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NxStage® Reports Significant Interim FREEDOM Study Results
Significant reduction in prescribed anti-hypertensive medications; Lower
than expected mortality
LAWRENCE, Mass., Oct. 27 /PRNewswire/ -- NxStage Medical, Inc. (Nasdaq: NXTM), a
leading manufacturer of innovative dialysis products, today announced the latest
interim results from its ongoing FREEDOM study. The FREEDOM data will be
presented in posters at the American Society of Nephrology (ASN) Renal Week
2009, from October 27th to November 1st in San Diego.
The FREEDOM analysis shows a significant reduction in the need for
anti-hypertensive medications experienced by patients performing daily home
hemodialysis (DHD) therapy with the NxStage System One™, and this reduction was
maintained through the twelve month study period. These interim results from the
FREEDOM study compared the number of anti-hypertensive medications (used to
control blood pressure) that were prescribed at the patients' baseline (when
they were on thrice-weekly, in-center hemodialysis), then at 4-months and
12-months after starting DHD. The study also looked at the number of patients
who were not prescribed anti-hypertensive medications at those intervals. Key
findings include:
-- A nearly 50% reduction in the average number of prescribed anti-hypertensive
medications over 12 months;
-- 33% of patients completely discontinued anti-hypertensive medications; and,
-- 56% of patients experienced a 50% or greater decrease in anti-hypertensive
medications.
Additional FREEDOM data demonstrates a 40% reduction in expected mortality of
patients using daily home hemodialysis (DHD) therapy with the NxStage System One
when compared to patients from the United States Renal Data System (USRDS). The
Standardized Mortality Ratio (SMR), calculated from actual vs. expected deaths,
was 0.6 for DHD patients compared to patients from the USRDS of similar age,
gender, race and primary cause of ESRD.
"In an attempt to see if the decreased morality observed in the study would
remain after statistical adjustment, this analysis utilized a well-established
formula with conservative assumptions to calculate a SMR. Even after correcting
for these variables, patients using daily home hemodialysis therapy with the
System One experienced a significantly lower rate of death when compared to
similar patients from the USRDS database," stated Brent Miller, M.D., an
Investigator involved with the study from Washington University in St Louis.
"This is further clinical evidence that more frequent home hemodialysis can lead
to better clinical outcomes. These results should help energize patients,
nephrologists, healthcare providers and public policy makers to continue to
invest in and advance this therapy to alleviate the burden of dialysis."
Full abstracts can be read online at
www.asn-online.org.
About the FREEDOM Study
The FREEDOM study (Following Rehabilitation, Economics and Everyday-Dialysis
Outcome Measurements) is a multicenter prospective cohort study designed to
measure the clinical and economic benefits of daily home hemodialysis, as
compared to conventional, thrice-weekly in-center hemodialysis. The study will
include up to 500 daily home hemodialysis patients at up to 70 clinical sites,
and a matched cohort control group of 5,000 patients on conventional treatment
chosen at random and derived from the USRDS database. All daily home
hemodialysis patients use the NxStage System One™ as their treatment delivery
system, and all have Medicare as their primary insurance payer. As part of the
study, participants are asked to complete a series of Quality of Life surveys at
the time of enrollment (baseline), at 4 and 12 months, and every 6 months
thereafter as long as they remain in the study. NxStage Medical, Inc. is
sponsoring the FREEDOM study.
About NxStage Medical
NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered
in Lawrence, Massachusetts, USA, that develops, manufactures and markets
innovative products for the treatment of End Stage Renal Disease (ESRD) and
acute kidney failure. For more information on NxStage and its products, please
visit the company's website at
http://www.nxstage.com.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements contained in
this release that are not clearly historical in nature are forward-looking, and
the words "anticipate," "believe," "expect," "estimate," "plan," and similar
expressions are generally intended to identify forward-looking statements.
Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important factors including,
but not limited to: expected growth in home daily hemodialysis and the
anticipated impact and results of the FREEDOM study and other factors that are
discussed in NxStage's filings with the Securities and Exchange Commission,
including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.
NxStage is under no obligation to (and expressly disclaims any such obligation
to) update or alter its forward-looking statements, whether as a result of new
information, future events or otherwise.
Source
Kristen K. Sheppard, Esq.
VP, Investor Relations
978-332-5923
ksheppard @nxstage.com
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