10/28/2008 - NxStage Reports Positive Interim Quality of Life Results from Landmark FREEDOM Study Comparing Clinical and Economic Benefits of its Daily Home Hemodialysis Therapy with Thrice-Weekly In-Center Treatment
NxStage, a leading manufacturer of innovative dialysis products, today announced positive interim four month results of select health-related quality-of-life (HR-QOL) measures from its ongoing FREEDOM Study - the largest study of its kind to measure the clinical and economic benefits of daily home hemodialysis (DHD) treatment, as compared to conventional, thrice-weekly in-center hemodialysis treatment (CHD), in Medicare patients requiring dialysis therapy. These findings show NxStage's DHD therapy significantly improves patients' HR-QOL as measured by several validated instruments measuring recovery time, depressive symptoms, and overall health-related quality-of-life. Specifically, significant improvements identified in this a priori planned interim analysis included:
-- A reduction in the average time required to resume normal activity from
nearly 8 hours after CHD to just over 1 hour after DHD treatment (change
of 6.6 hours, p < 0.0001). In an average week, this translates into
an additional 17 hours in which normal activities are possible for the
-- A 27% reduction in the Beck Depression Inventory (BDI-II), a score
reflecting depressive symptoms (improving the score from 11.4 to 8.3, p
< 0.0001). Importantly, the average score for DHD patients fell
below 10, which is often viewed as the threshold above which mild
depressive symptoms exist.
-- Improvement in both the physical composite score (from 36.2 to 38.4,
p=0.04) and mental composite score (from 48.2 to 50.7, p=0.03) of an
international standard for health-related quality-of-life assessment
-- Scores for all eight specific health domains improved, and after just
four months, four domains - physical ability to complete daily work or
activities, general health, vitality, and both emotional and physical
ability to participate in social activities - have achieved
statistically significant improvements.
Dr. Frederic Finkelstein, MD, Chief of Nephrology at the Hospital of St. Raphael in New Haven, CT and Clinical Professor of Medicine at Yale University Medical School as well as a co-investigator of the FREEDOM study, will present these four month data and other quality of life data on November 7 during the American Society of Nephrology's annual meeting in Philadelphia. The full abstract of the presentation can be viewed online at http://www.abstracts2view.com/asn/.
"The importance of the impact of therapy on quality of life of patients is important in determining patient decisions on modality selection. The association of quality-of-life with improved patient clinical outcomes is critically important and should influence patient decision making," says Dr. Finkelstein. "These results of our study are therefore significant, and should influence patients to more seriously consider daily home hemodialysis. Although these findings are at four months, longer-term follow up is underway to monitor the impact of DHD on QoL at one year."
Jeff Burbank, CEO of NxStage Medical, Inc. states, "We are delighted that the interim results of the FREEDOM study are becoming available, showing that daily home therapy with the NxStage System One can significantly improve the quality-of-life of our patients compared to patients on conventional in-center dialysis. These results confirm the profound impact on patient's lives we see and hear anecdotally every day from our customers, patients and their families. It's gratifying to see such compelling data emerge from our FREEDOM study, even at this early stage; and we remain confident that FREEDOM is an important catalyst for NxStage in advancing daily home therapy by demonstrating its clear advantages to patients and to society."
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(TM) 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.
Source: Renal Support Network (Renal Support Network News)