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PIO continues to demonstrate its safety. The overwhelming majority of type 2 diabetics taking pioglitazone (PIO) in combination with sulfonylureas (SU), metaformin (MET), or insulin, had reductions in alanine transaminase levels, according to the results of 3 new studies.
The first thiazolidinedione to be commercially introduced, troglitazone, was removed from the market on March 21, 2000, after the FDA reported it was investigating 63 confirmed fatalities involving the drug. Continuing studies of troglitazone showed increases in alanine transaminase levels of more than 3 times normal indicating liver toxicity in significant numbers of troglitazone users.
In contrast, continuing studies of PIO show reductions of alanine transaminase levels in the overwhelming majority of type 2 patients. “Our studies show that PIO decreases in normal levels of transaminase and bilirubin so we don’t have the same risk and, in all these studies, there were very little liver problems,” says Frederick T. Murray, M.D., Director of Medical affairs for Takeda Pharmaceuticals North America, Inc. Dr. Murray is an author of 3 of the studies presented at the 12th Annual Meeting & Clinical Congress of the American Association of Clinical Endocrinologists May 14 – 18 in San Diego, California.
The studies involved 2,219 participants. A total of 521 completed the double-blind portion of the PIO and SU study, 561 completed the PIO plus MET study, and 690 subjects completed the PIO plus insulin study.
“In all the combination studies, no subject discontinued the study due to adverse events of increased hepatic enzymes, and no subjects discontinued due to hepatocellular damage,” said Dr. Murray and his colleagues in the presentation. “In the 3 studies, a total of 5 subjects had ALT increases greater than 3 times the upper limit of normal and, of these subjects, 3 had ALT increases greater than 3 times the upper limits of normal during the PIO treatment period.”
“In all 3 studies, subjects with increased ALT experienced adverse events that were reported as mild or moderate in intensity,” Dr. Murray and his colleagues continued. “No serious events regarding ALT, AST, or total bilirubin were reported for any subjects in any of the 3 studies. No subjects discontinued any of the studies due to adverse events of increased hepatic enzymes or hepatocellular damage.” [Study title: Reductions of Alanine Transaminase Levels in Patients with Type 2 Diabetes Mellitus Treated with Pioglitazone Plus Sulfonylurea or Metformin. Abstract #26, P-298-299]
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