Original Article
Hepatology
Clinical and Patient-Reported Outcomes From Patients With Nonalcoholic Fatty Liver Disease Across the World: Data From the Global Non-Alcoholic Steatohepatitis (NASH)/ Non-Alcoholic Fatty Liver Disease (NAFLD) Registry

https://doi.org/10.1016/j.cgh.2021.11.004Get rights and content

Background & Aims

Globally, nonalcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease. We assessed the clinical presentation and patient-reported outcomes (PROs) among NAFLD patients from different countries.

Methods

Clinical, laboratory, and PRO data (Chronic Liver Disease Questionnaire–nonalcoholic steatohepatitis [NASH], Functional Assessment of Chronic Illness Therapy–Fatigue, and the Work Productivity and Activity Index) were collected from NAFLD patients seen in real-world practices and enrolled in the Global NAFLD/NASH Registry encompassing 18 countries in 6 global burden of disease super-regions.

Results

Across the global burden of disease super-regions, NAFLD patients (n = 5691) were oldest in Latin America and Eastern Europe and youngest in South Asia. Most men were enrolled at the Southeast and South Asia sites. Latin America and South Asia had the highest employment rates (>60%). Rates of cirrhosis varied (12%–21%), and were highest in North Africa/Middle East and Eastern Europe. Rates of metabolic syndrome components varied: 20% to 25% in South Asia and 60% to 80% in Eastern Europe. Chronic Liver Disease Questionnaire–NASH and Functional Assessment of Chronic Illness Therapy–Fatigue PRO scores were lower in NAFLD patients than general population norms (all P < .001). Across the super-regions, the lowest PRO scores were seen in Eastern Europe and North Africa/Middle East. In multivariate analysis adjusted for enrollment region, independent predictors of lower PRO scores included younger age, women, and nonhepatic comorbidities including fatigue (P < .01). Patients whose fatigue scores improved over time experienced a substantial PRO improvement. Nearly 8% of Global NAFLD/NASH Registry patients had a lean body mass index, with fewer metabolic syndrome components, fewer comorbidities, less cirrhosis, and significantly better PRO scores (P < .01).

Conclusions

NAFLD patients seen in real-world practices in different countries experience a high comorbidity burden and impaired quality of life. Future research using global data will enable more precise management and treatment strategies for these patients.

Section snippets

Study Population

In 2017, the GNR was created as a collaborative effort among investigators from more than 20 countries who were involved in the Global NASH Council. Each investigator who was willing to establish a GNR site within their country obtained an approval to enroll and obtain patient consent from their local Institutional Review Board or a similar supervisory institution. Per GNR protocol, patients seen in participating sites with an established diagnosis of NAFLD by a historic liver biopsy or imaging

Results

A total of 5691 NAFLD patients from GNR were included in this analysis. Subjects were enrolled from 23 sites located in 18 countries (Australia, China, Cuba, Egypt, Greece, Hong Kong, India, Italy, Japan, Saudi Arabia, Malaysia, Mexico, Pakistan, Russia, Spain, Taiwan, Turkey, and the United States). According to GBD super-regions, 50% were enrolled at sites located in the high-income region, 22% in MENA, 14% in Southeast and East Asia, 7% in Latin America and the Caribbean, 4% from Eastern and

Discussion

This study, using data from a global NAFLD/NASH registry, provides a unique perspective about patients with NAFLD across different regions of the world. First, the data confirm that the majority of patients with NAFLD, regardless of their location, are obese and have multiple components of metabolic syndrome. This is consistent with reports from the GBD study that suggest that the global epidemic of NAFLD is driven primarily by increasing rates of obesity and type 2 diabetes.10,11

CRediT Authorship Contributions

Zobair M. Younossi, MD (Conceptualization: Lead; Project administration: Lead; Writing – original draft: Lead; Writing – review & editing: Equal)

Yusuf Yilmaz (Data curation: Equal; Supervision: Equal; Writing – review & editing: Equal)

Ming-Lung Yu (Data curation: Equal; Supervision: Equal; Writing – review & editing: Equal)

Vincent Wai-Sun Wong (Data curation: Equal; Supervision: Equal; Writing – review & editing: Equal)

Marlen Castellanos Fernandez (Data curation: Equal; Supervision: Equal;

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    Conflicts of interest The authors disclose no conflicts.

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