Regular Treatment With Formoterol And Inhaled Steroids For Chronic Asthma: Serious Adverse Events

Main Category: Respiratory / Asthma
Article Date: 16 Apr 2009 - 2:00 PDT

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Epidemiological evidence has suggested a link between beta2-agonists and increases in asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta2-agonists are safe when used alone or in conjunction with inhaled corticosteroids.

Extract from Implications for Practice

It is not possible, from the data in this review, to reassure people with asthma that regular use of inhaled corticosteroids with formoterol carries no risk of increasing mortality in comparison to inhaled corticosteroids alone as all four deaths occurred among 6,594 people using both drugs. On the other hand we have found no conclusive evidence of harm and there was only one asthma related death registered during over 3,000 patient years observation on formoterol.

In adults, the decrease in asthma-related serious adverse events on regular formoterol with inhaled corticosteroids was not accompanied by a similar decrease in all cause serious adverse events. In children the number of events was too small to determine whether the increase in all cause non-fatal serious adverse events previously found on regular formoterol alone is abolished by the additional use of inhaled corticosteroids.

Clinical decisions and information for patients regarding regular use of formoterol have to take into account the balance between known symptomatic benefits of formoterol and the degree of uncertainty and concern associated with its potential harmful effects.

(CD006924) by Cates, Lasserson and Jaeschke

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