Rosiglitazone (Avandia) shows no sign of troglitazone-like liver toxicity, according to a study presented at the American Diabetes Association 60th Scientific Sessions meeting on June 12.
The Smithkline Beecham-supported study looked at levels of alanine aminotransferase (ALT), an enzyme that indicates liver damage if elevated, in patients taking the hypoglycaemic agent. The rate of elevated ALT levels was 0.30 cases per 100 patient years in the rosiglitazone group, compared with 0.59 cases per 100 patient years in the placebo group and 0.73 cases per 100 patient years for patients given a sulfonylurea or metformin. Rosiglitazone has been recommended for approval by the Committee for Proprietary Medicinal Products for treating type 2 diabetes, but only for use in combination with metformin or a sulphonylurea and only in defined patient groups.
A spokeswoman for Smithkline Beecham, manufacturer of Avandia, told The Journal on June 13 that SB expects Avandia to obtain European licensing within the next couple of months.