#16 Long-Acting Beta-Agonist Inhalers in Asthma: Breathing Evidence Into the Debate?
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- LABA statistically significant increased risk of serious asthma-related event (asthma-related death, intubation or hospitalization):
- 2.8 extra events per 1,000 asthmatics treated with LABA, Number Needed to Harm (NNH)=358.
- Examining risk +/- inhaled steroid.
- LABA alone versus no therapy: Statistically significant increase of 3.63 extra events per 1,000 asthmatics, NNH=276.
- LABA + inhaled steroid versus inhaled steroid: Non-statistically significant 0.25 extra events per 1,000 asthmatics.
- The risk increases with decreasing age (2/1,000 in adults age 18-64 and 15/1,000 in children 4-11).
- No significant difference in serious asthma-related event: LABA/steroid 0.7%, steroid 0.64%.
- Statistically significant reduction in severe asthma exacerbations: LABA/steroid 8.7%, steroid 10.4%, Number Needed to Treat (NNT)=59.
- These findings are supported by four Cochrane reviews7-10 and four other meta-analyses11-14 of LABA safety in asthma:
- Statistically significant increase in non-fatal serious adverse events versus placebo with formoterol (NNH=149 over 16 weeks)7 and salmeterol (NNH=188 over 28 weeks).8
- LABA + inhaled steroid: No statistically significant increase in serious adverse events with formoterol/steroid9 or salmeterol/steroid10 versus steroid alone.
- In one meta-analysis of LABA + inhaled steroid,14 statistical significance reached, but actual difference was very small (NNH>3,334).
- Serious adverse events with LABA are not increased in COPD. LABA alone does not increase mortality in COPD patients, and statistically significantly reduces the risk of COPD exacerbations requiring hospitalization (NNT=56).14