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Item #11
Liver
Function Testing Crucial with Thiazolidinediones, New Guidelines May
Be Too Aggressive
Testing
frequency might be safely modified or reduced based on the particular
drug prescribed and trends in (ALT) levels.
Preliminary
results of a study were presented December 11th at the
clinical meeting of the American Society of Health-System Pharmacists.
Frequent liver function monitoring is recommended for patients taking
thiazolidinediones, the drugs used as monotherapy or in combination
with other medications in treatment of type II diabetes. Recently
updated guidelines from the American Association of Clinical
Endocrinologists (AACE) call for monitoring liver function every two
months for the first year of treatment with thiazolidinediones-and
periodically thereafter-because of the high risk of hepatocellular
injury.
Researchers at the Central Alabama Veterans Health Care System
(CAVHCS) in Montgomery, Alabama, United States, are conducting an
ongoing study to determine whether liver function in patients taking
one of commonly prescribed thiazolidinediones, rosiglitazone (Avansia)
and pioglitazone (Actos), is appropriately monitored. The AACE
recommends that rosiglitazone be discontinued if ALT levels exceed
three times the upper limit of normal on two samples, and that
pioglitazone be discontinued if ATL exceeds 2.5 times the upper limit
of normal.
A total of 53 patients, with a mean age of 67 and predominantly male,
were evaluated in a retrospective, randomised, observational analysis.
The researchers sought to determine whether the patients were being
monitored appropriately and whether significant ALT increases prompted
discontinuation of the medication. The results were based on the
monitoring activities during the first year following initiation of
treatment.
The researchers found that although ALT values declined steadily over
the course of the first year of treatment, indicating efficacy of
treatment and no need to discontinue the medications, patients' liver
function was not being monitored according to AACE guidelines. The
average time between liver checks, after baseline, ranged from 84 days
to 157 days, and six patients were monitored only at baseline.
However, the researchers noted that the average ALT values in the
study group (from 21 at first check to 19 at third check) might
indicate that rosiglitazone and pioglitazone do not require the liver
monitoring frequency required by an earlier thiazolidinedione,
troglitazone (Rezulin), which was voluntarily removed from the market
in 2000 because of the high incidence of liver injury.
================================
DID
YOU KNOW:
While
cardiovascular disease mortality and in particular coronary heart
disease related deaths have declined in those without diabetes in
developed countries, in men with diabetes the decrease has been a
modest 13% while in women with diabetes the rates have actually
increased by 23%. International
Diabetes Federation, 2000.
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