Reuters Health Information (2005-07-12): Rosiglitazone safe in diabetics with elevated liver enzymes: study
Rosiglitazone safe in diabetics with elevated liver enzymes: study
Last Updated: 2005-07-12 15:52:15 -0400 (Reuters Health)
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,
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.