Studies
Reveal Good News Regarding Liver Safety of Pioglitazone
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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