged-release formulation (PR-PFD) plus standard of care on disease progression in ALF. Methods 281 ALF patients from 12 centers receiving PR-PFD (600 mg bid) were screened; 122 completed 1 year of treatment. Additionally, 74 patients received only standard of care regimen. Average age was 64 ± 12 years, 58% female. 43.5% had fatty liver disease (NAFLD), 22.5% viral hepatitis C (VHC), 17% autoimmune hepatitis (AIH), and 17% alcoholic liver disease (ALD). Baseline fibrosis was F4 in 74% and F3 in 26%. Antifibrotic effects were assessed by transient elastography (Fibroscan®) and Fibro Test® (FT); Cytokines and PFD plasma levels were tracked and quality of life evaluated. Results We found a significant reduction in fibrosis in 35% of PR-PFD patients and only in 4.1% in non PR-PFD patients. Child–Pugh score improved in 29.7%. Biochemical values remained stable; 40.6% and 43.3% decreased ALT or AST, respectively. TGFβ1 (pg/mL) levels were lower in PFD-treated patients. PFD serum concentration (µg/mL) was higher (8.2 ± 1.7) in fibrosis regression profile (FRP) patients compared to fibrosis progression profile (FPP) patients (4.7 ± 0.3 µg/mL, p < 0.01). 12% reported transient burning or nausea and 7% photosensitivity. Quality of life (Euro-Qol scale) improved from 62 ± 5 to 84 ± 3 (p < 0.001) and from 32 ± 3 to 42 ± 2 (p < 0.008) (FACIT scale). Conclusions PR-PFD is efficacious and safe in ALF and associated with promising antifibrotic effects. Trial registration Clinical trial number: NCT04099407.

PS-187-Transient elastography is the most reliable non-invasive predictor of advanced liver fibrosis in fontan-associated liver disease: The VALDIG FONLIVER study

2019 ◽  
Vol 70 (1) ◽  
pp. e115-e116
Author(s):  
Luis Téllez ◽  
Payance Audrey ◽  
Valérie Paradis ◽  
Enrique Rodríguez-Santiago ◽  
Aurélie Plessier ◽  
...  
Keyword(s):  
Liver Disease ◽  
Liver Fibrosis ◽  
Transient Elastography ◽  
Non Invasive ◽  
Advanced Liver Fibrosis

scholarly journals Antioxidant Lifestyle, Co-Morbidities and Quality of Life Empowerment Concerning Liver Fibrosis

Antioxidants ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. 1125
Author(s):  
Diego Martinez-Urbistondo ◽  
Rafael Suarez del Villar ◽  
Josepmaria Argemí ◽  
Lidia Daimiel ◽  
Omar Ramos-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Liver Disease ◽  
Liver Fibrosis ◽  
Demographic Data ◽  
Univariate Analysis ◽  
Multivariable Analysis ◽  
Alcoholic Fatty Liver ◽  
Co Morbidity ◽  
Sf 36

The assessment of liver fibrosis has gained importance since the progression of non-alcoholic fatty liver disease (NAFLD). Indeed, the description of the association between undetected liver fibrosis and lifestyle in terms of antioxidant habits, comorbidity and quality of life (QoL) domains may help in the characterization of subjects with NAFLD. A cross-sectional evaluation of (n = 116) consecutive patients from an Internal Medicine ambulatory evaluation was performed. Demographic data, lifestyle, co-morbidity, QoL (according to the SF-36 index) and analytical values to calculate the oxidative related Fibrosis-4 (FIB-4) index were recorded. The association between FIB-4 and co-morbidity, antioxidant habits in QoL was assessed in univariate analysis (p < 0.05) and confirmed in multivariable analysis for 4 of the 8 SF-36 categories: Physical QoL, Physical role, Social QoL and General QoL, as well as in the Physical summary of SF-36 (p < 0.05). Finally, interactions were assessed between co-morbidity, FIB-4 and antioxidant habits showed in the prediction of mean SF-36 (p < 0.01). Liver fibrosis assessed by the oxidative surrogate index FIB-4 is associated with the interaction between antioxidant lifestyle, co-morbidity and physical, social and general aspects of QoL in apparent liver disease-free individuals, generating a proof of concept for health empowerment and personalized medicine.

scholarly journals Liver Dysfunction may be Associated with QOL in Adults with CF

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Megana Rao, BS ◽  
Regina Weber, BS ◽  
Naga Chalasani, MD
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Alkaline Phosphatase ◽  
Liver Disease ◽  
Transient Elastography ◽  
Liver Stiffness ◽  
Future Research ◽  
Co Morbidity ◽  
The Mean

Background: More individuals with cystic fibrosis (CF) are living into their adulthood due to significant advances in medical care. The adult CF clinic at Indiana University cares for one of the largest adult populations with CF. Liver disease is common in children and adults with CF. However, the characteristics and consequences of CF liver disease (CFLD) in adults are not well understood. In this ongoing, IRB approved study, we systematically characterized the liver manifestations and their health related quality of life in adults with well characterized CF. Methods: Individual patient demographics and clinical data were collected for study participants. Participants completed two quality of life study questionnaires: Chronic Liver Disease Questionnaire (CLDQ) and Revised Cystic Fibrosis Questionnaire (CFQ-R). 10mL of blood was collected for future research. Finally, participants underwent a bedside transient elastography via FibroScan®. Results: There were 50 patients, with a mean age of 30.9 years, enrolled in the study. Pancreatic insufficiency was the most common co-morbidity, as it affected 90% of patients. The mean AST was 23.55 units/L, mean ALT was 25.20 units/L, and mean alkaline phosphatase level was 117.73 units/L. From the FibroScan®, the median liver stiffness measurement (LSM) was 4.65 kPa and the mean controlled attenuation parameter (CAP) was 219.52 dB/M. The mean CLDQ score was 5.343. Conclusion: This ongoing study reveals that increased alkaline phosphatase and CAP scores are associated with a poor QOL. More data is needed to further understand the pathophysiology behind CFLD. Use of noninvasive imaging, noninvasive markers, and the CLDQ may aid in early identification of adult CFLD.    

scholarly journals Clinical efficacy of Heptrong in patients with non-alcoholic liver disease in real clinical practice (pilot study)

2020 ◽  
pp. 109-118
Author(s):  
I. Yu. Pirogova ◽  
S. P. Sinitsyn ◽  
V. S. Chulkov
Keyword(s):  
Quality Of Life ◽  
Insulin Resistance ◽  
Liver Disease ◽  
Liver Fibrosis ◽  
Total Cholesterol ◽  
Clinical Efficacy ◽  
Liver Steatosis ◽  
Response To Therapy ◽  
Homa Index

The purpose of the study: to assess clinical efficacy, dynamics of liver steatosis, effect on insulin resistance and hypolipidemic, ammonia level, systemic inflammation of the Heptrong in patients with non-alcoholic fatty liver disease (NAFLD) and dyslipidemia with obesity.Materials and methods. The study included 40 patients (23 men), age Me 48 (41–53) years, BMI Me 30.5 (28–34) kg / sqm. Inclusion criterion: presence of fatty hepatosis in ultrasound and the ALT level is more than 1.5 norms. Asthenia (AVS) was detected in 78% of patients, abdominal pain in 65% (hepatomegaly, chronic cholecystitis), flatulence in 26%, dyspepsia in 32%. In 36% of patients there was arterial hypertension, in 54% of cases — insulin resistance, in 72% of cases — dyslipidemia with hypertriglyceridemia. Before therapy, patients had an increase in the level of ALT up to 1.9 norms, AST up to 2.1 norms, GGTP up to 1.8 norms, total bilirubin — 1.4 norms, glycated hemoglobin — 1.2 norms, HOMA index up to 1,3 norms, total cholesterol up to 1.3 norms, triglycerides up to 1.4 norms, CRP up to 1.2 norms and ferritin up to 1.3 norms, combined with an increase in CRP and leukocytes up to 1.2 norms. According to the results of liver FIBROSCAN, hepatic steatosis was detected in all patients, Me CAP 295 (254–343), liver fibrosis was detected in 32% of cases (Me 6.4 (5.4–7.6) kPa). The level of ammonia in the peripheral blood on an empty stomach was Me 72 (42–91) mmol / l (with a norm of up to 54 mmol / l). Heptrong was prescribed in the form of 3 courses of 10 intramuscular injections according to the scheme 3.0 ml-3 ml-6.0 ml-6.0 ml-9.0 ml-9.0 ml-6.0 ml-6.0 ml-3.0 ml-3.0 ml for 3 months.Resaults. After 1 month of Heptrong therapy according to the scheme, there was a significant decrease (p≤0.05 according to the Wilcoxon criterion) in the frequency of AVS, pain and dyspeptic syndrome, the level of bilirubin, ALT, CRP, ferritin, ammonia, GGTP. After 3 courses of therapy, the examined patients showed further regression of clinical syndromes. During examination and communication, a positive trend was noted on the scales of quality of life and level of anxiety. Revealed a decrease in Me ALT by 31% (p <0.05); decrease in AST by 28% (p <0.05); GGTP — by 33% (p <0.05); glycated HB — by 15% (p <0.05); CRP — by 10% (p <0.03) ; ferritin — by 11% (p <0.05), ammonia — by24% (p <0.05); HOMA — index by 15% (p <0.04); total cholesterol — by 12% (p <0.05); triglycerides — by 20% (p <0.05); LDL — by 19% (p <0.05); HDL + 18% (p <0.05); Liver steatosis (dВ / m²) –26% (p <0.05); Liver fibrosis — reduction of 1 stage (Metavir) in 28% of patients. A positive response to therapy correlated (r> 0.3) with the patient’s age, male gender, BMI, Homa index, LDL, CRP, ammonia, ferritin.Conclusions. During the course of treatment with Heptrong, patients with NAFLD experience regression of clinical symptoms, stigma of systemic and local inflammation, correction of metabolic disorders, and improvement in the quality of life.

scholarly journals Prediction of Nonalcoholic Fatty Liver Disease Using Noninvasive and Non-Imaging Procedures in Japanese Health Checkup Examinees

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 132
Author(s):  
Kenichiro Murayama ◽  
Michiaki Okada ◽  
Kenichi Tanaka ◽  
Chika Inadomi ◽  
Wataru Yoshioka ◽  
...  
Keyword(s):  
Liver Disease ◽  
Liver Fibrosis ◽  
Fatty Liver ◽  
Japanese Population ◽  
Fatty Liver Disease ◽  
Health Checkup ◽  
Nonalcoholic Fatty Liver ◽  
General Japanese Population ◽  
Advanced Liver Fibrosis ◽  
Zju Index

Access to imaging is limited for diagnosing nonalcoholic fatty liver disease (NAFLD) in general populations. This study evaluated the diagnostic performance of noninvasive and nonimaging indexes to predict NAFLD in the general Japanese population. Health checkup examinees without hepatitis virus infection or habitual alcohol drinking were included. Fatty liver was diagnosed by ultrasonography. The hepatic steatosis index (HSI), Zhejiang University (ZJU) index, and fatty liver index (FLI) were determined, and risk of advanced liver fibrosis was evaluated by the fibrosis-4 index. NAFLD was diagnosed in 1935 (28.0%) of the 6927 subjects. The area under the receiver operating characteristic (AUROC) curve of the HSI, ZJU index, and FLI was 0.874, 0.886, and 0.884, respectively. The AUROC of the ZJU index (p < 0.001) and FLI (p = 0.002) was significantly greater than that for the HSI. In subjects with a high risk of advanced fibrosis, the sensitivity of the HSI, ZJU index, and FLI were 88.8%, 94.4%, and 83.3% with a low cut-off value and the specificity was 98.5%, 100%, and 100% with a high cut-off value. In conclusion, all indexes were useful to diagnose NAFLD in the general Japanese population and in subjects with potentially advanced liver fibrosis.

Superabsorbent Wound Dressing for Management of Patients With Moderate-to-Highly Exuding Chronic Leg Ulcers: An Early Stage Model-Based Benefit–Harm Assessment

2021 ◽  
pp. 153473462110093
Author(s):  
Vladica M. Velickovic ◽  
Jean P. Lembelembe ◽  
Francisco Cegri ◽  
Ivana Binic ◽  
Amr B. Abdelaziz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Early Stage ◽  
Absolute Risk ◽  
Standard Of Care ◽  
Risk Difference ◽  
Wound Dressings ◽  
Leg Ulcers ◽  
Related Quality ◽  
Health Related

The aim of the research is to assess the benefit–harm of superabsorbent polymers wound dressings based on polyacrylate polymers (SAPs) compared with standard of care (SoC) dressing mix for patients with moderate-to-highly exuding hard-to-heal leg ulcers. The SoC dressings mix was composed of other superabsorbents in 29% of cases, antimicrobials 26%, foams 20%, alginates 5%, and other dressings 19% weighted according to their frequency. We have used the decision-analytic modeling method, Markov process, as an adequate analytical solution for medical prognosis. We have combined the systematic literature search to identify the most relevant inputs for the analysis, with available patient-level clinical data concerning benefits of superabsorbent to generate a robust prediction of patient-relevant outcomes, including healing rates and health-related quality of life. Besides, we have qualitatively described adverse events associated with those treatments. Our research indicates that SAPs when compared with SoC dressing mix in a patient with moderate-to-highly excluding leg ulcers are leading to an improved healing rate with an absolute risk difference of 2.20% in 6 months and a relative risk of 1.07 in favor of SAP dressings. The attributable fraction among those exposed to SAP dressings of 6.6%, meaning that 6.6% of the healed ulcers could be attributed to having had the SAP dressing treatment instead of the SoC dressing treatment. Besides, SAP dressings lead to improved quality of life measured as incremental quality-adjusted life weeks (QALWs) of 0.13 QALWs.

Early kidney dysfunction in non-alcoholic fatty liver disease - is transient elastography useful as a screening method?

2021 ◽  
Author(s):  
Marta Freitas ◽  
Vítor Macedo Silva ◽  
Sofia Xavier ◽  
Joana Magalhes ◽  
Carla Marinho ◽  
...  
Keyword(s):  
Liver Disease ◽  
Liver Fibrosis ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Transient Elastography ◽  
Screening Method ◽  
Kidney Dysfunction ◽  
Alcoholic Fatty Liver ◽  
Increased Risk ◽  
Significant Liver Fibrosis

Introduction: Increasing evidence suggests an association between metabolic associated fatty liver disease (MAFLD) and chronic kidney disease (CKD). Timely prediction of early kidney dysfunction (EKD) is thus essential in this population, although a screening method is not stablished. We aimed to evaluate the role of transient elastography (TE) in predicting EKD in patients with MAFLD. Methods: Prospective cohort study that included patients with MAFLD scheduled for evaluation, between May/2019 and January/2020. Demographic, clinical and laboratory data, and TE parameters were obtained. EKD was defined as microalbuminuria (urinary albumin-to-creatinine ratio 30-300mg/g) and estimated glomerular filtration rate≥60mL/min/1.73m2. Significant liver fibrosis was defined as liver stiffness measurement (LSM)≥8.2kPa. Results: Included 45 patients with MALFD, 53.3% female gender, mean age of 53.5±10.9years. EKD was found in 17.8% of patients. MAFLD patients with EKD were significantly more obese (body mass index≥30) (75.0% vs 32.4%,p=0.045) and had significantly higher LSM (8.5±4.1 vs 5.8±2.2kPa,p=0.01). After adjustment of potential confounders for EKD the presence of liver fibrosis, remained a significant predictor of EKD, being associated with a 14.3-fold increased risk of EKD (p=0.04). The optimal cutoff value of LSM to predict EKD was 6.1kPa (sensitivity:85.7%; specificity:67.6%). Conclusion: Significant liver fibrosis is associated with a significant increased risk of EKD in patients with MAFLD, regardless of other comorbidities. Higher levels of LSM, particularly >6.1kPa, alert for timely identification of EKD and associated comorbidities, as well as their control, in order to prevent the development of CKD in the long term.

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