Pentoxifylline for the treatment of non-alcoholic steatohepatitis: a randomized controlled trial

Wagner, Lisa B. Van; Koppe, Sean; Brunt, Elizabeth M.; Gottstein, Jeanne; Gardikiotes, Konstantina; Green, Richard M.; Rinella, Mary E.

doi:10.1016/s1665-2681(19)31539-x

Cited by 159 publications

(100 citation statements)

References 25 publications

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“…A randomized placebo controlled trial by Zein et al [53] showed that pentoxifylline 400 mg 3 times a day over 1 year improved steatosis and lobular inflammation with no significant effect on ballooning degeneration [53] . However, in a similar study done by Van Wagner et al [54] , pentoxifylline improved transaminases, hepatic steatosis and ballooning degeneration when compared to baseline but when compared to placebo, the improvement was not clinically significant. Pentoxifylline did not improve any metabolic marker of insulin resistance.…”

Section: Pentoxifyllinementioning

confidence: 70%

Non-alcoholic fatty liver disease in 2015

Ahmed¹

2015

WJH

174

134

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There is worldwide epidemic of non-alcoholic fatty liver disease (NAFLD). NAFLD is a clinical entity related to metabolic syndrome. Majority of the patients are obese but the disease can affect non-obese individuals as well. Metabolic factors and genetics play important roles in the pathogenesis of this disorder. The spectrum of disorders included in NAFLD are benign macrovesicular hepatic steatosis, non-alcoholic steatohepatitis, hepatic fibrosis, cirrhosis of liver and hepatocellular carcinoma. Although the disease remains asymptomatic most of the time, it can slowly progress to end stage liver disease. It will be the most common indication of liver transplantation in the future. It is diagnosed by abnormal liver chemistry, imaging studies and liver biopsy. As there are risks of potential complications during liver biopsy, many patients do not opt for liver biopsy. There are some noninvasive scoring systems to find out whether patients have advanced hepatic fibrosis. At the present time, there are limited treatment options which include lifestyle modification to loose weight, vitamin E and thioglitazones. Different therapeutic agents are being investigated for optimal management of this entity. There are some studies done on incretin based therapies in patients with NAFLD. Other potential agents will be silent information regulator protein Sirtuin and antifibrotic monoclonal antibody Simtuzumab against lysyl oxidase like molecule 2. But they are still in the investigational phase.

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Section: Pentoxifyllinementioning

confidence: 70%

Non-alcoholic fatty liver disease in 2015

Ahmed¹

2015

WJH

174

134

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“…29, 30 Two RCTs provided data on overall FPR but not by baseline stage. 31, 32 Two RCTs reported the proportion of placebo-treated patients who progressed or remained stable, but no additional information to estimate FPR. 33, 34 Overall, these RCTs reported on 186 patients treated with placebo (158 with paired biopsies), of whom 38 (24.0%) had worsening fibrosis, 84 (53.2%) remained stable and 36 (22.8%) had improvement in fibrosis stage on follow-up biopsy (Supplementary Table 1 and 2); due to limited number of studies with short duration of follow-up, an accurate estimate of FPR could not be obtained.…”

Section: Resultsmentioning

confidence: 99%

Fibrosis Progression in Nonalcoholic Fatty Liver vs Nonalcoholic Steatohepatitis: A Systematic Review and Meta-analysis of Paired-Biopsy Studies

Singh

Allen

Wang

et al. 2015

Clinical Gastroenterology and Hepatology

1,416

1,136

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Background & Aims Little is known about differences in rates of fibrosis progression between patients with nonalcoholic fatty liver (NAFL) vs nonalcoholic steatohepatitis (NASH). We conducted a systematic review and meta-analysis of all studies that assessed paired liver biopsies to estimate the rates of fibrosis progression in patients with NAFLD including NAFL and NASH. Methods Through a systematic search of multiple databases and author contact, up to June 2013, we identified studies of adults with NAFLD that collected paired liver biopsies at least 1 year apart. From these, we calculated a pooled-weighted annual fibrosis progression rate (number of stages changed between the 2 biopsy samples) with 95% confidence intervals (CI), and identified clinical risk factors associated with progression. Results We identified 11 cohort studies including 411 patients with biopsy-proven NAFLD (150 with NAFL and 261 with NASH). At baseline, the distribution of fibrosis for stages 0, 1, 2, 3, and 4 was 35.8%, 32.5%, 16.7%, 9.3%, and 5.7%, respectively. Over 2145.5 person-years of follow up, 33.6% had fibrosis progression, 43.1% had stable fibrosis, and 22.3% had improvement in fibrosis stage. The annual fibrosis progression rate in patients with NAFL who had stage 0 fibrosis at baseline was 0.07 stages (95% CI, 0.02–0.11 stages), compared with 0.14 stages in patients with NASH (95% CI, 0.07-0.21 stages). These findings correspond to 1 stage of progression over14.3 years for patients with NAFL (95% CI, 9.1–50.0 years) and 7.1 years for patients with NASH (95% CI, 4.8–14.3 years). Conclusions Based a meta-analysis of studies of paired liver biopsy studies, liver fibrosis progresses in patients with NAFL and NASH.

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“…Only two RCTs to date have investigated histologic end points of treatment. 104, 105 Zein et al conducted a placebocontrolled trial including 55 patients with biopsy-proven NASH who were randomized to either PTX 400 mg three times daily orally or placebo for 12 months. 105 Liver histology was assessed at the end of the treatment.…”

Section: Emerging Therapiesmentioning

confidence: 99%

“…A smaller RCT including 26 patients who were randomized to either PTX or placebo did not show improvement in histology or ALT. 104 Although the dosing and treatment duration were the same as the other RCT, this study included patients with cirrhosis, which may account for some of the differences in outcomes. Nausea and vomiting were the most common side effects in those receiving PTX.…”

Section: Emerging Therapiesmentioning

confidence: 99%

Recommendations for Diagnosis, Referral for Liver Biopsy, and Treatment of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis

Spengler

Loomba

2015

Mayo Clinic Proceedings

225

180

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Nonalcoholic fatty livery disease (NAFLD) is the primary cause of chronic liver disease in the United States, afflicting an estimated 80–100 million Americans. NAFLD is a spectrum of liver diseases comprised of nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH). Whereas NAFL has negligible risk of progression, NASH patients often develop cirrhosis or hepatocellular carcinoma. Although liver biopsy is required to diagnose NASH, only patients with a high risk of NASH or advanced fibrosis require this evaluation. Despite the high prevalence of NAFLD, well-defined screening recommendations are currently lacking. In this review, suggestions for screening, diagnosis and initial work-up of NAFLD are given based on established guidelines and recent publications. Proposed drug treatments for NASH are also discussed, highlighting the study outcomes, as well as proposed uses and limitations of these drugs. PubMed was used with search terms nonalcoholic fatty liver disease and nonalcoholic steatohepatitis with filters of “English language.” A date range of January 1, 2000 to May 1, 2015 was used for the search. The bibliographies of key references were also manually searched and seminal publications before the year 2000 were included.

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Pentoxifylline for the treatment of non-alcoholic steatohepatitis: a randomized controlled trial

Cited by 159 publications

References 25 publications

Non-alcoholic fatty liver disease in 2015

Non-alcoholic fatty liver disease in 2015

Fibrosis Progression in Nonalcoholic Fatty Liver vs Nonalcoholic Steatohepatitis: A Systematic Review and Meta-analysis of Paired-Biopsy Studies

Recommendations for Diagnosis, Referral for Liver Biopsy, and Treatment of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis

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