Data Show That Patients Treated with Renagel Achieve Mortality Benefit
CAMBRIDGE, Mass., Jan. 8 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) announced today that findings published in the online
version of Kidney International demonstrate that patients using Renagel
experienced a significantly lower rate of death compared with patients
using calcium-based phosphate binders in a newly completed study.
The results were drawn from the Renagel in New Dialysis study (RIND), a
randomized open-label trial involving 127 patients new to hemodialysis at
five dialysis centers in the United States. All-cause mortality was a
pre-specified secondary endpoint. Results of the primary endpoint -- a
comparison of the degree of coronary artery calcification after 18 months
of treatment -- were published last year and also showed a statistically
significant result in favor of the Renagel-treated population.
According to the study design, patients new to hemodialysis were
randomized to receive either Renagel or a calcium-based phosphate binder,
and were followed for an average of 44 months of treatment. Over the
treatment period, 34 deaths occurred among study participants, including 23
patients who were using calcium-based binders and 11 who were using
Renagel. The difference between the two groups was statistically
significant (p=0.05). After adjustments were made for a range of factors,
including age, race, gender and several baseline medical characteristics,
the difference between the two groups was even greater (p=0.016).
"These results are significant because they show for the first time
that higher levels of coronary artery calcification are associated with a
higher incidence of death in patients on dialysis," said principal
investigator Geoffrey Block, M.D., of Denver Nephrologists, PC, Denver,
Colorado. "Given the high mortality rate seen in patients on dialysis,
control of coronary artery calcification should be an important
consideration for health professionals when determining the type of therapy
that is appropriate for their patients."
Today's findings build on previously published data by establishing a
link between choice of phosphate binders, calcification levels, and
mortality. Earlier results from the RIND study showed that while each type
of phosphate binder helped patients achieve the target levels for
phosphorus and calcium- phosphorus product outlined in the 2003 National
Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI)
guidelines, patients using calcium-based phosphate binders experienced more
rapid and more severe progression of coronary artery calcification than
those using Renagel.
"This study provides important insights for patients and caregivers by
highlighting the benefits of initiating treatment with Renagel from the
time that a patient begins on dialysis," said Richard Moscicki, chief
medical officer, Genzyme.
The Renagel in New Dialysis study was funded by Genzyme.
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. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,000 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.
This press release contains forward-looking statements including,
without limitation, statements about the RIND study's effect on physicians'
treatment of dialysis patients. These statements are subject to risks and
uncertainties that could cause actual results to differ materially from
those projected in these forward-looking statements. These risks and
uncertainties include, among others: additional analysis of the RIND data;
the results of other studies and whether such results are consistent with
the RIND data; the availability and extent of third-party reimbursement for
Renagel(R); and the risks and uncertainties described in reports filed by
Genzyme with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended, including without limitation the
information under the heading "Factors Affecting Future Operating Results"
in the Management's Discussion and Analysis of Financial Condition and
Results of Operations section in Genzyme's Quarterly Report on Form 10-Q
for the period ended September 30, 2006. Genzyme cautions investors not to
place substantial reliance on the forward- looking statements contained in
this press release. These statements speak only as of the date of this
press release, and Genzyme undertakes no obligation to update or revise
these statements.
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 Corporation
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Related links:
http://www.genzyme.com
CONTACT:
media, Dan Quinn, +1-617-768-6849, or
investors, Sally Curley, +1-617-768-6140, both for Genzyme
Corporation
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