Cirrhosis, either by clinical evidence or biopsy, was present in 14% of the entire cohort. The median AST was 41 IU/L (standard deviation [SD] = 22) and median ALT 56 IU/L (SD = 36). An elevated alkaline phosphatase level with normal aminotransferase levels defined by local laboratory reference
ranges was found in 4% and a positive AMA in 4% of patients. There was no association between an isolated alkaline phosphatase elevation and a positive AMA. Of those with a biopsy at any time, 54% had ≥34% steatosis, 47% had GSK1120212 ≥grade 2 lobular inflammation, 66% had ballooning, 57% met the criteria for “definite” NASH, and 31% had bridging hepatic fibrosis or cirrhosis. The major differences between those with contemporaneous liver biopsies and those without was the lower prevalence of diabetes and
hypertension, lower glucose, lower HDL cholesterol, higher triglycerides, and less advanced fibrosis in the contemporaneous biopsy group. The contemporaneous liver biopsy group included all of the PIVENS patients, who did not, by definition, have diabetes or cirrhosis. Interestingly, the prevalence of the metabolic syndrome as defined by the NCEP ATP-III criteria was similar in all groups despite the group differences in individual components that define the metabolic syndrome. Aminotransferase levels were also higher in the contemporaneous biopsy group, possibly selleckchem reflecting more patients with lower enzyme levels because Protein kinase N1 of “burnt out” NASH in the setting of advanced fibrosis in the other groups. Further analyses of the study cohort focused on the subgroup with contemporaneous
liver biopsies. Factors associated with definite NASH in patients with NAFLD and contemporaneous liver biopsies are shown in Table 2. Patients with NASH were more likely to be women, have diabetes, and meet the NCEP criteria for the metabolic syndrome; they also had significantly higher levels of AST, ALT, GGT, triglycerides, HbA1c, HOMA-IR, and lower levels of HDL cholesterol compared to those without definite NASH. Patients with NASH also had significantly more steatosis, lobular inflammation, ballooning, and fibrosis as well as higher NAFLD Activity Scores. Portal inflammation was more likely to be greater than mild in those with definite NASH. There were no differences between the two groups in age, BMI, waist circumference, acanthosis nigricans, or self-identified Hispanic ethnicity. Interestingly, autoantibodies were found more often in those without definite NASH compared to those with NASH. Overall, the same factors associated with definite NASH were also significantly associated with ballooning. This may reflect the dominant role that the presence of ballooning has in establishing a diagnosis of definite NASH. The value of using ALT levels to screen for NASH in patients with NAFLD was examined using three different cutoffs for the upper reference range.