Dataset Information

Race/ethnic and sex disparities in the non-alcoholic fatty liver disease-abdominal aortic calcification association: The Multi-Ethnic Study of Atherosclerosis.

ABSTRACT: This study investigated the associations of non-alcoholic fatty liver disease (NAFLD) and abdominal aortic calcification (AAC) volume and density, and whether these relationships vary by race/ethnicity and/or sex, information that are limited in current literature.We studied 1004 adults from the Multi-Ethnic Study of Atherosclerosis to assess the relationship between NAFLD (liver-to-spleen ratio <1) and the following measures of AAC: presence (volume score >0, using Poisson regression); change in volume score (increasing vs. no change, using Poisson regression); and morphology (volume and density score, where volume score >0, using linear regression); and interaction by race/ethnicity and sex.Among Blacks, those with NAFLD had greater prevalence for AAC compared to Whites regardless of sex (Prevalence Ratio [PR] = 1.41, CI = 1.15-1.74, p-interaction = 0.02). Concurrent interaction by race/ethnicity and sex was found comparing Chinese and Blacks to Whites (p-interaction = 0.017 and 0.042, respectively) in the association between NAFLD and the prevalence of increasing AAC. Among women, this relationship was inverse among Chinese (PR = 0.59, CI = 0.28-1.27), and positive among Whites (PR = 1.34, CI = 1.02-1.76). This finding was reversed evaluating the men counterpart. Black men also had a positive association (PR = 1.86, CI = 1.29-2.70), which differed from the inverse relationship among White men, and was greater compared to Black women (PR = 1.45, CI = 1.09-1.94). NAFLD was unrelated to AAC morphology.NAFLD was related to the presence of AAC, however, limited to Blacks. Significant concurrent interaction by race/ethnicity (Chinese and Blacks vs. Whites) and sex was found in the relationship between NAFLD and increasing AAC. These findings suggest disparities in the pathophysiologic pathways in which atherosclerosis develops.

SUBMITTER: Remigio-Baker RA

PROVIDER: S-EPMC5502083 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Race/ethnic and sex disparities in the non-alcoholic fatty liver disease-abdominal aortic calcification association: The Multi-Ethnic Study of Atherosclerosis.

Remigio-Baker Rosemay A RA Allison Matthew A MA Forbang Nketi I NI Loomba Rohit R Anderson Cheryl A M CAM Budoff Matthew M Schwimmer Jeffrey B JB Blumenthal Roger S RS Ouyang Pamela P Criqui Michael H MH

Atherosclerosis 20161117

<h4>Background and aims</h4>This study investigated the associations of non-alcoholic fatty liver disease (NAFLD) and abdominal aortic calcification (AAC) volume and density, and whether these relationships vary by race/ethnicity and/or sex, information that are limited in current literature.<h4>Methods</h4>We studied 1004 adults from the Multi-Ethnic Study of Atherosclerosis to assess the relationship between NAFLD (liver-to-spleen ratio <1) and the following measures of AAC: presence (volume s ...[more]

PMID: 28235711

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Project description:ObjectiveVulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States.MethodsWe queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups.ResultsThe FDA provided 29 approvals from 29 trials of 24 devices: 15 EVAR devices (52%), 12 TEVAR devices (41%), 1 FEVAR device (3.4%), and 1 dissection stent (3.4%). These trials had included 4046 patients. Of the 29 trials, all had reported on the sex of the participants, and the median female enrollment was 21% (interquartile range [IQR], 11%-34%). The EVAR trials had the lowest female enrollment (11%; IQR, 8.7%-13%) compared with 41% (IQR, 27%-45%) in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial (P < .01 for the difference). Only 52% of the trials had reported the three most common racial groups (White, Black, Asian), and only 48% had reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). Where reported, the median enrollment of racial and ethnic groups across the trials was as follows: Black patients, 9.8% (FEVAR, 0%; EVAR, 1.9%; TEVAR, 12%; dissection stent, 25%; P = .01); Asian patients, 2.4% (EVAR, 0.6%; FEVAR, 2.4%; TEVAR, 2.5%; dissection stent, 11%; P = .24); and Hispanic patients, 3.8% (EVAR, 1.3%; FEVAR, 2.4%; TEVAR, 3.9%; dissection stent, 4.1%; P = .75).ConclusionsRacial and ethnic minority groups were underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients were also underrepresented in these aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices and minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.

Dataset Information

Race/ethnic and sex disparities in the non-alcoholic fatty liver disease-abdominal aortic calcification association: The Multi-Ethnic Study of Atherosclerosis.

Publications

Race/ethnic and sex disparities in the non-alcoholic fatty liver disease-abdominal aortic calcification association: The Multi-Ethnic Study of Atherosclerosis.

Similar Datasets

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