Abnormal liver test results found in
people
with multiple sclerosis in placebo arms of clinical trials
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Medical Update Memo
November 1, 2006
SUMMARY
Researchers at the University of British
Columbia report people with MS or clinically
isolated
syndrome (CIS) who were in the placebo
(non-treated) groups of clinical trials
have greater than
expected abnormal liver test results. The
study was reported in the October 10, 2006
issue of Neurology and used data from the
Sylvia Lawry MS Research Centre in Munich,
Germany. Lead investigator Dr. Helen Tremlett
advises people with MS and their physicians
need to take extra care with medications
that might affect the liver and to consider
routine liver testing with some medications.
Dr. Tremlett is funded by the MS Society
of Canada through a Dr. Donald Paty Career
Development Award.
DETAILS
Dr. Helen Tremlett and colleagues at the University
of British Columbia used data from the Sylvia
Lawry MS Research Centre in Munich, Germany
to obtain liver test results from 813 people
with definite MS and clinically isolated
syndrome (CIS – people who have had
one symptom characteristic of MS). The 813
people had been assigned to the placebo groups
of 16 randomized controlled trials. The Sylvia
Lawry MS Research Centre has the largest
database of clinical trial information in
the world.
The researchers report in
Neurology (2006; 67:305-310) by year one nearly
20
percent of
the 813 people had abnormal alanine aminotransferase
(ALT) test results. By year two this had
increased to more than 25 percent. Over the
two-year
period, there was an over three-fold increased
risk of a person with MS having an elevated
liver test result compared to expectations.
The researchers also note overall the risk
of severe liver test abnormalities was low.
The ALT test is the most
specific liver test. ALT is an enzyme that
is produced in the liver
cells. ALT levels generally increase in situations
where there is damage to the liver cell membranes.
Such leakage into the blood stream may be
an indicator of liver cell damage.
Risk factors
for having an abnormal liver test were male
gender and higher body mass
index (BMI) over each time period (at the
first recorded test as well as over the first
year
and the whole study). People with relapsing-remitting
MS and a shorter disease duration were at
an increased risk of an abnormal ALT test over
the whole study period. Other liver tests
found
abnormal results associated with an older
age and relapses in the previous 12 months.
In
an earlier study also funded by the MS Society
of Canada, Dr. Tremlett and Dr. Joël
Oger (also of the University of British Columbia)
found beta interferons, prescribed to modify
the course of MS, can also increase the risk
of an elevated liver test. The current study
did not include people on beta interferon therapy.
Commenting
on the study results, Dr. Tremlett said it
is now known abnormal liver tests can
result independently of beta interferon therapy.
She added, “I would recommend people
with MS have their liver tested as a routine
part of their care when being treated with
drugs known to affect the liver. In addition,
people should inform their doctors immediately
if they have liver disease symptoms such as
jaundice (yellow of the skin or whites of the
eye), itchy skin and unexpected itching.”
ASK MS Information System Code: 1.1.6.j
National Research Department
National Marketing and Communications Department
Disclaimer
The Multiple Sclerosis Society of Canada is an independent,
voluntary health agency and does not approve, endorse or
recommend any specific product or therapy but provides
information to assist individuals in making their own decisions.
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