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Lovastatin Not Harmful to Patients With Liver Disease: Presented at DDW

By Bruce Sylvester

LOS ANGELES, C.A. -- May 25, 2006 -- Lovastatin use does not appear to be harmful to patients with pre-existing liver disease, and even appears to improve some markers of liver function, researchers reported here at Digestive Diseases Week 2006 (DDW).

"The take-home message here is that use of lovastatin with these patients is not hepatotoxic, and can be used safely," said Andrew Avins, MD, research scientist, Northern California Kaiser Permanente Division of Research, Oakland, California.

Dr. Avins noted that some clinical trials involving statins have shown evidence of liver-function test (LFT) abnormalities, leading to recommendations for widespread LFT monitoring of statin-treated patients and avoidance of statin use among patients with liver disease.

"But we don't know much about the effects of statins on patients with pre-existing liver disease, since they are usually excluded from clinical trials of statin therapies," said Dr. Avins. "We wanted to find out about these risks, since we need data to make any rational decisions about statin use with these patients. That was the purpose of this study, and we chose to study an older, less expensive statin: lovastatin."

The investigators of this retrospective study selected data from adult subjects enrolled in the Northern California Kaiser Permanente Medical Care Program from January 1994 through June 2004 who had at least 2 alanine aminotransferase (ALT) elevations 6 to 18 months apart, a medical-record diagnosis of liver disease, or chronic hepatitis B or C infection.

The investigators excluded persons who had used a statin medication within 1 year of study entry.

The study group consisted of 13,492 patients who had used lovastatin and 79,628 patients who had not used the drug during the study period.

The primary endpoint was defined as concurrent serum ALT more than 3 times the upper limit of normal, total bilirubin more than 2 times the upper limit of normal, and alkaline phosphatase less than 1.5 times the upper limit of normal (Hy's Rule).

Secondary endpoints included any ALT over 3 times the upper limit of normal, cirrhosis, and liver failure.

The investigators reported that exposure to lovastatin was associated with a 72% decrease in the risk of developing a Hy's Rule endpoint over the study period (Incidence Rate Ratio [IRR] =.29, 95% Confidence Interval [CI] =.12 -.55). They also noted that the results were similar when adjusted for age and gender.

The absolute risk for the Hy's Rule event was very low among the lovastatin-exposed group, with an incidence rate of 61.9 events per 100,000 patient years of exposure.

Lovastatin exposure was also associated with a significant reduction in the risk of any secondary outcome -- liver injury, cirrhosis, and liver failure (IRR =.48, 95% CI =.42 -.55). "This was a surprising and exciting outcome," said Dr. Avins.

"Rates of statin prescription were similar across subgroups defined by hierarchical categories of liver-disease certainty, suggesting that confounding by contraindication was not a likely explanation for these results," the authors noted.

Dr. Avins added, "Lovastatin is not hepatoxic but, rather, it appears [to be] protective of adverse liver outcomes in patients with prior disease. This remarkable finding needs further study and validation."

This study was funded by Merck and Co. Inc., Blue Bell, Pennsylvania.


[Presentation title: Lovastatin Is Not Hepatotoxic to Patients With Pre-Existing Liver Disease. Abstract 202]

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