NAFLD: US GUIDELINES. US Guidelines for NAFLD

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1 NAFLD: US GUIDELINES Arun J Sanyal M.D. Charles Caravati Professor of Medicine Virginia Commonwealth University School of Medicine US Guidelines for NAFLD Represents consensus amongst AGA, AASLD and ACG Intended for health care professionals General guidance on approach and best practices using evidence-based medicine Care must still be individualized 1

2 Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Strength of recommendation: strong (1): quality of evidence and outcomes weak (2): more uncertainty in data, more resource utilization Quality of evidence: high (A): additional studies unlikely to change conclusions moderate (B): more research may modify conclusions low (C): more research highly likely to alter conclusions Nomenclature Nonalcoholic li fatty liver disease Nonalcoholic fatty liver 2-5% Nonalcoholic steatohepatitis 15-20% NASH cirrhosis Cryptogenic cirrhosis 2

3 The NAFLD Activity Score defines disease activity and can not be used to define NASH Kleiner et al, Hepatology, 2005 Failure of practice guidelines to recognize a large proportion of subjects TRIGGER: INSULIN RESISTANCE ALCOHOL PURE NASH MIXED DISEASE PURE ASH DISEASE PHENOTYPE 3

4 Proposed system of categorization (proposed only by author not by AASLD) Phenotype Disease activity Stage of Etiologies fibrosis Fatty liver NAFLD activity 1 score (NAS) Steatohepatitis Fat score Ballooning inflammation Insulin resistance Alcohol Hepatitis C Abetalipoproteinemia Drug-induced Post-JI bypass Lipodystrophy Wilson disease TPN US guidelines: screening Systematic screening of adults in primary care or diabetes or obesity clinics is not advised at this time due to the uncertainly surrounding diagnostic tests and treatment options along with lack of knowledge of long-term benefits and cost-effectiveness of screening. Strength= 1, Evidence= B 4

5 Non-invasive assessment of steatohepatitis and advanced fibrosis Metabolic syndrome predicts presence of steatohepatitis and may be used to target subjects for Bx (strength=1, evidence= B) NAFLD fibrosis score is a clinically useful tool to evaluate likelihood of having advanced fibrosis (strength= 1, evidence= B) CK 18 is promising but not ready for prime-time (strength= 1, evidence= B) The severity of NAFLD is associated with the severity of the metabolic syndrome 75 % with NASH neither HTN DM DM+HTN Features of metabolic syndrome Dixon et al, Gastroenterology, 2001; 121:

6 FIB4: a non-invasive way to detect advanced fibrosis age (yr) AST (IU/L)/(platelet count (10 9 /L) ALT (IU/L)) Shah et al, Clin Gastroenterol Hepatol October; 7(10): FIB4 predicts liver-related outcomes B Q1 Q2 Q3 Event Free Q4 Liver-related outcome: Ascites and its complications (SBP/HRS) Encephalopathy Variceal bleed HCC Time (Days) Nguyen et al, DDW

7 Caspase-3 generated fragments are seen in NASH Weicocka et al, Hepatology, 2006, 44:27-33 CK-18 fragment: Diagnostic value for NASH Cutoff (u/l) sensitivity specificity Feldstein et al, Hepatology 2009;50:

8 When to obtain a biopsy Liver biopsy should be considered in subjects at higher risk of steatohepatitis and advanced fibrosis Presence of metabolic syndrome and NAFLD fibrosis score predict such parameters Liver biopsy should be considered when competing etiologies of chronic liver disease can not be excluded without a biopsy Strength= 1, Evidence= B for all How to decide when to do a liver Bx to establish cause of abnormal ALT ALT Rule out other causes of liver disease Causes found No causes found Metabolic syndrome present Consider Bx risks: FIB4, ELF, c fibroscan etc YES Will Bx change Rx NO BX Ramesh and Sanyal, J Hepatol, Feb 2005 Yes BX No Discuss risks/benefits Make patient aware of risks of not doing Bx 8

9 NAFLD Fibrosis score (NFS) predicts mortality Mortality # deaths risk P value Low NFS Intermediate NFS High NFS Reference Kim et al, Hepatology, 2013, 57: FIB4 and mortality age (yr) AST (IU/L)/(platelet count (10 9 /L) ALT (IU/L)) A Survival Q1 Q2 Q3 Q4 Time (Days) Nguyen et al, DDW

10 Management: lifestyle intervention Weight loss reduces steatosis achieved with a hypocaloric diet alone or with physical activity (strength=1, evidence= A) Loss of 3-5% of body weight is required to improve steatosis but greater weight loss (~10%) may be needed to improve necroinflammation (strength= 1, evidence= B) Exercise alone may reduce steatosis but its ability to improve other aspects of NAFLD is unclear (strength= 1, evidence=b) Loss of steatosis after weight reduction Zelber-Sagi 1.48 Peng et al, Cochrane Database Syst Rev Jun 15;(6):CD doi: / CD pub3. 10

11 Impact of weight loss and lifestyle modification in NASH pro portion (%) or lbs p< p< Δ NAS > 2 weight loss lifestyle intervention Standard n= 20 vs 11 Promrat et al, Hepatology, 2010, 51:121-9 Drinking and risks of liver diease 4 drinks/day 4 drinks/day Becker U, et al. Hepatology May;23(5):

12 Impact of modest alcohol consumption on NAFLD phenotype Parameter Non-drinkers Modest drinkers Odds Pvalue (%) (%) ratio Steatohepatitis None Borderline Definite Fibrosis < < Dunn et al, J Hepatol Aug;57(2): Risk of HCC in cirrhosis due to NASH vs HCV Risk factors Older age Alcohol consumption Ascha et al, Hepatology, 2010, Jan 27 Epub 12

13 Coffee and NASH NASH CRN data N=782 38% Caucasian Median BMI 33 kg/m2 Coffee was protective in those with lower HOMA-IR but not in those with high HOMa- IR Mechanism of action controversial Post-hoc associations do not prove causality Larger concern is high caffiene drinks in combination with alcohol in young adults More data needed Bambha et al, Abstract # 99, AASLD 2012 Drug Treatment of NASH Vitamin E (800 U/day) improves liver histology in non-diabetic adults with biopsy-proven NASH and should be considered as first line treament- Strength 1, evidence- B Pioglitazone may be used to treat NASH Strength-1, evidence= B Drugs that don t work: Metformin (Strength-1, th evidence-a) UDCA (Strength-1, evidence-b) 13

14 External valididity of efficacy of vitamin E Authors n Dose Comparators Histology Arendt IU/day Placebo Improved^ Sanyal IU/day Pioglitazone, Improved* placebo Lavine IU/day Metformin, Improved*** placebo Harrison IU/day Placebo Improved** Sanyal IU/day Vit E Improved* + pioglitazone Dufour IU/day UDCA+placebo, Improved* placebo ^ CT scan assessment of steatosis only * All histologic parameters excluding fibrosis ** fibrosis improvement *** steatohepatitis and ballooning Primary Outcome of PIVENS Vitamin E alone met the pre-specified primary endpoint Proport ion of subjects (% ) P< P< /84 NNT=4.4 16/83 26/80 NNT= 6.6 Vit E placebo Pio treatment groups Sanyal et al, NEJM, April 28,

15 Vitamin E increased resolution of NASH (from initial definite or borderline NASH) Vitamin E (n=43) Placebo (n=38) Metformin (n=39) Resolved (%) 58% 28% 41% P-value Lavine et al, JAMA 2011 Pathophysiology-based rationale for treatment strategies Insulin sensitizers CB1 antagonists PUFAs Anti-miR 34 JNK inhibitors ER stress Insulin resistance FFA + insulin+ cytokines Steatosis + metabolic dysregulation Inflammatory signaling Oxidative stress Stellate cell activation Mitochondrial injury Apoptosis Cell death TNF modulator FXR agonists ARBs Incretins PDE Vitamin E Silymarin betaine Multiple sources fibrosis 15

16 Bariatric surgery Foregut surgery in not contraindicated in eligible subjects for such surgery for obesity and its complications Strength- 1, evidence-a The best type of foregut surgery for NAFLD is not established although the best data available are for RYGB Strength-1, evidence-b It is premature to consider foregut surgery as a specific treatment of NASH Strength-1, evidence-b Operations for weight loss Vertical banded gastroplasty Proximal gastric bypass Adjustable band gastroplasty JI bypass Bilio-pancreatic diversion 40% worsening Of fibrosis (Kral et al) 16

17 Biggest GAP in US guidelines Increased cardiovascular outcomes in NAFLD 17

18 NAFLD and cardiovascular findings Increase in: endothelial dysfunction carotid intimal thickness angiographically demonstrable coronary plaques carotid plaques arterial stiffness silent ischemia on EKG Multiple sources 35 Statins are safe to use Strength-1, evidence-b N= Time (months) Athyros et al, Lancet Dec 4;376(9756):

19 Open questions and emerging trends Definitions and classification of fatty liver diseaseparticularly re etiology and staging Noninvasive markers: to identify those with fatty liver disease to identify those who are going to have an adverse outcome from fatty liver disease to identify how close they are to having a bad outcome Need point of care testing and assessment Therapeutics role of specific agents and interventions (who, when, how) Define heirarchy of therapeutic interventions Should be driven by effectiveness NOT efficacy THANK YOU FOR YOUR ATTENTION 19

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