| George DeCarlo 2005-03-11, 11:23 am |
| http://www.aegis.com/default.asp
Source: GlaxoSmithKline
CONTACT: Mary Faye Dark of GSK, +1-919-483-2839; or Beth Schlesinger of
PCI, +1-312-558-1770
Kidney Dysfunction in HIV Patients May Be Detected Earlier Using
Estimated GFR Compared to Measures of Serum Creatinine Only
PRNewswire - February 28, 2005
RESEARCH TRIANGLE PARK, N.C. -- Tracking the subtle kidney damage that
can lead to chronic kidney disease in HIV patients is increasingly
important as people survive longer and may have an increased risk of
renal dysfunction as a result of their disease, therapy-related damage,
or co-morbid conditions such as diabetes mellitus and hypertension.
Researchers have reported on a potentially more sensitive marker for
the early detection of renal impairment than the marker currently
considered the standard. Results were reported during the 12th
Conference on Retroviruses and Opportunistic Infections (CROI).
In an observational study involving 1,625 patients from the CHORUS
Cohort, five times more patients were identified as having stage 3
kidney disease by estimating glomerular filtration rate (GFR) rather
than testing for the traditional marker, serum creatinine (sCr) levels.
The two markers detected a comparable number of patients with stage 4
chronic kidney disease.
"The National Kidney Foundation has stated that GFR is the best overall
indicator of kidney function, especially in patients with co-morbid
conditions, and recently indicated that the use of serum creatinine
alone may not be suitable for the detection of renal impairment," said
Stephen L. Becker, M.D., Pacific Horizon Medical Group, San Francisco,
who presented the study. Because 24 hour urines were not collected in
the CHORUS Cohort, GFRs were estimated.
"More than 10 percent of our patients had renal dysfunction using the
GFR Stage 3+ criterion, a level defined by the National Kidney
Foundation as chronic kidney disease," Dr. Becker said. Only about 2
percent of Grade 1+ sCr elevations would have been identified using sCr
alone.
Of 20 clinical events related to renal insufficiency observed in the
study population, 45 percent were predicted based on sCr levels alone,
compared to 95 percent predicted by GFR.
Elevation in the level of creatinine is a marker of kidney function.
Estimated GFR takes into account sCr levels, but also considers other
variables such as age, race and sex that affect sCr.
Overall, the elevations in sCr observed in CHORUS were consistent with
those seen in other populations, and the proportion of patients with
extreme Stage 4+ GFR values was comparable to results seen for Grade 4+
sCr in other studies.
"HIV positive people are living longer as advances continue to be made
in treatment and more drug options are available. The challenge now is
to keep people healthy and to detect early on if a particular factor
might be causing damage," said Doug Manion, M.D., vice president for
HIV Clinical Research for the Infectious Diseases Medicines Development
Center (MDC), GlaxoSmithKline. "This study suggests that estimated GFR
may be a more sensitive marker that will help healthcare providers
detect and treat kidney problems earlier than with sCr alone," he said.
Further study of renal function in patients treated with a wide range
of antiretroviral agents is planned for the future.
CHORUS (Collaborations in HIV Outcomes Research - U.S.) is an
observational research database initiated in 1997 and with an
enrollment of more than 8,000 patients in 7 study sites. It is a
longitudinal study that collects data in the course of regular medical
care and through periodic questionnaires.
CHORUS is funded by GlaxoSmithKline, but is overseen by an independent
scientific board of physicians and other HIV experts.
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV
research and therapies. GSK is a leader in the development of fixed
dose combination products. The company is engaged in basic research
programs designed to investigate new targets to treat HIV.
GSK's Bridges to Access program can help provide qualified individuals
with access to GSK's antiretroviral medications, as well as help
identify insurance or other support for medications. Patients may be
eligible for this program if they are not eligible for prescription
drug benefits through any other private or public insurer, payer, or
program. In 2004, GlaxoSmithKline donated more than $372.5 million
worth of prescription drugs to 475,000 patients. For more information,
visit http://www.bridgestoaccess.gsk.com/ or call 1-866-PATIENT.
At A Glance
-- Estimated glomerular filtration rate (GFR) may be a more sensitive
indicator of kidney function in HIV patients than serum creatinine
(sCr) levels.
-- GFR detected Stage 3+ renal insufficiency in more than 10 percent of
patients, whereas only 2 percent of 1+ Grade sCr elevates would have
been detected using sCr alone.
-- According to the National Kidney Foundation, GFR is the best overall
indicator of kidney function.
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