medwireNews: Long-term, 24-hour oxygen therapy for severe hypoxia does not significantly reduce the risk for hospitalization or death compared with a 15 hour per day regimen, show the findings of the randomized, controlled REDOX trial.
In addition to comparable rates for this composite endpoint over 1 year, the researchers report similar rates of each individual outcome at the same time point, regardless of whether trial participants received 24-hour or 15-hour oxygen therapy.
“This trial has direct clinical implications,” remark Magnus Ekström (Blekinge Hospital, Karlskrona, Sweden) and co-authors.
“The findings support that there is no clear disadvantage of supplemental oxygen use for 15 hours per day rather than 24 hours per day in terms of reducing the risk of hospitalization or death within 1 year,” they write in The New England Journal of Medicine.
“Therapy-free intervals up to 9 hours per day may substantially reduce the limitations and burdens of long-term oxygen therapy for many patients.”
The team evaluated outcomes in 241 individuals aged a mean of 76 years (59% women) who had severe hypoxia caused most commonly by chronic obstructive pulmonary disease (n=172) or pulmonary fibrosis (n=34).
Participants were eligible for the trial if they had a resting partial pressure of oxygen (PaO2) level below 55 mmHg or an oxyhemoglobin saturation (SpO2, measured by pulse oximetry) lower than 88% while breathing ambient air, or if their PaO2 was below 60 mmHg in ambient conditions and they also had signs of heart failure or polycythemia.
The researchers randomly assigned the cohort to receive oxygen therapy for 24 hours per day (n=117) or 15 hours per day (n=124) for 1 year.
At 1 year, the mean rates of the primary outcome were similar between the treatment regimens, at 124.7 and 124.5 per 100 person–years for the 24-hour and 15-hour oxygen groups, respectively. Therefore, 24-hour treatment was not superior for reduction of hospitalization or death with a hazard ratio of 0.99, and this persisted after adjusting for age and sex, remark Ekström et al.
The time to a first event also did not differ significantly, at a median of 168 and 159 days, respectively.
Secondary analysis revealed that 31.6% of individuals in the 24-hour oxygen treatment group died as did a comparable 27.4% of those in the 15-hours per day group, and 57.3% in each group were hospitalized.
Rates of adverse events did not differ significantly between treatment groups either, report Ekström et al. These included one rib fracture and one extirpation of a colonic polyp in separate individuals in the 24-hour treatment group, both of which were deemed mild.
“The findings from our trial do not support the previous suggestion that long-term oxygen therapy should be used for 24 hours per day in order to prolong survival and confirm the results of observational studies in which long-term oxygen therapy used for 24 hours per day, as compared with 15 hours per day, was not associated with a lower risk of hospitalization or death,” concludes the research team.
Editorialists Darren Taichman (University of Pennsylvania, Philadelphia, USA) and Jeffrey Drazen (Harvard Medical School, Boston, Massachusetts, USA) say the results “provide peace of mind that we can lessen the burden of long-term oxygen therapy – at least somewhat.”
They add: “Shorter treatment durations, together with efforts to improve access to more portable oxygen delivery systems that meet individual needs, should help lighten the load for a patient with hypoxemic lung disease.”
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