Tuesday, May 22, 2012

DDW-Statins Shown to Be Safe in Patients With Cirrhosis

May 22, 2012
From Medscape Medical News

Statins Shown to Be Safe in Patients With Cirrhosis

Caroline HelwickSan Diego, California) — Statin therapy is not only safe for people with cirrhosis, it might be potentially beneficial, according to research presented here at Digestive Disease Week 2012.

"We found less progression of liver disease in patients taking statins, and a lower mortality rate. This is contrary to prior beliefs that statins may not be safe in patients with cirrhosis; in fact, they may be beneficial," said lead investigator Sonal Kumar, MD, from Brigham and Women's Hospital in Boston, Massachusetts.

Patients with cirrhosis have decreased hepatic clearance, and thus could be at increased risk for complications, specifically hepatic decompensation. Statins lower portal pressure and, therefore, might be protective of the liver, she explained.

Dr. Kumar and colleagues conducted a study to determine the effect of statin therapy on the risk from hepatic decompensation in 82 people with biopsy-proven cirrhosis who had taken statins for at least 3 months for the treatment of dyslipidemia. This group was compared with 162 control subjects who had cirrhosis but were not taking statins and who were matched in a 2:1 ratio by age, sex and Child-Pugh class.

In each group, 70.4% of patients were Child-Pugh A and 29.6% were Child-Pugh B/C. Other relevant disease-related factors were not different between the groups. Median duration of statin use was 25 months. Median follow-up was 36 months for the statin group and 30 months for the control group.

The primary outcomes were hepatic decompensation (defined as the development of ascites, jaundice, hepatic encephalopathy, or variceal hemorrhage) and time to decompensation.

Statins Cut Decompensating Events in Half

In a multivariate analysis, the use of a statin was associated with a 56% reduction in risk for hepatic decompensation (95% confidence interval [CI], 0.27 to 0.71). There were fewer decompensating events in the statin group than in the control group (39.5% vs 55.6%; P = .01), Dr. Kumar reported.

The largest difference was observed for patients who developed jaundice (7.4% vs 20.9%; P = .001) or ascites (20.9% vs 37.0%; P = .009).

Time to decompensation was significantly longer in the statin group. In the control group, half had decompensated at 2.3 years; in the statin group, median time to decompensation was not reached. In Child-Pugh A patients, median time to decompensation was 8.1 years in the control group; again, it was not reached in the statin group.

In addition, overall mortality was significantly lower in the statin group (37.0% vs 50.6%; P = .043). On multivariate analysis, statin use was significantly associated with a 51% reduction in mortality (95% CI, 0.29 to 0.81), Dr. Kumar reported.

Strikingly, in Child-Pugh A patients, time to death was significantly longer in the statin group than in the control group (7.0 vs 14.4 years; P = .005).

Although 29 patients in the control group underwent liver transplantation, only 2 patients in the statin group did, she added.

There were no differences in cause of death, although for one third of patients, cause of death could not be ascertained.

The study has a number of limitations, Dr. Kumar acknowledged. It is a retrospective study of a heterogeneous population with varied duration of statin therapy; compliance with statin use was not well documented; and investigators could not account for a number of potentially contributing factors, including obesity, use of aspirin or other nonsteroidal anti-inflammatory drugs, and active alcohol consumption.

Bruce Sands, MD, MS, the Dr. Burrill B. Crohn professor of medicine at Mount Sinai Medical Center in New York City, moderated a press briefing during which the results were discussed. "This is a wonderful study, but it is retrospective and hypothesis-generating. I would like to see a prospective randomized controlled trial showing there are actually benefits to statin use," he said.

Zobair Younossi, MD, vice president of research and chair of medicine at the Inova Health System in Falls Church, Virginia, explained that his own research has shown that disease-related mortality is similar among statin users and nonusers. "Statins are safe," he maintained. "Don't worry about further liver toxicity."

Dr. Kumar said that this information should be reassuring to physicians, many of whom discontinue statin use in their patients, which puts them at risk for worsening cardiovascular disease.

Dr. Kumar, Dr. Sands, and Dr. Younossi have disclosed no relevant financial relationships.

Digestive Disease Week (DDW) 2012: Abstract 595. Presented May 21, 2012.

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