A United Kingdom-based clinical trial evaluating the effectiveness of salbutamol in patients with acute respiratory distress syndrome (ARDS) was stopped after it was found that salbutamol increased the risk of death. The [removed]findings[/removed] appear in The Lancet.
In a previous randomized controlled phase 2 trial, researchers found that intravenous infusion of salbutamol for up to 7 days in ARDS patients reduced extravascular lung water and plateau airway pressure. The current study set out to assess the effects of the same intervention on mortality in ARDS patients.
The researchers conducted a multicenter, placebo-controlled, parallel-group, randomized trial at 46 intensive-care units between December 2006 and March 2010. Intubated and mechanically ventilated patients aged 16 and up within 72 hours of ARDS onset were randomly assigned to receive either salbutamol (15 μg/kg ideal body weight per hour) or placebo for up to 7 days. The researchers randomly assigned 162 patients to the salbutamol group and 164 to the placebo group.
The trial was halted after the second interim analysis because of safety concerns. Salbutamol was found to have increased 28-day mortality by 34%, as 55 of the 161 patients in the salbutamol group died, while 38 (23%) of the 163 patients in the placebo group died.
The researchers concluded that early treatment with intravenous salbutamol for ARDS was poorly tolerated and unlikely to benefit such patients. Given that treatment of ARDS patients could worsen outcomes, the researchers do not recommend the routine use of ß-2 agonist treatment in ventilated patients with the disorder.
Source: The Lancet