Diagnostic value of biochemical markers (NashTest) for the prediction of non alcoholo steato hepatitis in patients with non-alcoholic fatty liver disease

Poynard, Thierry; Ratziu, Vlad; Charlotte, Frédéric; Messous, Djamila; Munteanu, Mona; Imbert‐Bismut, Françoise; Massard, Julien; Bonyhay, Luminita; Tahiri, Mohamed; Thabut, Dominique; Cadranel, J.F.; Bail, Brigitte Le; Lédinghen, Victor de

doi:10.1186/1471-230x-6-34

Cited by 264 publications

(180 citation statements)

References 49 publications

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“…Methods such as ranked assessment (classifying as better, worse, or unchanged), or a truly quantitative measurement of the area of fibrosis by micromorphometry could be useful especially in early phase trials. Importantly, biomarkers for each cardinal feature of steatohepatitis [56][57][58][59][60][61][62] need to be developed and validated for longitudinal changes on therapy.…”

Section: Lessons For the Design Of Future Clinical Trialsmentioning

confidence: 99%

Therapeutic trials in nonalcoholic steatohepatitis: Insulin sensitizers and related methodological issues

2010

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Insulin sensitizers are attractive candidate therapies for nonalcoholic steatohepatitis mainly because of the strong association between this disease and insulin resistance. This review provides a critical overview of the mechanisms of action, clinical trial results, and safety issues of metformin and glitazones in nonalcoholic steatohepatitis. It also highlights methodological challenges for trial design and proposes endpoints for future proof of principle, registrational, and postmarketing trials. (HEPATOLOGY 2010;52:2206-2215 N onalcoholic steatohepatitis (NASH) is emerging as the next big therapeutic challenge in hepatology. 1 Currently the top cause of newly identified chronic liver diseases, NASH has potential for fibrosis, cirrhosis decompensation, and hepatocellular carcinoma. Not all individuals with metabolic risk factors will experience these adverse outcomes and identifying those at risk is critical. Prognostic markers for progression have mostly been derived from histological studies. Compared to steatosis alone or to steatosis and minimal inflammation, the coexistence of inflammation, cell injury (ballooning), and steatosis, a pathological aggregate labeled steatohepatitis, is associated with a significant increase in overall mortality and in liver-related mortality. The degree of inflammation is the best predictor of fibrosis progression, 2 a widely accepted surrogate for hard endpoints such as cirrhosis, endstage liver disease, and possibly hepatocellular carcinoma.Insulin resistance (IR) is consistently found in patients with NASH in both cross-sectional and longitudinal studies. Moreover, there is a stepwise increase in the severity of IR and its phenotypic complications (clustered as elements of the metabolic syndrome) between normal liver, isolated steatosis, and steatohepatitis that has prompted speculation that IR might contribute to liver damage. Logically, most therapeutic trials focused on insulin sensitizers (IS) as candidate therapies.The aim of this report is to critically review the results of trials of metformin and glitazones for NASH. We highlight methodological challenges for trial design and propose endpoints for future proof of principle, registrational, and postmarketing trials.

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Section: Lessons For the Design Of Future Clinical Trialsmentioning

confidence: 99%

Therapeutic trials in nonalcoholic steatohepatitis: Insulin sensitizers and related methodological issues

2010

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“…Serologic markers that aimed to evaluate activity and fibrosis [6] and also steatosis [7] were developed (like FibroMax), followed by an ultrasound based method, Transient Elastography (TE), able to assess liver stiffness (LS) as a marker of fibrosis [8].…”

Section: Introductionmentioning

confidence: 99%

Comparison between the M and XL probes for liver fibrosis assessment by Transient Elastography

et al. 2014

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Objective: Liver stiffness measurement (LSM) using Transient Elastography (TE) for liver fibrosis assessment is difficult to be performed in obese and overweight patients by standard M probe, thus the XL probe was developed. The aim of our paper was to assess the usefulness of the XL probe in daily clinical practice. Material and method: Our study included 216 patients (mean BMI 30.1±4.1 kg/m2) with chronic hepatopathies, in which paired measurements were made using the M (3.5MHz) and XL (2.5 MHz) probes in the same session. In each patient 10 valid LSM were acquired with each probe, a median was calculated, expressed in kiloPascals (kPa). Unreliable TE measurements were considered: fewer than 10 valid shots; with a success rate (SR) <60% and/or interquartile range interval (IQR) ≥30%. Results: In 127 patients reliable LSM could not be obtained by standard M probe, 10 of them normal weight, 25 of them overweight, and 92 obese. By XL probe reliable measurements were obtained in 80/127(63%) of these patients: 8/10 (80%) of the normal weights, 17/25 (68%) of the overweight and 55/92 (59.8%) of the obese. In 98 patients with reliable M probe measurements, XL probe LSMs were also performed. XL LS values strongly and significantly correlated with those obtained by M probe (Spearman r=0.789, p<0.0001), but were significantly lower [median 6.4 kPa (range 3.1 -53.8) vs 7.7 kPa (range 3.7-69.1), Wilcoxon paired t test p<0.001)]. Conclusion: By using the XL probe, reliable LSM by TE can be obtained in more than 60% of patients with unreliable measurements by M probe. LSM by XL probe are significantly correlated, but lower, than those obtained by M probe.

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“…These biomarkers are commonly combined with clinical risk factors for hepatic fibrosis, such as age, obesity, or diabetes. [5][6][7][8][9][10][11][12] Recently, serological parameters reflecting insulin resistance, oxidative stress, or hormonal activity of visceral adipose tissue have attracted increasing attention. Several adipokines have been implicated in the pathogenesis of NASH and NAFLD.…”

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confidence: 99%

A composite model including visfatin, tissue polypeptide-specific antigen, hyaluronic acid , and hematological variables for the diagnosis of moderate-to-severe fibrosis in nonalcoholic fatty liver disease: a preliminary study

Chwist¹,

Hartleb²,

Lekstan³

et al. 2014

Polish Archives of Internal Medicine

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Diagnostic value of biochemical markers (NashTest) for the prediction of non alcoholo steato hepatitis in patients with non-alcoholic fatty liver disease

Abstract: Background: Liver biopsy is considered the gold standard for assessing histologic lesions of non-alcoholic fatty liver disease (NAFLD). The aim was to develop and validate a new biomarker of non alcoholic steato hepatitis (NASH) the NashTest (NT) in patients with NAFLD.

Cited by 264 publications

References 49 publications

Therapeutic trials in nonalcoholic steatohepatitis: Insulin sensitizers and related methodological issues

Therapeutic trials in nonalcoholic steatohepatitis: Insulin sensitizers and related methodological issues

Comparison between the M and XL probes for liver fibrosis assessment by Transient Elastography

A composite model including visfatin, tissue polypeptide-specific antigen, hyaluronic acid , and hematological variables for the diagnosis of moderate-to-severe fibrosis in nonalcoholic fatty liver disease: a preliminary study

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