Resolution of NASH improved HDL, triglycerides

BOSTON — New data from the PIVENS trial demonstrate that resolution of nonalcoholic steatohepatitis was associated with improvements in HDL cholesterol and triglycerides, but did not impact non-HDL or LDL cholesterol.

“While nonalcoholic fatty liver disease and NASH are associated with increased cardiovascular disease risk, the impact of NASH resolution on this risk and dyslipidemia as a cardiovascular disease risk marker is unknown,” Kathleen E. Corey, MD, MPH, director of the Massachusetts General Hospital Fatty Liver Clinic and the Gastrointestinal Unit, said during a presentation at The Liver Meeting. “The aim of our study was to determine the relationship between the resolution of NASH and dyslipidemia as a strong cardiovascular disease risk factor.”

Kathleen E. Corey

In the NASH CRN PIVENS trial 222 individuals were randomized to daily pioglitazone (Actos, Takeda), vitamin E or placebo to compare changes in lipid levels between those who experienced resolution of NASH with those whose NASH was unresolved.

Dyslipidemia was frequent in the patient population. Sixty-three percent of patients had low HDL (<40 mg/dL men; <50 mg/dL women), 46% hypertriglyceridemia (≥150 mg/dL), 47% hypercholesterolemia (≥200 mg/dL), 25% triglyceride/HDL ratio >5, 16% high LDL (≥160 mg/dL) and 73% elevated non-HDL cholesterol (≥130 mg/dL).

Overall, 35% of patients achieved NASH resolution: 47% of patients assigned pioglitazone, 36% assigned vitamin E and 21% assigned placebo.

Compared with unresolved NASH, patients who experienced resolution of NASH had increased HDL (2.9 mg/dL vs. –2.5 mg/dL; P<.001), decreased triglycerides (–21.1 vs. –2.3 mg/dL; P=.03) and improved triglyceride/HDL ratio (–0.7 vs. 0.1; P=.003). LDL and non-HDL cholesterol decreased irrespective of NASH resolution. Changes in lipids did not vary across treatment groups.

“NASH resolution was associated with improvements in triglycerides, HDL, triglycerides/HDL ratio and Framingham risk score, but NASH resolution did not impact LDL, total cholesterol or non-HDL cholesterol, [which are] potent predictors of cardiovascular disease risk,” Corey said. “Individuals with NASH resolution may remain at an increased cardiovascular disease risk, and should be targeted for lipid management. The mechanism for this differential change in lipids warrants further evaluations." – by Adam Leitenberger

For more information:

Corey K. Abstract 56. Presented at: The Liver Meeting ; Nov. 7-11, 2014; Boston.

Disclosure: Corey reports serving on advisory committees/review panels for Gilead.