Academic Journal
Main Category: Respiratory / Asthma
Article Date: 13 Dec 2011 - 9:00 PST
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A trial evaluating the intravenous infusion of salbutamol in patients with acute respiratory distress syndrome (ARDS) was stopped after patients receiving the drug had increased mortality and showed no improvement in outcomes. According to the findings of the BALTI-2 study reported online in an article published Online First in The Lancet, the authors Professor Fang Gao Smith and Professor Gavin D Perkins from the University of Warwick in the UK and their team stated that routine treatment of ARDS using this class of drug (ß-2 agonists) cannot be recommended.
Approximately 14% of mechanically ventilated patients suffer from acute respiratory distress syndrome. In addition to a mortality rate ranging from 40-60%, ARDS also causes a significant reduction in survivors' quality of life. According to the earlier BALTI-1 study, intravenous salbutamol reduced extra vascular lung water and plateau airway pressure in ARDS patients. The BALTI-2 study was designed to assess the effects of salbutamol on clinical outcomes, including mortality, in a much larger patient population.
In their randomized controlled trial on 326 intubated and mechanically ventilated patients with onset of ARDS within 72 hours, researchers randomly assigned 162 patients to receive salbutamol and 164 patients to receive placebo for up to 7 days. The patients were aged 16 years or older and both groups lost 1 patient each to follow-up.
The primary outcome was defined as death within 28 days of randomization. However, recruitment was halted due to safety concerns following the second interim analysis. The researchers noted an increased mortality rate in the salbutamol group, with 55 (34%) of 161 patients dying in the salbutamol group compared with 38 (23%) of 163 patients in the placebo group. This translates into an increased death risk of 47% for those in the salbutamol group. The researchers also discovered reduced ventilator-free days and organ failure-free days in the salbutamol group compared with the placebo group.
The researchers state:
"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.Treatment was poorly tolerated because of tachycardia, arrhythmias, and lactic acidosis. These findings were unexpected...Routine use of ß-2 agonist therapy in mechanically ventilated patients with ARDS cannot be recommended."
Dr B Taylor Thompson at the Massachusetts General Hospital, and Harvard Medical School in Boston, MA, USA, says in an associated Comment in the same journal:
"For now, the results of the truncated BALTI-2 trial are sufficient to change practice. ß-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."
Written by Petra Rattue
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Prof Fang Gao Smith et al.
The Lancet, Early Online Publication, 12 December 2011 doi:10.1016/S0140-6736(11)61623-1 Please use one of the following formats to cite this article in your essay, paper or report:
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13 Dec. 2011.
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