Browsing by Author "Huang, Daniel Q."

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    Clinical trial design, biomarkers and end points in metabolic and alcohol-related liver disease
    (2025) Díaz Piga, Luis Antonio; Thiele, Maja; Louvet, Alexandre; Lee, Brian P.; Ajmera, Veeral; Tavaglione, Federica; Hsu, Cynthia L.; Huang, Daniel Q.; Pose, Elisa; Bataller, Ramon; McClain, Craig; Mellinger, Jessica; Tincopa, Monica; Mitchell, Mack C.; Ratziu, Vlad; Rinella, Mary E.; Sarin, Shiv K.; Shah, Vijay H.; Szabo, Gyongyi; Wong, Vincent Wai-Sun; Bansal, Meena B.; Leggio, Lorenzo; Kamath, Patrick S.; Krag, Aleksander; Sanyal, Arun J.; Arrese, Marco; Arab Verdugo, Juan Pablo; Anstee, Quentin M.; Mathurin, Philippe; Loomba, Rohit
    Metabolic and alcohol-related liver disease (MetALD) is a newly defined entity within the spectrum of steatotic liver disease, characterized by the interplay of cardiometabolic risk factors and alcohol consumption. The evolving epidemiology and complex pathophysiology of MetALD present unique challenges and opportunities for clinical trial design. Inclusion criteria should require simultaneous evidence of metabolic dysfunction (at least two cardiometabolic features) and verified quantifiable alcohol exposure recorded over the preceding 3–6 months. Traditional histological end points are limited by invasiveness, sampling error and interpretative variability. Thus, imaging modalities, serum-based fibrosis biomarkers and quantitative measures of alcohol intake are gaining relevance as non-invasive, reproducible and patient-centric end points aiming to improve trial feasibility. Furthermore, incorporating alcohol biomarkers, stratifying patients by metabolic risk factor burden, and using adaptive designs of trials might enhance the precision and generalizability of MetALD clinical trials. Although uncertainties remain regarding optimal patient selection criteria, event rates and the dynamic interplay between metabolic dysfunction and alcohol intake, ongoing research efforts aim to refine diagnostic criteria, standardize methodologies and validate novel end points. These advances will ultimately accelerate drug development, improve trial efficiency and foster interventions to treat MetALD.
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    Global and regional burden of alcohol-associated liver disease and alcohol use disorder in the elderly
    (2024) Danpanichkul, Pojsakorn; Suparan, Kanokphong; Ng, Cheng Han; Dejvajara, Disatorn; Kongarin, Siwanart; Panpradist, Nuttada; Chaiyakunapruk, Nathorn; Muthiah, Mark D.; Chen, Vincent L.; Huang, Daniel Q.; Diaz, Luis Antonio; Noureddin, Mazen; Arab, Juan Pablo; Wijarnpreecha, Karn
    Background & Aims: Alcohol -associated liver diseases (ALDs) and alcohol use disorder (AUD) pose a global health risk. AUD is underrecognized in the elderly, and the burden of AUD complications, including ALD, may increase with aging populations and rising alcohol intake. However, there is a lack of epidemiological evidence on AUD and ALD in the elderly. Methods: Using the Global Burden of Disease Study 2019, we analyzed the prevalence, mortality, disability -adjusted life years (DALYs), age -standardized rates (ASRs), and temporal change from 2000 to 2019 of ALD and AUD in the overall population and the elderly (65-89 years). The findings were categorized by sex, region, nation, and sociodemographic index. Results: The prevalence rates of ALD in the elderly were higher than those in adolescents and young adults, whereas AUD levels were lower than those in adolescents and young adults. In 2019, there were 9.39 million cases (8.69% of cases in the overall population) of AUD, 3.23 million cases (21.8% of cases in the overall population) of alcohol -associated cirrhosis, and 68,468 cases (51.27% of cases in the overall population) of liver cancer from alcohol among the elderly. ASRs of the prevalence of ALD and AUD in the elderly increased in most regions; on the contrary, ASRs of death and DALYs decreased in most regions. Nevertheless, ASRs of death and DALYs from liver cancer from alcohol increased in many areas. Conclusions: Our findings highlighted the increased prevalence of ALD in the elderly, with a burden of AUD comparable with that in the overall population. Public health strategies on ALD and AUD targeting the elderly are urgently needed. Impact and implications: The burden of alcohol -associated liver disease (ALD) and alcohol use disorder (AUD) is increasing. Advances in healthcare and education have resulted in a remarkable spike in life expectancy and a consequential population aging. Nevertheless, little is known about the epidemiology of ALD and AUD in the elderly. Our study indicates the increasing burden of ALD and AUD in the elderly population, necessitating early detection, intervention, and tailored care to the unique needs and complexities faced by older individuals grappling with these conditions. (c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association for the Study of the Liver (EASL). This is an open access article under the CC BY -NC -ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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    Incidence of liver cancer in young adults according to the Global Burden of Disease database 2019
    (2024) Danpanichkul, Pojsakorn; Aboona, Majd B.; Sukphutanan, Banthoon; Kongarin, Siwanart; Duangsonk, Kwanjit; Ng, Cheng Han; Muthiah, Mark D.; Huang, Daniel Q.; Seko, Yuya; Diaz Piga, Luis Antonio; Arab Verdugo, Juan Pablo; Yang, Ju Dong; Chen, Vincent L.; Kim, Donghee; Noureddin, Mazen; Liangpunsakul, Suthat; Wijarnpreecha, Karn
    Background and Aims: The worldwide burden of cancer is increasing in younger populations. However, the epidemiology of primary liver cancer remains understudied in young adults compared to other cancer forms., Approach and Results: This study analyzed data from the Global Burden of Disease study between 2010 and 2019 to assess the age-standardized incidence, mortality, and disability-adjusted life years associated with primary liver cancer in the young (15-49 y), stratified by region, nation, sociodemographic index, and sex. The study found a global estimate of 78,299 primary liver cancer cases, 60,602 deaths, and 2.90 million disability-adjusted life years in the young population. The Western Pacific region exhibited the highest burden in 2019, showing the most significant increase compared to other regions between 2010 and 2019. More than half of the countries worldwide have undergone an increase in primary liver cancer incidence rates in young adults. Around 12.51% of deaths due to primary liver cancer occur in young individuals. Throughout the study period, there was a significant decline in primary liver cancer mortality due to most etiologies, except for metabolic dysfunction-associated steatotic liver disease-attributable primary liver cancer (annual percentage change + 0.87%, 95% CI: 0.70%-1.05%) and alcohol-attributable primary liver cancer (annual percentage change + 0.21%, 95% CI: 0.01%-0.42%). The limitations of the Global Burden of Disease database include reliance on the quality of primary data and possible underestimation of alcohol consumption., Conclusions: Over the past decade, there has been a marked increase in the burden of primary liver cancer, especially that originating from steatotic liver disease. This trend calls for the development of urgent and comprehensive strategies to mitigate this rising burden globally.
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    Inherited Genetic Risk of Liver Fibrosis in Lean Versus Nonlean Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD)
    (John Wiley & Sons Ltd., 2025) Tesfai, Kaleb; Díaz Piga, Luis Antonio; Arab, Juan Pablo; Arrese, Marco; Idalsoaga, Francisco; Ayares, Gustavo; Agrawal, Saaket; Barreyro, Fernando Javier; Gadano, Adrian; Marciano, Sebastián; Martínez Morales, Jorge; Villela‐Nogueira, Cristiane; Leite, Nathalie; Salles, Gil; Regina Cardoso, Claudia; Alves Couto, Claudia; Theodoro, Rafael; Monteiro. Mísia Joyner de Sousa Dias; Oliveira, Claudia P.; Pessoa, Mario G.; Alvares‐da‐Silva, Mario Reis; Huang, Daniel Q.; Madamba, Egbert; Singh, Seema; Lokanadham, Snigdha; Bettencourt, Ricki; Richards, Lisa M.; Khera, Amit V.; Loomba, Rohit; Ajmera, Veeral
    Introduction Previous studies have revealed conflicting results regarding liver fibrosis risk in lean metabolic dysfunction–associated steatotic liver disease (MASLD). We aimed to compare the risk of significant fibrosis in lean versus nonlean MASLD and identify fibrosis-associated factors in lean MASLD. Methods The study was a cross-sectional analysis of prospectively enrolled adults with MASLD. Individuals with lean MASLD were age- and sex-matched with nonlean MASLD. Fibrosis assessment included vibration-controlled transient elastography, magnetic resonance elastography and liver biopsy. A genetic risk score (GRS), summating the effect alleles of PNPLA3 and TM6SF2 minus the protective HSD17B13 genotype, was estimated to consider inherited genetic risk across BMI categories. Results were validated in an external Latin American cohort.ResultsThe mean ( SD) age of 312 included participants with MASLD was 58.3  11.6 years and 69.2% were female. 44 (14.1%) individuals were lean, 90 (28.9%) were overweight, 90 (28.9%) had class I obesity and 88 (28.1%) had class II or greater obesity. The prevalence of significant fibrosis was 27.3% in lean and 31.1% in nonlean (p = 0.653). Individuals with a high GRS had a higher prevalence of significant fibrosis compared to patients with low GRS (36.5% vs. 25.2%, p = 0.043) and the prevalence of significant fibrosis was similar in lean and nonlean patients with high GRS (31.3% vs. 37.1%, p = 0.645). The Latin American cohort exhibited similar results. Conclusions The prevalence of significant fibrosis and the effect of GRS were similar in lean and nonlean MASLD, highlighting that lean MASLD patients may have a comparable risk to overweight and obese MASLD.
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    Socio-economic association of alcohol use disorder and cardiovascular and alcohol-associated liver disease from 2010 to 2019
    (2024) Danpanichkul, Pojsakorn; Chen, Vincent L.; Chaiyakunapruk, Nathorn; Auttapracha, Thanida; Kongarin, Siwanart; Ng, Cheng Han; Duangsonk, Kwanjit; Muthiah, Mark D.; Sukphutanan, Banthoon; Sim, Benedix; Huang, Daniel Q.; Seko, Yuya; Lee, Brian P.; Takahashi, Hirokazu; Noureddin, Mazen; Lazarus, Jeffrey V.; Diaz, Luis Antonio; Arab, Juan Pablo; Mellinger, Jessica Leigh; Liangpunsakul, Suthat; Wijarnpreecha, Karn
    Backgrounds and AimsAlcohol use leads to disabilities and deaths worldwide. It not only harms the liver but also causes alcohol use disorder (AUD) and heart disease. Additionally, alcohol consumption contributes to health disparities among different socio-economic groups.MethodsWe estimated global and regional trends in the burden of AUD, liver disease, and cardiovascular disease from alcohol using the methodology of the Global Burden of Disease study.ResultsIn 2019, the highest disability-adjusted life years rate per 100,000 population was due to AUD (207.31 [95% Uncertainty interval (UI) 163.71-261.66]), followed by alcohol-associated liver disease (ALD) (133.31 [95% UI 112.68-156.17]). The prevalence rate decreased for AUD (APC [annual percentage change] -0.38%) and alcohol-induced cardiomyopathy (APC -1.85%) but increased for ALD (APC 0.44%) and liver cancer (APC 0.53%). Although the mortality rate for liver cancer from alcohol increased (APC 0.30%), mortality rates from other diseases decreased. Between 2010 and 2019, the burden of alcohol-associated complications increased in countries with low and low-middle sociodemographic index (SDI), contributing more significantly to the global burden.ConclusionThe global burden of AUD, liver, and cardiovascular disease has been high and increasing over the past decade, particularly for liver complications. Lower SDI countries are contributing more to this global burden. There is a pressing need for effective strategies to address this escalating burden.