Combination Asthma Therapy Compared with Steroids Alone

Salmeterol plus inhaled steroids decreases risk of severe exacerbations but does not alter risk of hospitalization or death

FRIDAY, June 20 (HealthDay News) -- Salmeterol plus inhaled corticosteroids may decrease the risk for severe exacerbations, but does not appear to lower the risk of hospitalization, asthma-related deaths or intubations compared with inhaled corticosteroids alone, according to a new meta-analysis published in the July issue of the Annals of Internal Medicine.

Eric Bateman, M.D., of the University of Cape Town Lung Institute in South Africa, and colleagues conducted a meta-analysis of 66 randomized, controlled trials comparing inhaled corticosteroids plus salmeterol (administered as single device or concomitant administration) with inhaled corticosteroids alone in asthma patients. Data on 20,966 patients with persistent asthma was analyzed, as were blinded case narratives included in the clinical trials.

Participants receiving combination therapy had 35 events, versus 34 events in those who took inhaled corticosteroids-only, the researchers found. The only asthma-related death and the only asthma-related intubation occurred in two patients taking combination therapy; none of the patients receiving steroids-only experienced these events. A sub-analysis of 24 of the trials found combination therapy decreases risk of severe exacerbations, although it did not change the risk for asthma-related hospitalizations.

In an accompanying editorial, Kevin B. Weiss, M.D., of the American Board of Medical Specialties in Evanston, Ill., praises the study method, but cautions that the meta-analysis relied on several small studies involving patients in carefully controlled clinical trials, not real-world situations. However, he notes, "A prospective, real-world, randomized trial that directly addresses the safety of this highly popular combination versus inhaled steroids alone is very unlikely. For all practical purposes, physicians should learn to live with uncertainty about the dangers of this combined therapy."

This study was supported by a grant from GlaxoSmithKline. Several of the authors disclosed financial relationships with GlaxoSmithKline and other pharmaceutical companies. Weiss is a consultant to Merck & Co.

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