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Rosiglitazone safe with some patients: study

Posted on: Tuesday, 12 July 2005, 12:44 CDT

By Megan Rauscher

NEW YORK (Reuters Health) - Diabetic patients with elevated baseline liver enzymes are not at increased risk of hepatotoxicity from treatment with the thiazolidinedione rosiglitazone, results of a study suggest. "Rosiglitazone can be safely used in diabetic patients with fatty liver disease," study leader Dr. Naga Chalasani told Reuters Health.

Although the second-generation thiazolidinediones -- rosiglitazone and pioglitazone -- are "generally very safe from a hepatic standpoint," isolated reports of hepatotoxicity have been reported, Dr. Chalasani, from Indiana University School of Medicine in Indianapolis, pointed out.

It is currently recommended that rosiglitazone be used cautiously in diabetics with mild elevations in liver enzymes and that it not be used in those with alanine aminotransferase greater than 2.5 the upper limit of normal, Dr. Chalasani and colleagues explain in the June issue of the American Journal of Gastroenterology.

However, they say, whether the risk of thiazolidinedione-related hepatotoxicity is higher in diabetics with elevated liver enzymes as opposed to normal liver enzymes has not been adequately studied.

Dr. Chalasani's team took a look back at the effect of rosiglitazone on serum liver biochemistries in 210 diabetics with elevated baseline liver enzymes (aspartate aminotransferase greater than 40 IU/L and/or alanine aminotransferase greater than 35 IU/L) and in 628 diabetics with normal baseline liver enzymes.

Compared with diabetics with normal baseline liver enzymes, those with elevated baseline liver enzymes did not have a higher incidence of mild to moderate (10% vs. 6%) or severe elevations in liver biochemistries (0.9% vs. 0.6%), the investigators report.

"Our study," Dr. Chalasani and colleagues conclude, "provides important information about the safety of rosiglitazone in diabetic patients with elevated baseline liver enzymes."

They also point out that "contrary to the manufacturers' recommendation, rosiglitazone was prescribed for 15 patients who had baseline liver enzymes 2.5 times the upper limit of normal, and they all appeared to have tolerated the rosiglitazone therapy with no evidence of hepatotoxicity."

This observation, the authors say, should prompt further study of the validity of the manufacturers' recommendations regarding rosiglitazone use in diabetics with elevated liver enzymes.

Am J Gastroenterol 2005;100:1317-1321.

Source: REUTERS

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