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Low-Dose Tacrolimus Appears to Fare Best in Symphony Trial: Presented at WTC

By Ed Susman

BOSTON, MA -- July 26, 2006 -- A comparison of 4 different methods of immunosuppression for transplant patients indicates that a low-dose tacrolimus regimen performed best, researchers said here at the World Transplant Congress (WTC).

The prospective open-label study, titled SYMPHONY, enrolled 1,645 patients in 83 sites and 15 countries, and compared a standard dose of cyclosporine with low-dose regimens of tacrolimus, sirolimus, and cyclosporine.

Patients were also treated with mycophenolate mofetil and steroids, and underwent induction treatment with daclizumab, said presenter Henrik Ekberg, MD, professor of medicine, Lund University, Lund, Sweden, in his oral presentation on July 24^th.

"New immunosuppressant drugs have successfully reduced the rejection rates of the new organ," Dr. Ekberg said. "However, patients still face developing serious side effects from the life-long use of some of these drugs. The focus is now to define the optimal balance of these combinations in order to prolong further the life of the patient and their transplanted organ."

After 1 year, graft survival was 94.2% for the low-dose tacrolimus patients, 93.1% for the low-dose cyclosporine patients, 90% for the standard-dose cyclosporine patients, and 89.2% for the low-dose sirolimus patients.

Acute rejection episodes were also lower in the low-dose tacrolimus arm, with 11.2% of patients experiencing an acute rejection episode at 6 months, and 12.3% at 12 months. After 1 year 23.5% of low-dose cyclosporine patients, 25.3% of standard-regimen cyclosporine patients and 35.3% of low-dose sirolimus patients had bouts of acute rejection. Dr. Ekberg said the differences between the low-dose tacrolimus groups and the other regimens proved significant at the P < .01 level.

The 402 patients assigned to low-dose tacrolimus achieved a glomerular filtration rate of 65.4 mL per minute, compared with 60.9 with low-dose cyclosporine, 57.3 with low-dose sirolimus, and 56.8 with standard dose cyclosporine. The differences between the low-dose tacrolimus groups and the other regimens proved significant at the P < .05 level, Dr. Ekberg said.

Patient survival, however, did not significantly differ between groups after 1 year, with survival rates of 98.2% with low-dose cyclosporine, 97.2% with low-dose tacrolimus, 96.8% with low-dose sirolimus, and 96.5% with standard cyclosporine.


[Presentation title: Symphony Comparing Standard Immunosuppression to Low-Dose Cyclosporine, Tacrolimus or Sirolimus in Combination With MMF, Daclizumab and Corticosteroids in Renal Transplantation. Abstract 49]

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