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Painful condition affecting kidney
failure patients increases risk of death
Mass. General study supports
association of newly reported disorder with imaging contrast agent
BOSTON - September 28, 2007 - A painful and debilitating
condition that affects patients with kidney failure may be more
common than previously believed and appears to be strongly associated
with prior exposure to certain contrast agents used in imaging studies.
In addition, individuals with this syndrome - called nephrogenic
systemic fibrosis (NSF) - appear to have a significantly increased
risk of dying. The findings from Massachusetts General Hospital
(MGH) investigators appear in the October issue of the journal Arthritis
& Rheumatism.
"Our analysis found that hemodialysis patients who had undergone
imaging studies using a gadolinium-containing contrast agent have
more than 10 times the risk of developing NSF as do patients with
no prior exposure to gadolinium," says Jonathan Kay, MD, director
of the Rheumatology Clinical Research Unit at MGH, the report's
senior author. "Among those with NSF, the risk of dying within
two years was three to five times greater than for patients without
the condition from the same dialysis centers."
The primary symptoms of NSF are rapid and progressive thickening,
hardening and darkening of the skin, primarily on the arms and legs.
Originally believed to affect only the skin, the condition now is
known to involve internal organs. NSF can be extremely painful,
causing the skin to contract to the point where movement is difficult
or impossible. The condition has been reported only during the past
10 years and only among patients with abnormal kidney function,
primarily those with advanced kidney disease. In 2006, an Austrian
physician noted that NSF developed in several of his dialysis patients
who had undergone MR imaging studies using gadolinium-containing
contrast.
Reports of NSF in the medical literature have discussed only small
numbers of cases and have not included comparative information from
patients shown to not have the disorder. To better assess the prevalence
of NSF among patients with advanced kidney disease and to examine
a potential association with gadolinium-containing contrast agents,
the team led by Derrick J. Todd, MD, PhD, now a rheumatology fellow
at the Brigham & Women's Hospital, enrolled hemodialysis patients
treated at six outpatient centers in the Boston area.
The investigators devised a simple examination to check for the
three skin features of NSF - tightening, thickening and darkening
- and also collected demographic information. Available electronic
medical records for participants were analyzed for any history of
imaging studies, predominantly MRI examinations, using gadolinium-containing
contrast.
Among 186 study participants, 25 (13 percent) were determined to
have NSF based on the presence of at least two of the three skin
findings. Examination of skin biopsy samples from five study participants
supported the examination-based diagnosis of NSF in each. Electronic
medical records were available for 90 participants; 17 of those
had a skin examination consistent with NSF, all but one with documented
prior exposure to gadolinium. The investigators were particularly
surprised to find that 48 percent of participants with skin changes
of NSF died within two years of their examination. Among participants
without NSF, the death rate was 20 percent, which would be expected
among patients with advanced kidney failure undergoing long-term
hemodialysis treatment.
"Our study demonstrates a definite and very strong association
between exposure to gadolinium-containing contrast and the subsequent
development of NSF," says Kay, an associate clinical professor
of Medicine at Harvard Medical School. "We need to address
the mechanism by which this devastating disease occurs and develop
effective treatment and preventive strategies, so that gadolinium-containing
contrast agents - which provide important clinical information -
can be used safely in patients with kidney failure."
At this time, Kay notes, patients scheduled to undergo such imaging
studies should first have their kidney function checked, and gadolinium-containing
contrast should not be used in those with significant underlying
kidney disease. More information is needed to determine the risk
for those with milder forms of kidney disease. The study was conducted
by Todd and co-author Anna Kagan, MD, PhD, while they were medical
residents at MGH. Lori B. Chibnik of Brigham and Women's Hospital
was the study's biostatician.
Massachusetts General Hospital, established in 1811, is the original
and largest teaching hospital of Harvard Medical School. The MGH
conducts the largest hospital-based research program in the United
States, with an annual research budget of more than $500 million
and major research centers in AIDS, cardiovascular research, cancer,
computational and integrative biology, cutaneous biology, human
genetics, medical imaging, neurodegenerative disorders, regenerative
medicine, systems biology, transplantation biology and photomedicine.
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Media Contacts: Sue
McGreevey, MGH Public Affairs
Physician Referral Service: 1-800-388-4644
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