Racial disparities in nonalcoholic fatty liver disease clinical trial enrollment: A systematic review and meta-analysis

Table 1 Summary of non-alcoholic fatty liver disease studies included in systematic review

Year	Author	Study design	NAFLD or NASH	How NAFLD defined (ultrasound/biopsy)	Intervention	Total enrolled	% Men	Median age (yr)	Reporting of Race	Reporting of ethnicity	% White	% Black	% Hispanic	% Asian	% Other	Unknown
2005	Huang et al	Uncontrolled, open-label trial	NASH	Biopsy	Dietary intervention/ counseling	23	47.8	48	N	Y	87%	0%	13%	0%	0%	0%
2005	Clark et al	Prospective cohort	NAFLD	Biopsy	Roux-en-Y	16	50.0	43	Y	N	88%	NR	NR	NR	NR	12%3
2006	Barker et al	Retrospective cohort	NASH	Biopsy	Roux-en-Y	19	10.5	49	N	N	NR	NR	NR	NR	NR	NR
2006	Browning et al	Prospective cohort	NAFLD	Imaging (MRI)2	Statins	268	44.0	54	Y	Y	38%	50%	10%	0%	2%	0%
2006	Belfort et al	RCT	NASH	Biopsy	Pioglitazone	47	44.7	51	N	N	NR	NR	NR	NR	NR	NR
2007	Balas et al	RCT	NASH	Biopsy	Pioglitazone	35	54.3	48	N	N	NR	NR	NR	NR	NR	NR
2007	Lutchman et al	Uncontrolled, open-label trial	NASH	Biopsy	Discontinuation of pioglitazone	13	54.0	41.5	Y	Y	84%	0%	8%	8%	0%	0%
2009	Loomba et al	Uncontrolled, open-label trial	NASH	Biopsy	Metformin	26	50.0	44	Y	Y	65%	0%	15%	19%	0%	0%
2010	Chalasani et al	RCT	NASH	Biopsy	Pioglitazone/ Vitamin E	247	40.0	46	Y	Y	NR	NR	15%	NR	NR	85%4
2011	Foster et al	RCT	NAFLD	CT	Atorvastatin	80	71.0, 77.5 with NAFLD	59	Y	Y	93%	2%	2%	2%	0.5%	0%
2011	Van Wagner et al	RCT	NASH	Biopsy	Pentoxyfylline	30	43.3	50.5	Y	Y	80%	0%	17%	3%	0%	0%
2011	Zein et al	RCT	NASH	Biopsy	Pentoxyfylline	55	69.1	50	Y	N	93%	NR	NR	NR	NR	7%3
2011	Torres et al	RCT	NASH	Biopsy	Rosiglitazone/ metformin	108	50.4	49	Y	Y	65%	4%	22%		4%	5%
2012	Le et al	RCT	NASH	MRI	Colesevelam	50	46.0	47	Y	Y	38	0%	28%	22	8	0%
2012	Zein et al	RCT	NASH	Biopsy	Pentoxyfylline	47	70.2	50	Y	N	92%	NR	NR	NR	NR	8%3
2012	Sullivan et al	RCT	NAFLD	Biopsy	Exercise	18	27.8	48	N	N	NR	NR	NR	NR	NR	NR
2012	Fealy et al	RCT	NAFLD	Imaging (MRI)	Exercise	13	NR	58	N	N	NR	NR	NR	NR	NR	NR
2013	Mudaliar et al	RCT	NAFLD	Biopsy	Obeticholic acid	64	51.6	52	Y	Y1	42%	28%	25%	5%	0%	0%
2013	Beaton et al	Uncontrolled, open-label trial	NAFLD or NASH	Biopsy	Phlebotomy	31	61.3	49	N	N	NR	NR	NR	NR	NR	NR
2014	Sanyal et al	RCT	NASH	Biopsy	EPA-E	243	39.1	48	Y	N	91%	3%	0%	0%	6%	0%
2015	Dasarthy et al	RCT	NASH	Biopsy	Omega 3 fatty acids	37	21.6	50	Y	Y	92%	3%	5%	0%	0%	0%
2015	Argo et al	RCT	NASH	Biopsy	N-3 fish oil	34	38.2	46	Y	N	97%	NR	NR	NR	NR	3%3
2015	Loomba et al	RCT	NASH	Biopsy	Ezetemibe	50	38.0	49	Y	Y	NR	NR	34%	NR	NR	66%4
2015	Neuschwander et al	RCT	NAFLD	Biopsy	Obeticholic acid	283	33.9	51	Y	Y	83%	2%	15%	6%	10%	0%
2015	Vilar-Gomez et al	Prospective cohort	NASH	Biopsy	Bariatric surgery	293	41.0	48	Y	N	98%	NR	NR	NR	NR	2%3
2015	Glass et al	Prospective cohort	NASH	Biopsy	Weight loss	45	28.9	46	N	N	NR	NR	NR	NR	NR	NR
2016	Harrison et al	RCT	NASH	Biopsy	GT020 (galectin 3 protein inhibitor)	31	54.8	54	N	NR	NR	NR	NR	NR	NR	NR
2016	Cusi et al	RCT	NASH	Biopsy	Pioglitazone	101	70.3	51	Y	Y	25%	NR	67%	NR	8%	0%
2016	Cui et al	RCT	NAFLD	MRI	Sitagliptin	84	41.7	53.5	N	Y	32%	NR	36%	NR	NR	NR
2016	Ratziu et al	RCT	NASH	Biopsy	Elafibranor (PPAR agonist)	274	55	52	Y	N	89%	NR	NR	NR	NR	NR
2017	Winn et al	RCT	NAFLD	MRI	Exercise	21	NR	46	N	N	NR	NR	NR	NR	NR	NR
2017	Joy et al	RCT	NASH	Biopsy	Sitagliptin	12	41.7	56	Y	N	92%	NR	NR	NR	NR	8.3%3
2017	Loomba et al	RCT	NASH	Biopsy	Selonsertib (ASK1 inhibitor)	72	31	54.2	Y	N	90%	NR	NR	NR	NR	10%3
2017	Lawitz et al	Prospective cohort	NAFLD	MRI	Acetyl-CoA carboxylase inhibitor (GS-0976)	20	55	45	Y	N	100%	0%	NR	0%	0%	NR
2018	Shiffman et al	RCT	NAFLD	Biopsy or MRI	Emricasan	38	63.2	NR	Y	N	89%	NR	NR	NR	NR	11%3
2018	Schwenger et al	Prospective cohort	NAFLD	Biopsy	Bariatric surgery	42	23.8	48	N	N	NR	NR	NR	NR	NR	NR
2018	Chalasani et al	RCT	NAFLD	MRI	Leucine/metformin/sildenafil	70	44.3	46	Y	Y	63%	4.2%	27%	2.9%	1.4%	2.9%
2019	Harrison et al	Prospective cohort	NASH	Biopsy	FGF19 analog (NGM282)	43	20.9	50	N	Y	NR	NR	76.7%	NR	NR	23.34

¹Race and ethnicity categorized together.

²Definition of NAFLD included presence of steatosis on MRI.

³Patients were categorized as either white or non-white.

⁴Patients were categorized as either Hispanic or non-Hispanic. NAFLD: Non-alcoholic fatty liver disease; NASH: Non-alcoholic steatohepatitis; Y: Yes; N: No; MRI: Magnetic resonance imaging; NR: Not recorded; RCT: Randomized control trial.

Table 2 Proportion of trial patients with non-alcoholic steatohepatitis by race/ethnicity

	NASH
	Prevalence (%)	95%CI
Hispanic	24.7	9.1-40.4
White persons	63.9	42.4-85.5
Black persons	2.7	0.5-4.9

NASH: Non-alcoholic steatohepatitis; CI: Confidence interval.