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The new studies reveal the trade-offs:
A two-year study gave 1,300 MS patients cladribine or dummy pills. Patients on the drug were only half as likely to suffer relapse as those on placebo, and were 30 percent less likely to have worsening disability. However, 20 percent to 30 percent of the cladribine patients developed low counts of infection-fighting white blood cells, compared to just 2 percent of the others. And 20 cladribine patients suffered herpes infections versus none in the dummy pill group.
A two-year study gave about 1,000 patients fingolimod or dummy pills. Only 17 percent of fingolimod patients had worsening disabilities from MS after three months, compared to 24 percent in those on placebo. Herpes infections were about the same in the pill and placebo groups, but respiratory infections like bronchitis and pneumonia were nearly twice as common in the fingolimod patients.
A one-year study of 1,200 patients tested fingolimod against shots of Avonex, a form of interferon. Those taking the pills had less brain shrinkage -- a measure of progression of the disease. About 20 percent of patients on the pill had relapses versus 30 percent on the dummy pills.
In that study, 9 percent of those on fingolimod had serious side effects, compared to 6 percent of those on Avonex. Two people on fingolimod died of herpes infections; six had eye swelling and eight had skin cancers.
All three studies were funded by Novartis or Merck Serono, the pill manufacturers.
Doctors are likely to turn first to current options until the pills' side effects are better understood, said Dr. Neil Lava, the director of Emory University's multiple sclerosis clinic.
Physicians are mindful of what happened with Tysabri, an MS drug that was approved in November 2004 and pulled from the market the next year after cases of a rare but lethal brain inflammation in some patients. It was reintroduced in 2006, but doctors are still monitoring for side effects, Lava said.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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