Statins safe in NASH

Last Updated: 2017-06-16

By Marilynn Larkin

NEW YORK (Reuters Health) - Statin therapy is safe for diabetic and prediabetic individuals with nonalcoholic steatohepatitis (NASH), and should be encouraged, given these patients’ high risk of cardiovascular disease, researchers say.

Patients with NASH are often deprived of statin therapy due to fear of inducing liver toxicity, Dr. Kenneth Cusi of the University of Florida in Gainesville told Reuters Health. “(Our) study provides the first long-term prospective evidence that treatment with statins is safe in this population.”

Dr. Cusi and colleagues did a post-hoc analysis of statin use during a randomized, controlled trial assessing pioglitzone versus placebo, enrolling and following 101 patients with NASH plus prediabetes or type 2 diabetes for up to three years.

Only 38 patients (37%) were on statins at enrollment despite a high cardiovascular risk. The group receiving statins consisted mostly of men (82%).

Statin users and non-statin users were similar at baseline with respect to BMI, total body fat and presence of metabolic syndrome, the team reported in the Journal of Clinical Endocrinology and Metabolism, online June 1.

Statin users were slightly older (55 versus 48, p<0.001), and trended towards a higher prevalence of type 2 diabetes (63% versus 44%, p=0.07) compared with non-users. Statin users also had lower plasma levels of total cholesterol (166 versus 196 mg/dl, p<0.001) and low-density lipoprotein cholesterol (93 versus 119 mg/dl, p<0.001); however, the groups did not differ with respect to plasma triglyceride or high-density lipoprotein cholesterol concentration.

Non-statin users had higher plasma alanine transaminase levels but similar severity of liver disease at baseline. Four participants in both the statin and non-statin groups had at least a twofold increase in plasma aminotransferases during follow-up. One non-statin user did not continue in the study because of this elevation; values returned to normal without any active intervention in the other cases.

No changes in liver histology or hepatic insulin resistance were seen in those who were newly started on a statin compared with those receiving placebo during the main study.

Although the findings need to be confirmed in larger studies, Dr. Cusi said by email, “the take-home message is that primary care doctors, endocrinologists and hepatologists should be more proactive in prescribing statins, given their overall safety and the very high cardiovascular risk of patients with NASH.”

Dr. Gregg Fonarow, co-chief of the University of California, Los Angeles Division of Cardiology, told Reuters Health, “There have been concerns regarding the liver safety of statin medications in patients with NASH. This new analysis finds no evidence of worsening in liver function with the use of statin and some studies have even suggested improved liver function.”

“These findings further reinforce the liver safety of statin medications in a variety of clinical conditions,” he concluded. “For most patients, the proven benefits of statins outweigh any potential risks.”

SOURCE: http://bit.ly/2sjpfkH

J Clin Endocrinol Metab 2017.