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SAN FRANCISCO — A placebo-controlled trial of omega-3 fatty acid food supplements in patients with acute lung injury or acute respiratory distress syndrome was terminated early when an interim analysis showed that mortality was worse in patients taking the supplements.
Within 60 days, 27% of patients taking omega-3 fatty acids had died, versus 16% of controls, a significant difference, Dr. Michael A. Matthay said at a meeting on critical care medicine sponsored by the University of California, San Francisco. Patients taking the supplements also had fewer ventilator-free days within 28 days (14.6 days versus 17.4 days for controls) and fewer ICU-free days within 28 days (13.9 days versus 16.8 days for controls).
“There were some phase II data indicating that maybe omega-3s would be beneficial in these patients,” said Dr. Matthay of UCSF. “It's a sobering result, for sure.”
The study was part of a trial called EDEN-Omega (Early vs. Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome), which was intended to test both omega-3 supplementation and early versus delayed enteral feeding. Although the data safety and monitoring board terminated the omega-3 arm of the study after 272 patients had been recruited, the enteral feeding arm is ongoing.
Patients had a P/F (arterial oxygen pressure to fraction of inspired oxygen ratio, or PaO2 to FiO2 ratio) below 300 mm Hg, bilateral infiltrates, a requirement for positive pressure ventilation via endotracheal tube, and no clinical evidence of left-sided cardiac failure. Patients were excluded for severe liver disease, severe chronic respiratory disease, and other reasons. Patients were randomized to receive either full-calorie enteral feeding or full-calorie enteral feeding plus twice-daily supplementation with omega-3 fatty acids, gamma linolenic acid, and antioxidants. The supplements were continued for 21 days or until mechanical ventilation was no longer required.
At study termination, the increase in 60-day mortality in the supplement group just reached significance (P = .05). The differences in ventilator-free days and ICU-free days were somewhat more certain (P values of .03 and .02). “One can argue about whether there was enough power here to conclude for sure that [omega-3 fatty acid] was deleterious, but it's certainly strongly in that direction,” Dr. Matthay said.
Dr. Matthay stated that he had no conflicts of interest to declare. The study was supported by the National Heart, Lung, and Blood Institute.
At 60 days, 27% of patients taking omega-3 fatty acids had died, versus 16% of controls. © CLAYTON HANSEN/ISTOCKPHOTO
SAN FRANCISCO — A placebo-controlled trial of omega-3 fatty acid food supplements in patients with acute lung injury or acute respiratory distress syndrome was terminated early when an interim analysis showed that mortality was worse in patients taking the supplements.
Within 60 days, 27% of patients taking omega-3 fatty acids had died, versus 16% of controls, a significant difference, Dr. Michael A. Matthay said at a meeting on critical care medicine sponsored by the University of California, San Francisco. Patients taking the supplements also had fewer ventilator-free days within 28 days (14.6 days versus 17.4 days for controls) and fewer ICU-free days within 28 days (13.9 days versus 16.8 days for controls).
“There were some phase II data indicating that maybe omega-3s would be beneficial in these patients,” said Dr. Matthay of UCSF. “It's a sobering result, for sure.”
The study was part of a trial called EDEN-Omega (Early vs. Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome), which was intended to test both omega-3 supplementation and early versus delayed enteral feeding. Although the data safety and monitoring board terminated the omega-3 arm of the study after 272 patients had been recruited, the enteral feeding arm is ongoing.
Patients had a P/F (arterial oxygen pressure to fraction of inspired oxygen ratio, or PaO2 to FiO2 ratio) below 300 mm Hg, bilateral infiltrates, a requirement for positive pressure ventilation via endotracheal tube, and no clinical evidence of left-sided cardiac failure. Patients were excluded for severe liver disease, severe chronic respiratory disease, and other reasons. Patients were randomized to receive either full-calorie enteral feeding or full-calorie enteral feeding plus twice-daily supplementation with omega-3 fatty acids, gamma linolenic acid, and antioxidants. The supplements were continued for 21 days or until mechanical ventilation was no longer required.
At study termination, the increase in 60-day mortality in the supplement group just reached significance (P = .05). The differences in ventilator-free days and ICU-free days were somewhat more certain (P values of .03 and .02). “One can argue about whether there was enough power here to conclude for sure that [omega-3 fatty acid] was deleterious, but it's certainly strongly in that direction,” Dr. Matthay said.
Dr. Matthay stated that he had no conflicts of interest to declare. The study was supported by the National Heart, Lung, and Blood Institute.
At 60 days, 27% of patients taking omega-3 fatty acids had died, versus 16% of controls. © CLAYTON HANSEN/ISTOCKPHOTO
SAN FRANCISCO — A placebo-controlled trial of omega-3 fatty acid food supplements in patients with acute lung injury or acute respiratory distress syndrome was terminated early when an interim analysis showed that mortality was worse in patients taking the supplements.
Within 60 days, 27% of patients taking omega-3 fatty acids had died, versus 16% of controls, a significant difference, Dr. Michael A. Matthay said at a meeting on critical care medicine sponsored by the University of California, San Francisco. Patients taking the supplements also had fewer ventilator-free days within 28 days (14.6 days versus 17.4 days for controls) and fewer ICU-free days within 28 days (13.9 days versus 16.8 days for controls).
“There were some phase II data indicating that maybe omega-3s would be beneficial in these patients,” said Dr. Matthay of UCSF. “It's a sobering result, for sure.”
The study was part of a trial called EDEN-Omega (Early vs. Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome), which was intended to test both omega-3 supplementation and early versus delayed enteral feeding. Although the data safety and monitoring board terminated the omega-3 arm of the study after 272 patients had been recruited, the enteral feeding arm is ongoing.
Patients had a P/F (arterial oxygen pressure to fraction of inspired oxygen ratio, or PaO2 to FiO2 ratio) below 300 mm Hg, bilateral infiltrates, a requirement for positive pressure ventilation via endotracheal tube, and no clinical evidence of left-sided cardiac failure. Patients were excluded for severe liver disease, severe chronic respiratory disease, and other reasons. Patients were randomized to receive either full-calorie enteral feeding or full-calorie enteral feeding plus twice-daily supplementation with omega-3 fatty acids, gamma linolenic acid, and antioxidants. The supplements were continued for 21 days or until mechanical ventilation was no longer required.
At study termination, the increase in 60-day mortality in the supplement group just reached significance (P = .05). The differences in ventilator-free days and ICU-free days were somewhat more certain (P values of .03 and .02). “One can argue about whether there was enough power here to conclude for sure that [omega-3 fatty acid] was deleterious, but it's certainly strongly in that direction,” Dr. Matthay said.
Dr. Matthay stated that he had no conflicts of interest to declare. The study was supported by the National Heart, Lung, and Blood Institute.
At 60 days, 27% of patients taking omega-3 fatty acids had died, versus 16% of controls. © CLAYTON HANSEN/ISTOCKPHOTO