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Caveats: There are many reviews addressing LABA effectiveness and safety. For safety, we focus on a comparison we think reflects a common clinical choice, which is increasing the inhaled steroid vs. adding a LABA. However, other comparisons can be more relevant, for instance, when steroid doses are maximal or when other pharmacologic options with no safety problems (., anticholinergics, leukotriene inhibitors) have been ineffective. 6 , 7
The length of trials complicates interpretation because they typically last just 12 or 26 weeks. The longer the use, the more patients may benefit. The Cochrane authors note that in the few longer-duration studies LABA benefits seemed to diminish or disappear after six months.
Symptom benefits with LABA/steroid therapy were small, typically fewer pumps per day of a rescue inhaler and about 10% more symptom-free days, with no quality-of-life advantage. However, those with more symptoms may benefit more. They may also be at higher risk of a fatal attack, making LABAs tricky. The AUSTRI trial investigators' conclusion that LABA/steroid combinations are safe based on equivalent hospitalization rates is questionable. Hospitalizations are often unaffected by LABAs (see efficacy results above) and may not correlate with asthma deaths. Careful readers may also note that LABAs slightly reduced mild attacks; however, steroid doses were identical in the groups. Had doses been higher in the steroid group, the benefit for mild attacks might have disappeared. This is consistent with the finding that low-risk patients with asthma—the AUSTRI population—experience no meaningful benefit from LABAs. Future studies should focus on medium-risk and high-risk patients with asthma in whom fatal attacks are an uncommon but consistent threat, and for whom the potential benefit may be meaningful.
Finally, picking the most appropriate end point to review for numerical estimates is difficult, which is why we offer a range of values. All-cause mortality is a more patient-centered outcome than asthma-related deaths, but it is often not reported. We chose the Salpeter review as a primary source because it was the most transparent and conservative, and other reviews found the same or nearly identical point estimates.
We have chosen to designate this therapy red (no benefits) according to our rating system because of a small potential benefit of questionable clinical utility (avoiding a brief burst of oral steroids) and the possibility of a fatal harm. We considered black (harms greater than benefits); however, there is uncertainty about these fatal harms, and we hope physicians and patients can discuss these issues, share decisions, and come to their own conclusions.
mg/day inhaled via jet nebulizer either once daily or divided into 2 doses. The maximum manufacturer recommended total dose is 1 mg/day. The National Asthma Education and Prevention Program Expert Panel defines low dose therapy for budesonide inhalation suspension as mg/day, medium dose therapy as 1 mg/day, and high dose therapy as 2 mg/day for children ages 5 to 11 years. Titrate to the lowest effective dose once asthma stability is achieved. Prolonged use of high doses, ., 2 mg/day, may be associated with additional adverse effects.