Nephrology News & Issues
Will nocturnal hemodialysis get a good night’s sleep?
By Mark E. Neumann
One step forward. Two steps back.
So it seems recently with the fate of nocturnal hemodialysis. But it hasn’t been easy.
New application for the System One
There was certainly good news to report for NxStage Medical last December. The manufacturer of portable hemodialysis machines announced it had won U.S. Food and Drug Administration approval to offer nocturnal dialysis with its System One. "For years, patients and physicians in the United States have been asking for an FDA-cleared home nocturnal hemodialysis option for the improved outcomes and quality of life the modality can deliver," said Brigitte Schiller, MD, chief medical officer of Satellite Healthcare and principal investigator of NxStage's home nocturnal hemodialysis trial. "I, along with my fellow investigators in this trailblazing trial, am pleased that we were able to demonstrate the NxStage System
In February, the NxStage Medical booth at the Annual Dialysis Conference was filled with a bed – naturally – and two nocturnal dialysis patients giving interviews as to why they liked the therapy (see Robby Richardson’s article about nocturnal HD in the May issue of Nephrology News & Issues).
Schiller later told NN&I: “Nocturnal HHD is ideal for patients who want to decrease the time spent on dialysis during the day. ‘Carpe diem’ in the best sense! Diminish the impact dialysis therapy has on their daily life.” For patients doing nocturnal dialysis every other night, Schiller said, “We have seen some patients doing very well with this alternative approach living a full life, the way dialysis therapy was envisioned. However this decision should be made by the prescribing physician and the patient. “
The FHN trial data is back…but why?
That all sounded good, until April 8 when the American Journal of Kidney Diseases published online an article written by Ronco et al. from the Frequent Hemodialysis Network Trial group indicating that results from the nocturnal hemodialysis arm of the FHN trial showed that the mortality rate did not improve among those on nocturnal dialysis compared to those patients in a control group on conventional home hemodialysis. In the paper, the researchers looked at the mortality rate of the 87 individuals in the study who were on 6-times-weekly home nocturnal hemodialysis or conventional 3-times-weekly home hemodialysis for 1 year.
In the nocturnal arm, there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up. In the conventional arm, the numbers of deaths were 1 and 4, respectively.
The authors warned that the results should be interpreted cautiously due to low statistical power for the mortality comparison, attested to the small sample size, and the high rate of hemodialysis prescription changes during the trial.
Alan Kliger, MD, an author of the new study, told Reuters Health the results were
"a great surprise to us…I think it raises the yellow flag to anyone considering these kinds of therapy that we ought to at least think about or consider the possible harm that the therapy may do."
Kliger acknowledges that more research needs to be done to help interpret the results. Others are not so generous. “Now, 2-3 years later, a new analysis of an un-analyzable trial has appeared—this time, on survival,” wrote John Agar, MD, in a blog post on Home Dialysis Central. “An avalanche of papers (probably mostly not read by U.S. researchers) have emerged…that disagree and report better long term survival with home HD regimens. Yet, here, a pitifully small number of patients (a little over 30 in each arm) who were followed for only a median period of 3½ years were reported to show that survival in the nocturnal group was less than in the conventional “centre+home” group. Again, where is the power in this study?”
Did the FNH trial do nocturnal dialysis a disservice by pushing on with an underpowered study? More data is usually better than no data at all. But it would seem that nocturnal hemodialysis deserves a better shake.
Mr. Neumann is the publisher of Nephrology News & Issues magazine, and is based in Scottsdale, Ariz.