Findings Presented at American Society of Nephrology Annual Meeting
CAMBRIDGE, Mass., Nov. 16 /PRNewswire-FirstCall/ -- Genzyme Corp.
(Nasdaq: GENZ) announced today that patients using Renagel(R) (sevelamer
hydrochloride) experienced lower rates of hospitalization, fewer days in
the hospital, and reduced overall health care expenditures compared to
patients treated with calcium-based phosphate binders according to the
largest prospective dialysis outcomes study ever conducted.
The findings -- drawn from the Dialysis Clinical Outcomes Revisited
(DCOR) trial -- were highlighted in two presentations today at the American
Society of Nephrology annual meeting in San Diego by a team of study
investigators led by Wendy St. Peter, Pharm D, of the Chronic Disease
Research Group and the University of Minnesota College of Pharmacy.
According to the study investigators, patients treated with Renagel
achieved an 11.0 percent reduction in the rate of all-cause hospitalization
and a 13.3 percent reduction in the number of days spent in the hospital
compared with patients using calcium-based phosphate binders -- results
that were statistically significant. Cause-specific hospitalization rates,
hospitalization days and morbidity were not statistically different between
the two groups.
The difference seen in hospitalizations drove a reduction in overall
Medicare costs for patients on Renagel relative to those taking
calcium-based binders, as measured in the study. Patients treated with
Renagel had costs that were, on average, $2,388 (3.7 percent) less per year
than those treated with calcium-based binders. Outpatient, skilled nursing
and other costs were not statistically different between the two treatment
groups, according to the investigators. Oral medication costs, including
phosphate binders, were not included in the analysis because at the time of
the study most oral medications were not covered by Medicare.
Hospitalization, morbidity and cost outcomes were pre-specified
secondary outcomes of the DCOR trial. The results presented today derive
from analysis of combined data from DCOR and from the Centers for Medicare
and Medicaid Services (CMS) end-stage renal disease database. Because
Medicare funds dialysis treatment, the vast majority (1,895 or 93 percent)
of patients enrolled in the DCOR study had Medicare as their primary payer.
Hospitalization, outpatient utilization and cost data were drawn from
Medicare inpatient and outpatient claims. The patients in this study were
followed from the first day patients took either study medication.
About the DCOR Study
The DCOR study enrolled 2,103 adult hemodialysis patients at 75 sites
in the United States. Patients were randomly assigned to either Renagel or
calcium-based binders (PhosLo(R) (calcium acetate) or TUMS(R) (calcium
carbonate)). Approximately 27 percent of patients in the calcium group
opted to use calcium carbonate rather than PhosLo. Patients were treated
according to the usual treatment guidelines in their dialysis center in
order to capture the real world experience of those on dialysis. Patients
were followed for up to 45 months. The study population for both treatment
groups was similar for demographics and baseline clinical characteristics,
and similar to the overall U.S. dialysis population.
A portion of the data reported here has been supplied by the United
States Renal Data System (USRDS). The interpretation and reporting of these
data are the responsibility of the author(s) and in no way should be seen
as an official policy or interpretation of the U.S. government.
About Renagel
Renagel controls serum phosphorus in patients with Chronic Kidney
Disease on hemodialysis. Controlling serum phosphorus is an important
element in the care of hemodialysis patients. Elevated serum phosphorus
levels are common in dialysis patients and associated with increased risk
of cardiovascular mortality. Renagel provides the added benefit of
significant LDL cholesterol reduction (32 percent).
The National Kidney Foundation's 2003 K/DOQI guidelines for Bone
Metabolism and Disease in Chronic Kidney Disease recommend sevelamer
hydrochloride as a first-line treatment option to control phosphorus.
Renagel is the only phosphate binder available that does not contain either
calcium or a metal. It has an established safety profile, is not
systemically absorbed and provides phosphorus control without the concerns
of calcium or metal accumulation. Renagel is used by more than 350,000
people worldwide.
Product Information
Renagel is indicated for the control of serum phosphorus in patients
with chronic kidney disease (CKD) on hemodialysis. Renagel is
contraindicated in patients with hypophosphatemia or bowel obstruction. In
a 52-week study, the most common side effects included vomiting, nausea,
diarrhea, and dyspepsia. Drug-drug interactions may occur with some
medications and should be taken into consideration when instructing
patients how to take Renagel.
For more information about Renagel, including complete prescribing
information, please visit http://www.renagel.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. This year marks the 25th anniversary of Genzyme's
founding. Since 1981, the company has grown from a small start-up to a
diversified enterprise with more than 8,500 employees in locations spanning
the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by
FORTUNE as one of the "100 Best Companies to Work for" in the United
States.
With many established products and services helping patients in more
than 80 countries, Genzyme is a leader in the effort to develop and apply
the most advanced technologies in the life sciences. The company's products
and services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant and immune diseases, and diagnostic
testing. Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as heart
disease and other areas of unmet medical need.
Genzyme(R) and Renagel(R) are registered trademarks of Genzyme
Corporation.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line
at 1-800-905-4369 within the United States or 1-703-797-1866 outside the
United States.
Media Contact: Investor Contact:
Dan Quinn Sally Curley
(617) 768-6849 (617) 768-6140
SOURCE Genzyme Corp.
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Related links:
http://www.genzyme.com
http://www.renagel.com
http://www.prnewswire.com/comp/104284.html/
CONTACT:
Media: Dan Quinn, +1-617-768-6849, or
Investors: Sally Curley, +1-617-768-6140, both of Genzyme
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