NASH management conflicts with guidelines in real-world setting, study finds

Researchers sought to learn how patient characteristics vary by stages of liver scarring and how U.S. physicians manage nonalcoholic steatohepatitis (NASH).

Physicians poorly adhered to guidelines on the diagnosis and management of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in a recent industry-funded study drawn from a variety of practice settings.

To identify trends in diagnosing and treating NASH, researchers conducted a cross-sectional observational study from a database of medical chart audits provided by U.S. physicians in 2016 (n=174) and 2017 (n=164). The database included more than 2,000 patients with NASH cared for by 170 physicians in multiple specialties who each treated more than 20 patients with NASH per month. Novo Nordisk Inc. funded the study, which was coauthored by three employees of the company. Results were published May 19 by BMC Gastroenterology.

Of 2,366 patients, 68% had stage F0 to F2 fibrosis, 21% had bridging fibrosis (F3), and 9% had cirrhosis (F4). Common comorbidities were type 2 diabetes (56%), hyperlipidemia (44%), hypertension (46%), and obesity (42%). Patients with more advanced fibrosis scores (F3-F4) were more likely to have these diseases than patients with less severe disease (F0-F2).

Diagnostic tests for NASH included ultrasound (80%), liver biopsy (78%), aspartate aminotransferase/alanine aminotransferase ratio (43%), NAFLD fibrosis score (25%), transient elastography (23%), NAFLD liver fat score (22%), and Fatty Liver Index (19%). Patients with NASH were prescribed vitamin E (53%), statins (51%), metformin (47%), angiotensin-converting enzyme inhibitors (28%), and beta-blockers (22%). Physicians commonly prescribed medications for reasons other than their known effects, the authors noted.

The researchers noted that more than 70% of patients received a liver biopsy, a higher proportion than reported in other real-world settings, and noted that the physicians in this study might be more comfortable using biopsy. That hepatologists and gastroenterologists performed fewer biopsies in patients with cirrhosis (F4 fibrosis) than in patients with F0-F3 fibrosis may reflect more experience in interpreting noninvasive tests, such as imaging, the researchers said.

The drug therapies prescribed were “particularly striking,” the authors wrote, since there are no FDA-approved treatments for NASH and that there is limited evidence on appropriate treatments for patients with varying degrees of NASH severity or liver fibrosis. Management of NASH relies on general lifestyle improvements and treatment of comorbidities, the authors noted. Of the most commonly prescribed treatments—vitamin E, statins, and metformin—only vitamin E has been shown to have any histological efficacy in randomized clinical trials.

“Interestingly, the primary reason physicians in this study said they prescribed [glucagon-like peptide-1 receptor agonists], [sodium-glucose cotransporter-2] inhibitors, and pioglitazone was to assist with weight loss; improvement or reversal of steatosis was the second most common reason. Weight loss may be perceived to be a cornerstone of NASH management,” the authors wrote.