A study assessing intravenous infusion of the drug salbutamol in patients with acute respiratory distress syndrome was halted because the treatment did not improve patient outcomes and was associated with an increased risk of death, researchers say.
Acute respiratory distress syndrome (ARDS) occurs in about 14% of patients who require being placed on mechanical ventilation. The death rate among patients with ARDS is high—40% to 60%—and survivors have a substantial decrease in their quality of life.
However, "routine use of [beta-2) agonist therapy in mechanically ventilated patients with ARDS cannot be recommended," the researchers wrote in an article published in the online edition of The Lancet.
The British study included 326 patients who received either salbutamol (also known as albuterol) or a placebo within 72 hours of developing ARDS, and the treatment continued for up to seven days. But the study was stopped after 55 (34%) of the 161 patients in the salbutamol group died, compared with 38 (23%) of the 163 patients in the placebo group.
Overall, the death rate was 47% higher in the salbutamol group than in the placebo group, the report indicated.
In addition, patients in the salbutamol group had fewer ventilator-free days and organ failure-free days than those in the placebo group.
"Our findings show that intravenous salbutamol given to patients with early ARDS significantly increased 28-day mortality, and reduced ventilator-free days and duration of organ support compared with those given placebo," explained Fang Gao Smith, MD, and her colleagues from the University of Warwick.
The authors added that the therapy was "poorly tolerated" by patients because it was linked to heart rhythm abnormalities and lactic acidosis (a dangerous buildup of lactic acid in the blood). "These findings were unexpected," the researchers noted.
The findings of the canceled study may be sufficient to change treatment of patients with ARDS, B. Taylor Thompson, MD, of Massachusetts General Hospital and Harvard Medical School, wrote in an accompanying editorial.
"[Beta-2] agonist treatment in patients with ARDS should be limited to the treatment of clinically important reversible airway obstruction and should not be part of routine care," Dr. Thompson recommended.
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