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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

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.

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

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