The sixth Cochrane Journal Club features our review comparing the safety of combination therapy with regular formoterol and budesonide versus regular salmeterol and fluticasone in adults with asthma. There is a presentation to download, or view on the web, which sets the safety results from this review in the context of previous reviews on the safety of regular formoterol and regular salmeterol in comparison with placebo or when used in combination with an inhaled corticosteroid (ICS) versus the ICS alone. No trials were found directly comparing the safety of regular formoterol and budesonide versus regular salmeterol and fluticasone in children.
We cannot be sure whether or not there is any difference in safety between these combination therapies, or for that matter whether the known risks of regular salmeterol and formoterol are completely abolished by using combination therapy.
The FDA have issued a further safety warning in relation to these products in February 2010 which indicates that salmeterol and formoterol are not to be used without accompanying ICS; the warning particularly highlights safety concerns in children.
It would seem prudent only to continue regular salmeterol or formoterol in those asthmatics that show a clear symptomatic benefit, and the Cates plots in the presentation may help to discuss the long term risks with those patients who do show a clear improvement with salmeterol or formoterol.