Cutting Back on Steroids Can Help Kidney Transplant Patients
Published August 2006
Preliminary results of a study led by UC scientists suggest that reducing corticosteroid treatment in kidney transplant patients significantly lowers toxic side effects of antirejection drugs without affecting survival rates.
Steroids are given in combination with other anti-rejection drugs to help suppress the body’s immune system and allow the transplanted organ to function properly.
Previous research, however, has linked steroids to an increased risk for cardiovascular disease, high cholesterol and blood pressure, weight gain, diabetes, cataracts and other side effects.
“The drug transplant patients dislike most is steroids,” says Steve Woodle, MD, director of the transplantation at UC and
principal investigator for the study. “They see how the drug’s toxicity affects their bodies—their faces swell, they gain weight, they bruise easily— and they know steroids are the cause.”
Steroid-free regimens could reduce health-care costs from transplant-related problems and improve the patients’ quality of life,
Despite the known negative side effects of steroids, Woodle says, physicians have feared that removing them would increase the risk for organ rejection.
“This study shows that, when corticosteroids are used in combination with the right immunosuppressive agents, we can minimize that rejection risk, while also reducing the negative side effects of steroid use,” he says.
The team’s findings were reported July 24 at the meeting of the World Transplant Congress in Boston, where UC researchers presented 55 abstracts and oral presentations, 10 of which related to the corticosteroid withdrawal trial.
This multicenter trial is the first in which corticosteroids were removed prior to 90 days after kidney transplant. The results presented were for the first three years of a projected five-year investigation.
The researchers found that patients who received just seven days of the corticosteroid prednisone after kidney transplant had the same transplant organ survival rate and functionality as those on continuous corticosteroids. In addition, patients on short-term steroids experienced significantly less cardiovascular risk.
These findings, Woodle says, contradict results from a 1995 Canadian study that claimed steroid-free patients begin to lose their transplant organs three years after surgery.
Woodle’s team found that the acute rejection rate for steroid-free patients was 16 percent—just slightly higher than the nationwide average of 15 percent. Steroid-free patients, however, reaped substantial health benefits, including reduced cardiovascular risk and weight gain.
Rita Alloway, PharmD, a research professor at UC and coinvestigator on the study, adds, “Now we need to further quantify the benefits of steroid-free regimens and their impact on health risks to provide the very best, holistic care to our patients.”
UC researchers also found that African-Americans—long excluded from transplant research trials because of a perceived risk for increased acute rejection—are not at any greater risk for rejection than Caucasians and actually enjoy even greater benefits in terms of cardiovascular risk reduction.
Nationwide, the trial enrolled 397 patients, who were then randomized to either a seven-day or a lifetime course of corticosteroid therapy, which started within the first three days of transplant.
Patients in both groups received the steroids in combination with twice-daily immunosuppressive agents designed to help lower the body’s natural immunity to the transplant organ.
The trial was conducted at 26 medical centers across the United States, including UC and the universities of Memphis, Tennessee, Utah and Washington.
Woodle and researchers at the participating institutions received honoraria and nominal research grants from the study sponsor, Astellas Pharmaceuticals.