NxStage sent out this press release with the latest news from their FREEDOM study. The emphasis below is mine.
[b]NxStage Reports Sustained Reduction in Clinical Depressive Symptoms for Daily Home Hemodialysis Patients After One Year
Latest results from FREEDOM study show continued, significant relief of depressive symptoms, which have been implicated in higher rates of hospitalization and death among ESRD patients[/b]
LAWRENCE, Mass., March 9, 2009 – NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM study, which show that the significant reduction in depressive symptoms experienced by patients after four months of daily home hemodialysis therapy with the NxStage System One™ continues to be sustained after 12 months on daily home hemodialysis.
Various studies suggest that 20 to 30 percent of patients with end-stage renal disease (ESRD) suffer from clinical depression, the symptoms of which may result in changing sleep habits, lack of appetite, reduced activity level, as well as inability to work and interact in social situations. Moreover, increased presence of depressive symptoms have been linked to significant increases in hospitalization rates and mortality in the dialysis population in large, multinational studies such as the Dialysis Outcomes and Practice Patterns Study (DOPPS).
These interim results from the FREEDOM study compared patients’ baseline and 12-month Beck Depression Inventory (BDI-II), a validated, commonly-used score reflecting depressive symptoms. The 12 month BDI data also focuses on patients with scores greater than 15, which are suggestive of moderate to severe depressive symptoms. Twelve-month BDI data from the FREEDOM study showed:
[b]24.6 percent of patients involved in the study had a BDI score greater than 15 at baseline (in-center therapy) compared to only 17.5 percent of patients at 12 months of daily home hemodialysis therapy.
A nearly 50 percent improvement in mean BDI scores occurred for patients with moderate to severe depressive symptoms.[/b]
Baseline BDI scores did not significantly differ amongst patients who did not complete 12 month follow-up compared to those who did, indicating that there was no biased selection in the compilation of data.
Dr. Frederic Finkelstein, MD, Chief of Nephrology at the Hospital of St. Raphael in New Haven, Conn. and Clinical Professor of Medicine at Yale University Medical School as well as an investigator on the FREEDOM study, presents the 12-month BDI data today during the 29th Annual Dialysis Conference in Houston.
“Depression is a serious, often undiagnosed problem for ESRD patients. The 12-month study results are extremely encouraging because they indicate that for eligible patients, switching to daily home hemodialysis may provide lasting relief of depression symptoms, especially for patients in greatest need—those with moderate to severe depression,” says Dr. Finkelstein. “In turn, addressing the problem of depression in patients could translate into less hospitalizations and improved morbidity and mortality, helping to alleviate the physical and emotional burden on patients and their families, as well as the financial burden on the healthcare system.”
“We are pleased to see FREEDOM’s latest interim results show how daily home therapy with the NxStage System One can lessen the impact of depressive symptoms on patients with ESRD,” says Jeff Burbank, CEO of NxStage Medical, Inc. “FREEDOM continues to reaffirm our mission to bring long-term health and quality of life benefits to more patients, and we look forward to sharing further interim results from FREEDOM as other milestones are reached.”
The 12-month BDI results come out of the ongoing FREEDOM study, the largest study of its kind to measure the clinical and economic benefits of daily home hemodialysis treatment, as compared to conventional, thrice-weekly in-center hemodialysis treatment for patients requiring dialysis therapy. All daily home hemodialysis patients in the FREEDOM study use the NxStage System One as their treatment delivery system, and all have Medicare as their primary insurance payer.
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.
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 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 September 30, 2008. 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.
Kristen K. Sheppard, Esq.
VP, Investor Relations