Long-term steroid therapy may not be necessary for kidney transplant patients.

Long-term use of a medicine used to treat kidney transplant patients may not be necessary in people at low to moderate risk of organ rejection, according to the results of a study conducted by a transplant researcher from the University of Cincinnati.

The randomized clinical trial involving 385 patients receiving immunosuppressants tacrolimus and mycophenolate investigated whether the use of these drugs called corticosteroids could be eliminated seven days after kidney transplantation. The study shows that 15 years after transplantation, no difference in kidney transplant survival or patient survival rates was found between patients who received long-term corticosteroids versus those who had long-term corticosteroids. corticosteroids cleared early, says E. Steve Woodle, MD, William A. Altemeier Endowed President and Professor of Surgery at UC College of Medicine, and Study Leader.

“There are many reasons to stop corticosteroids as soon as possible,” says Woodle, also director of solid organ transplantation at UC Health. “Historically, the main complaint expressed by transplant patients concerns the various side effects of corticosteroids. They really dislike the disfiguring effects of steroids including changes in body shape with abnormal distribution of fat.

“Corticosteroids make their faces round, and they often develop stretch marks on their skin too,” says Woodle. “Acne is particularly problematic in young people and adolescents with transplants. Beyond cosmetic effects, corticosteroids cause bone disease and lead to loss of collagen in tissue, easily causing skin bruising. Diabetes, hypertension and high cholesterol increase cardiovascular complications, which in the long term reduce patient survival. “

The results of the study were published online in JAMA surgery.

The prospective trial was randomized and double-blind, meaning doctors and patients were unsure whether they were receiving the drug or a placebo and involved patients recruited from 28 multiple kidney transplant sites. At the initial five-year end of the study, there was no difference in mortality rates from transplantation or other causes in the two groups, Woodle says.

Moderate to severe short-term organ rejection rates also did not differ, but there was a higher rate of biopsy-confirmed signs of rejection (samples were taken from the transplanted kidney) in patients discontinued from taking corticosteroids compared to those who continued to take corticosteroids. . Signs confirmed by biopsy were 7% higher in non-corticosteroid patients, but doctors were able to reverse that impact with limited corticosteroid use, Woodle explains.

During this time, kidney function was similar between the corticosteroid and non-corticosteroid groups, but weight gain, serum triglyceride levels, and levels of diabetes requiring insulin were lower in patients discontinued on corticosteroids.

“The current study extended patient follow-up to more than 15 years using data from the UNOS National Transplant Database,” says Rita Alloway, PharmD, research professor in the UC Division of Nephrology , Kidney CARE and study co-author. “Interestingly, a guest commentary on this 15-year report suggested that doctors should no longer use corticosteroids unless there is a justifiable reason.”

The study result could impact the treatment of more than 22,000 people who received kidney transplants in the United States last year. In the United States, more than 97,000 patients are on a waiting list for a kidney transplant. Woodle first tested the corticosteroid-free diet in 1995 and it remains the standard of care at UC today.

“This study is the culmination of 30 years of work in an attempt to eliminate the morbidity associated with corticosteroid use in transplant patients,” says Woodle. “This confirms that you are not paying a price in terms of kidney life and patient life if you take corticosteroids early.”