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Rapamune Yields Low Rejection Rates;
Other Transplantation Congress Findings Reported

MONTREAL · August 1, 1998 · by TNN Medical Reporter Virginia Baskerville

Rapamune (sirolimus/rapamycin), a new medication for preventing organ rejection, has significantly improved graft survival in two phase III clinical trials, the results of which were presented at the recent 17th World Congress of the Transplantation Society.

For the first time since the introduction of cyclosporine, the findings "have clearly demonstrated" the ability of a new drug to improve the longevity of grafts, said Barry D. Kahan, MD, PhD, of the University of Texas-Houston Health Science Center, who led the United States-based trial.

In the U.S. study, 719 recipients of kidney transplants at more than 40 centers received cyclosporine and prednisone along with either 5 mg of Rapamune daily, 2 mg of Rapamune, or azathioprine. Acute rejection episodes occurred in 10%, 15%, and 24% of patients, respectively.

Similar results occurred with the 576 patients who participated in the global study, which was conducted in Australia, the United States, Canada, and six European countries. In this study, the efficacy of 5 mg and 2 mg of Rapamune was compared to the effects of placebo, and all patients received cyclosporine and prednisone. Acute rejection occurred in 11% of patients who received 5 mg of Rapamune, 19% who received 2 mg of Rapamune, and 29% of patients treated with placebo.

"For transplant physicians and patients alike, these findings hold promise for an entirely new therapeutic approach," said lead investigator Allan S. MacDonald, MD, of Dalhousie University in Halifax, Nova Scotia. "The incidence of rejection in these two studies is the lowest ever reported in large-scale clinical trials."

Dr. MacDonald added that Rapamune holds promise for "modifying immunosuppressive therapies so they are significantly less toxic and result in greater graft survival."

A number of other findings presented at the congress, which was attended by about 4,000 medical professionals from 79 countries, attracted the attention of the press:

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