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Home daily hemodialysis is associated with a number of clinical improvements including reduced fluid overload, improved hypertension, reduced LVH, and improved health-related quality of life – known to be correlated with improved outcomes (morbidity and mortality) in dialysis patients.
NxStage captures basic demographic data and reasons for therapy termination (transfer to other modality, transplant, or death) for all patients who initiate therapy with the NxStage system. On an unadjusted basis, transplantation rates are higher than those seen in PD and HD, and mortality rates have been notably lower.
Survival is the "gold standard" of clinical outcomes. There has not been, and will likely never be, a randomized controlled trial of survival of the daily hemodialysis population due to study size and significant practical enrollment challenges. However, multiple observational, retrospective studies have been published demonstrating 45 to 61% reductions in mortality with home and/or daily dialysis. 1,2,3,4 In addition, a recent study presented at the 2008 Transplant Congress found no difference in survival between nocturnal hemodialysis and standard criteria deceased donor transplantation in a matched study of 177 patients over up to 10 years on therapy.5 Because the NxStage home hemodialysis population differs in age and gender from the overall dialysis population, we routinely analyze survival of the NxStage patient population using a modified standardized mortality ratio (SMR) methodology6, with adjustments for age and gender. In the most recent analysis, data was captured from 2,553 patients from over 300 centers, totaling 1,603 patient-years experience and representing the entire NxStage patient population over a two year period from 2006 to 2007. With an adjusted SMR of 0.495, mortality is 50% lower than expected (p<0.0001) and this reduction was consistent and significant across gender and across all age groupings with significant patient representation.
These results are consistent with those published in the previously referenced observational studies. The NxStage results are unique, however, in the number of patients (2,553 vs. 70-415) and number of centers (>300 vs. 2-5) represented.
NxStage is committed to updating this basic information for public use on a regular basis, similar to the manner in which conventional sources such as the USRDS and the ESRD Networks provide data updates. In addition, the company is committed to supporting innovative and valuable clinical research (such as its FREEDOM7, Nocturnal, and Phosphorus/Calcium Removal studies) and the ultimate publication of this in the scientific and medical literature.
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