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New NxStage® FREEDOM Data Shows Continued, Marked Benefits for Patients Using the System One™ for Daily Home Hemodialysis Throughout a 12 Month Period
Date:2/20/2011

from baseline to month 12. (MCS: P=0.01; PCS<0.0001).
  • Seven out of eight individual SF-36 domains – including physical functioning, bodily pain, general health, vitality, mental health and social functioning – showed clinically meaningful improvements.

  • RLS is a distressing neurological disorder characterized by an uncomfortable sensation in the legs, with an irresistible urge to move them. According to various studies, as many as 62% of end stage renal disease (ESRD) patients suffer from RLS which can disrupt their sleep. Additional interim results from the FREEDOM study compared patients' responses to the Medical Outcomes Study (MOS) Sleep Survey and the International RLS Study Group Rating Scale (IRLS) at baseline and 12 months. The 12-month data showed:

  • Overall sleep quality (as measured by the MOS Sleep Problems Indices I and II) significantly improved from baseline to month 12. (Index I: P=0.001; Index II: P<0.001)
  • Significant improvement in three of the individual sleep scales – sleep disturbances, daytime somnolence, and awaken short of breath or with a headache.
  • A sustained improvement in the IRLS global score at four and 12 months compared to baseline (P<0.001).
  • A significant reduction in the percentage of patients who experienced RLS after 12 months (35% vs 26%, p = 0.05). Of those patients experiencing RLS, there was a trend towards a reduction in the percentage of patients with moderate to severe RLS (59% vs 43%, p=0.06).

  • "The FREEDOM study is an important part of our ongoing commitment to enhance access to home hemodialysis," stated Joseph Turk, President North America of NxStage Medical.  "We are delighted that the results continue to reinforce the life-changing benefits of daily home hemodialysis with the NxStage System One."

    These 12-month interim results from the FREEDOM study have been accepted for publication in the Clinical Journal of the Am
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    SOURCE NxStage Medical, Inc.
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