Corticosteroid cessation demonstrates long-term safety for kidney transplant recipients
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Researchers who compared kidney transplant recipients randomized to withdrawal or continue corticosteroids 7 days after the procedure found no difference in allograft survival at 15 years.
This led E. Steve Woodle, MD, of the college of medicine at the University of Cincinnati, and colleagues to conclude long-term use of the therapy may be unnecessary.
“The adverse effects of corticosteroids have prompted attempts to eliminate these drugs from treatment regimens,” the researchers wrote, citing a study from 2008 that showed no difference in mortality, allograft loss, short-term rejection or kidney function between patients who continued corticosteroids and those who did not. They contended corticosteroid withdrawal was associated with improved outcomes, including a lower likelihood of weight gain, serum triglyceride levels and insulin-requiring diabetes.
“Subsequently, single-center studies have reported acceptable 10- and 15-year outcomes in patients withdrawn from corticosteroids compared with historical controls,” the researchers wrote. “Despite this evidence, only 30% of transplant recipients are treated with corticosteroid withdrawal.”
To further investigate, Woodle and colleagues conducted a prospective, multicenter, randomized double-blind placebo-controlled trial that included 385 transplant recipients deemed low to moderate immune risk who did not have delayed graft function or short-term rejection in the first week after transplant.
Patients were randomized to receive tacrolimus and mycophenolate mofetil with (n = 194) or without corticosteroids (n = 191) 7 days after transplant.
Results indicated no significant differences between groups regarding patient survival, allograft failure from any cause, including death (adjusted HR = 0.83), or allograft failure censored for death (aHR = 0.78).
In a related commentary, Arthur J. Matas, MD, of the division of transplantation in the department of surgery at the University of Minnesota, cited a study from 1998, which was the “first to report successful transplants without prednisone.” Since then, he noted, there have been many single-center studies showing success with early steroid cessation.
“The authors question why [early steroid cessation] ESC is not used more widely,” Matas wrote, indicating his agreement with the practice.
“The success of ESC has led most (noncessation) centers to rapidly reduce prednisone to 5 mg per day,” he added. “However, even this low dose is associated with complications (eg, osteoporosis, fractures). The Woodle [and colleagues] study provides convincing long-term data showing that recipients of transplants are not penalized by ESC. Going forward, in contrast with justifying ESC, transplant centers using steroids should justify why they are using steroids for their recipients or recipient subpopulations, given that there is no evidence of improved outcomes and steroids have adverse effects.”
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