Older Drug Better Than New for Blood Cell Disorder

BOSTON (Reuters) - The older generic drug hydroxyurea, if combined with a small dose of aspirin and given to people with thrombocythemia, is more effective in preventing serious bleeding and other complications than the newer and more expensive Agrylin, according to a study.

Agrylin, also known as anagrelide, is made by Roberts Pharmaceuticals, which merged with Shire Pharmaceuticals Group in 1999.

Thrombocythemia occurs when too many blood-clotting structures known as platelets are produced in the bone marrow. It can affect other types of blood cells and can cause a host of problems including chest pain, bleeding, and leg and lung clots. It usually strikes in middle age, affecting 1 in 30,000 people.

Although hydroxyurea has been a mainstay treatment for years, there have been concerns that it might cause leukemia. The effectiveness of Agrylin, which is a more expensive alternative, has not been well tested until now, according to the authors of a study published in Thursday's New England Journal of Medicine.

At 138 centers in the United Kingdom, Ireland and Australia, a group led by Claire Harrison of the University of Cambridge followed more than 800 volunteers for an average of 39 months. It found that Agrylin recipients were 57 percent more likely to suffer serious problems connected with thrombocythemia.

Agrylin recipients were nearly six times more likely to suffer a small stroke, and 3 1/2 times more at risk of developing serious stomach bleeding than those who were administered hydroxyurea.

In addition, "patients receiving anagrelide were more likely to withdraw from their assigned treatment" because of side effects, Harrison and her colleagues reported.

The results were so dramatic, the study was halted early so doctors could be informed of the findings.

In a Journal editorial, Tiziano Barbui and Guido Finazzi of Ospedali Riuniti in Bergamo, Italy, said "for now, hydroxyurea plus aspirin should be the standard of treatment for patients with essential thrombocythemia" whose disease makes them vulnerable to blood clots.