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( BW)(CA-PACKARD-CHILDRENS-HOSP) New Drug Approach Avoids Side
Effects in Children Receiving Kidney Transplants Business Editors,
Health/Medical Writers PALO ALTO, Calif.--(BW HealthWire)--May 17,
2001--Steroids -- long a staple medication for avoiding rejection of newly
transplanted organs -- can cause serious side effects in children, ranging from
high blood pressure and acne to impaired growth and an abnormally round, puffy
face. Now these side effects can be avoided -- possibly with improved function
in the transplanted kidneys -- by means of a new regimen of drugs developed and
tested by researchers at the Lucile Packard Children's Hospital at Stanford
University and the Stanford University School of Medicine. Early results also
suggest that the new drug protocol could potentially be extended to other organ
transplant procedures and to patients of different age ranges. The results of
the Stanford study on the new drug protocol were presented by co-researchers
Minnie Sarwal, M. D., Ph.D. and Oscar Salvatierra, M.D., to the combined
meeting of American Societies of Transplantation and Transplant Surgeons in
Chicago on May 15. While the drawbacks to steroids have long been known, there
didn't seem to be any viable alternative, according to Salvatierra, who is
professor of pediatrics and surgery at the Stanford Medical School and director
of the pediatric kidney transplant program at the Children's Hospital.
"Transplant surgeons have been using steroids for over forty years because they
suppress the immune system and keep it from attacking the new organ as an
invader," Salvatierra said. "The side effects, though, pose a real problem,
especially in children. Steroids can lead to hypertension, abnormally high
blood fat levels, acne, mood swings, diabetes, slow wound healing, soft bones,
impaired growth, and a puffy facial appearance." Sarwal, Salvatierra and other
researchers on the team -- including Dr. Stephen Alexander, Dr. Peter Yorgin,
and Dr. Maria Mallan -- believe that these side effects could account for the
peak in rejection rates in adolescents, who suffer the most transplanted-organ
loss of any age group. Concerned about their appearance, teenagers may fail to
take the drugs and suffer rejection of the transplant as a consequence. Past
attempts to withdraw steroids shortly after surgery or to reduce the dosage as
a way of limiting the side effects backfired, causing higher-than-normal
rejection. "We began thinking that maybe this approach was all wrong, that
withdrawal of steroids failed because the immune system had already become
dependent on them, then rebounded when they were withdrawn," said molecular
geneticist Minnie Sarwal, M.D., Ph.D., an assistant professor of pediatric
nephrology at Stanford. "Dr. Salvatierra and I decided to try a steroid-free
immunosuppressive drug protocol, both pre- and postoperatively." The research
team developed a regimen of new drugs known to suppress the immune system with
fewer or lesser side effects, then studied it in 10 kidney-transplant patients
aged 5 to 21 years. The steroid-free patients showed excellent results compared
to a control group on standard treatment including steroids. As a result,
another 11 patients, five of whom are younger than 5, have been added to the
study group. "Thus far, we have had only one instance of acute clinical
rejection, and it was mild and easily controlled," Salvatierra said. "This is
an exceptionally good outcome." "It's been wonderful to walk into the clinic
and see these children look completely normal," Sarwal added. "You can't tell
these children have been transplanted. In the past it was always evident who
had been transplanted -- they were short, they had round faces, extra hair,
acne. Now we maintain them on just two drugs long-term, and they don't have
blood pressure or blood fat problems. They look wonderful, and they are growing
like weeds." The Stanford researchers suspect that the absence of high blood
pressure and elevated blood fat will lead to improved kidney function over
time. In addition, the steroid-free drug protocol should work with transplants
other than kidneys and in patients of all ages. "The kidney is highly
immunogenic," Salvatierra said, "and children are the most difficult patients.
Therefore, if this protocol continues to prove successful with pediatric kidney
recipients, it would have profound implications across the entire field of
organ transplantation." The paper on the steroid-free protocol will be
published in Transplantation later this year. Lucile Packard Children's
Hospital at Stanford is a 240-bed hospital devoted entirely to the care of
children and expectant mothers. Providing pediatric medical and surgical
services associated with Stanford University Medical Center, Packard offers
patients locally, regionally and nationally the full range of health care
programs and services -- from preventative and routine care to the diagnosis
and treatment of serious illness and injury.
CONTACT: Lucile Packard
Children's Hospital
Bettylu Smith,650/497-8364 or 650/371-2952 (Pager)
lpchmedia@medcenter.stanford.edu
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