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Drug may keep transplanted kidneys healthier longer

Urine ProblemsAug 25, 05

Transplanted kidneys may survive three or four years longer when treated with an experimental Bristol-Myers Squibb Co. drug instead of the standard drug cyclosporine, a study released on Wednesday showed.

A test of 218 transplant recipients at 22 centers in North America and Europe found that the six-month rejection rate for kidneys treated with either drug was equally low.

But tests showed that the organs functioned much better when receiving the experimental drug belatacept, according to the study published in the New England Journal of Medicine.

Journal editors Julie Ingelfinger and Robert Schwartz cautioned that doctors “will need much more experience with belatacept before recommending it as a routine replacement for cyclosporine.”

Bristol-Myers Squibb paid for the study. Of the 15 named authors, four are employees of the company and seven have financial ties to it.

Cyclosporine “gives excellent short-term results. The problem is that over the long term, over the past 10 years, despite all the newer drugs that have been approved for transplantation, we have seen only a modest improvement in long-term organ survival,” Flavio Vincenti, the chief author of the study, told Reuters.

The problem is that cyclosporine-type drugs, while preventing the body from rejecting an organ, “can produce toxicity within the kidney, and ultimately many kidneys suffer significant damage. So early on they do an excellent job, but over the long term they do not provide significant improvement in the life of the kidney,” he said.

Cyclosporine, sold under the brand names Sandimmune or Neoral by Novartis, and related drugs also can promote heart disease.

Newer drugs like belatacept can be used without cyclosporine, said Vincenti of the University of California, San Francisco. The kidney function tests of the belatacept recipients “can be extrapolated to say these kidneys will last three to four years longer,” he said.

The study did not directly assess long-term kidney survival. It was only designed to see if belatacept was inferior to cyclosporine over the short term.

The researchers found that both drugs made patients just as prone to infection and just as likely to develop cancer. And even though more cyclosporine recipients were taking blood pressure or cholesterol medicine, the blood pressures and cholesterol readings of the belatacept recipients were similar or slightly lower.

Vincenti said one advantage of belatacept is that it is given intravenously once a month so patients don’t have to worry about taking pills every day. Some cyclosporine patients may skip their pills because of the side effects.

“You get assurance of compliance and the patient doesn’t have to deal with the daily toxicities of some of the drugs,” he said. “So this is a big improvement, I think.”



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