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Hepatology

Phase 2 RCT: Low-dose aspirin significantly reduces hepatic fat in MASLD patients without cirrhosis

20 Mar, 2024 | 17:48h | UTC

Study Design and Population: This phase 2, randomized, double-blind, placebo-controlled clinical trial was carried out over six months at a single hospital in Boston, Massachusetts. The study included 80 participants aged 18 to 70 years diagnosed with metabolic dysfunction–associated steatotic liver disease (MASLD) but without cirrhosis. Participants were randomly assigned to receive either 81 mg of daily aspirin (n=40) or placebo (n=40).

Main Findings: The trial revealed that aspirin significantly reduced the mean absolute change in hepatic fat content by -10.2% compared with placebo, as measured by proton magnetic resonance spectroscopy (MRS), with a statistically significant difference (P=0.009). Furthermore, aspirin treatment notably decreased relative hepatic fat content, increased the proportion of patients achieving a 30% or greater reduction in hepatic fat, and reduced both absolute and relative hepatic fat content as assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). Adverse events were mostly minor, with upper respiratory infections and arthralgias being the most common.

Implications for Practice: These findings suggest that low-dose aspirin may be an effective intervention for reducing liver fat in adults with MASLD without cirrhosis, potentially offering a simple, accessible treatment option. However, the results are preliminary and call for further confirmation in larger, more diverse populations. The study underscores the importance of considering low-dose aspirin as part of management strategies for MASLD, pending further research.

Reference

Simon TG et al. (2024). Randomized Clinical Trial: Low-Dose Aspirin Significantly Reduces Hepatic Fat in MASLD Patients Without Cirrhosis. JAMA, 331(11), 920-929. DOI: 10.1001/jama.2024.1215. Access the study here: [Link]


Perspective | Clinicians debate the usefulness of NAFLD name change

11 Aug, 2023 | 15:39h | UTC

Clinicians debate the usefulness of NAFLD name change – MDedge

Original article: From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

 


M-A | Percutaneous catheter drainage superior to needle aspiration for liver abscess treatment success

9 Aug, 2023 | 15:12h | UTC

Percutaneous catheter drainage versus percutaneous needle aspiration for liver abscess: a systematic review, meta-analysis and trial sequential analysis – BMJ Open

 


Clinical Trial Update | Long-term Givosiran treatment shows sustained acute hepatic porphyria symptom improvement

8 Aug, 2023 | 13:05h | UTC

Efficacy and safety of givosiran for acute hepatic porphyria: Final results of the randomized phase III ENVISION trial – Journal of Hepatology

Original Study: Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria – New England Journal of Medicine

 


Review | Diagnosis and management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome

4 Aug, 2023 | 11:50h | UTC

Diagnosis and management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome – Cleveland Clinic Journal of Medicine

 


Review | Non-alcoholic fatty liver disease: pathophysiological concepts and treatment options

1 Aug, 2023 | 14:19h | UTC

Non-alcoholic fatty liver disease: pathophysiological concepts and treatment options – Cardiovascular Research

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From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

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Updated S2k Clinical Practice Guideline on Non-alcoholic Fatty Liver Disease (NAFLD) issued by the German Society of Gastroenterology, Digestive and Metabolic Diseases (DGVS) – Zeitschrift für Gastroenterologie

AGA Clinical Practice Update | Diagnosis and management of nonalcoholic fatty liver disease in lean individuals.

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RCT | Bictegravir regimen noninferior to dolutegravir regimen in HIV-1, HBV co-infection treatment

31 Jul, 2023 | 14:00h | UTC

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24 Jul, 2023 | 12:57h | UTC

Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis – Cochrane Library

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20 Jul, 2023 | 10:59h | UTC

Hepatic, Extra-hepatic Outcomes and Causes of Mortality in NAFLD – An Umbrella Overview of Systematic Review of Meta-Analysis – Journal of Clinical and Experimental Hepatology

 


RCT | Midodrine show promise as an alternative to albumin for the prevention of circulatory disturbance in paracentesis between 3 and 5 L

18 Jul, 2023 | 13:47h | UTC

Midodrine versus Albumin to Prevent Paracentesis Induced Circulatory Dysfunction in Acute on Chronic Liver Failure Patients in the Outpatient Clinic–a Randomized Controlled Trial – Journal of Clinical and Experimental Hepatology

 


AHA Statement | Indications, evaluation, and outcomes for dual heart-kidney and heart-liver transplantation

14 Jul, 2023 | 12:51h | UTC

Dual-Organ Transplantation: Indications, Evaluation, and Outcomes for Heart-Kidney and Heart-Liver Transplantation: A Scientific Statement From the American Heart Association – Circulation

 


EASL Guidelines on the management of liver diseases in pregnancy

13 Jul, 2023 | 13:05h | UTC

EASL Clinical Practice Guidelines on the management of liver diseases in pregnancy – Journal of Hepatology

 


AASLD Guidance | Use of TIPS, variceal embolization, and retrograde transvenous obliteration in variceal hemorrhage

11 Jul, 2023 | 13:59h | UTC

AASLD Practice Guidance on the Use of TIPS, Variceal Embolization, and Retrograde Transvenous Obliteration in the Management of Variceal Hemorrhage – Hepatology

 


Guideline | Acute liver failure

10 Jul, 2023 | 13:59h | UTC

Acute Liver Failure Guidelines – The American Journal of Gastroenterology

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Guidelines for the management of adult acute and acute-on-chronic liver failure in the ICU

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Review | Acute-on-chronic liver failure

7 Jul, 2023 | 16:09h | UTC

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From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

30 Jun, 2023 | 15:01h | UTC

A multi-society Delphi consensus statement on new fatty liver disease nomenclature – Hepatology

 

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Phase 2 RCT | FGF21 analogue Pegozafermin treatment leads to improvement in NASH fibrosis

30 Jun, 2023 | 14:58h | UTC

Summary: In a phase 2b, multicenter, double-blind, randomized, placebo-controlled trial, the fibroblast growth factor 21 (FGF21) analogue pegozafermin was examined for its efficacy and safety in treating patients with biopsy-confirmed noncirrhotic nonalcoholic steatohepatitis (NASH). A total of 222 patients with moderate or severe fibrosis (stage F2 or F3) were assigned to receive either subcutaneous pegozafermin at varying doses or a placebo. The primary endpoints were an improvement in fibrosis and resolution of NASH without worsening of fibrosis at 24 weeks.

The results showed that a larger percentage of patients receiving pegozafermin met the criteria for fibrosis improvement and NASH resolution compared to those receiving placebo. The most significant improvements were observed in the 44-mg pegozafermin group, with 27% showing fibrosis improvement and 26% meeting NASH resolution criteria, compared to 7% and 2% in the placebo group, respectively. Adverse events were mainly gastrointestinal and included nausea and diarrhea. These findings support the progression of pegozafermin into phase 3 development.

Article: Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH – New England Journal of Medicine (link to abstract – $ for full-text)

 

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RCT | Bulevirtide reduces HDV RNA and ALT levels in chronic hepatitis D patients

28 Jun, 2023 | 13:20h | UTC

Summary: This randomized phase 3 trial evaluated the efficacy of bulevirtide, an inhibitor of HDV entry into hepatocytes, in patients with chronic hepatitis D. Patients were randomized to receive either 2 mg or 10 mg of bulevirtide daily for 144 weeks, or no treatment for 48 weeks followed by 10 mg bulevirtide daily for 96 weeks. The study involved 150 patients, 49 in the 2-mg group, 50 in the 10-mg group, and 51 in the control group.

After 48 weeks of treatment, 45% and 48% of patients in the 2-mg and 10-mg groups respectively achieved the primary end point of undetectable HDV RNA level or a decrease of at least 2 log10 IU per milliliter from baseline, and normalization of ALT level. Only 2% in the control group reached the primary endpoint. ALT levels normalized in 51% and 56% of patients in the 2-mg and 10-mg groups respectively, a significant difference from the 12% normalization in the control group. Notably, loss of HBsAg did not occur by week 48 in the bulevirtide groups. No serious adverse events related to the treatment were reported, though side effects including headache, pruritus, and fatigue were more common in the bulevirtide groups.

These results demonstrate the effectiveness of bulevirtide in reducing HDV RNA and ALT levels in patients with chronic hepatitis D. However, the absence of HBsAg loss in bulevirtide groups raises questions about its long-term implications.

Article: A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 


EASL Clinical Practice Guidelines on acute-on-chronic liver failure

27 Jun, 2023 | 14:00h | UTC

EASL Clinical Practice Guidelines on acute-on-chronic liver failure – Journal of Hepatology

 

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Cohort Study | Alcohol consumption and risks of more than 200 diseases in Chinese men

16 Jun, 2023 | 13:55h | UTC

Alcohol consumption and risks of more than 200 diseases in Chinese men – Nature Medicine

News Release: Alcohol consumption increases the risks of over 60 diseases – University of Oxford

 


M-A | Comparing non-invasive tests, histology for predicting non-alcoholic fatty liver outcomes

15 Jun, 2023 | 14:50h | UTC

Performance of non-invasive tests and histology for the prediction of clinical outcomes in patients with non-alcoholic fatty liver disease: an individual participant data meta-analysis – The Lancet Gastroenterology & Hepatology

 


M-A | Significant non-alcoholic fatty liver disease prevalence in South Asia, many non-obese affected

6 Jun, 2023 | 14:00h | UTC

Prevalence and associated factors for non-alcoholic fatty liver disease among adults in the South Asian Region: a meta-analysis – The Lancet Regional Health – Southeast Asia

 


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