HealthDay News — For children with poorly controlled asthma who do not have overt gastroesophageal reflux disease (GERD), treatment with the proton pump inhibitor (PPI) lansoprazole is not associated with improved asthma control, study results indicate.
The mean difference in change in ACQ scores was not clinically meaningful (0.2 units; 95% CI: 0.0-0.3 units) among 149 children without overt GERD assigned to lansoprazole and 157 controls assigned to placebo, Janet T. Holbrook, MPH, PhD, from the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues from the American Lung Association Asthma Clinical Research Centers reported in the Journal of the American Medical Association.
Additionally, there were no significant differences between the two groups in the mean change of forced expiratory volume in one second, asthma-related quality of life or the rate of episodes of poor asthma control. In fact, lansoprazole treatment was associated with more respiratory infections (relative risk=1.3; 95% CI: 1.1-1.6), and higher incidence of sore throat (RR=1.3; 95% CI: 1.1-1.6) and bronchitis (RR=2.2; 95% CI: 0.8-6.1).
“The results of our study indicate that PPI treatment of children with poorly controlled asthma without symptomatic GERD was not an effective therapy for asthma, and there may be significant safety concerns for long-term PPI use in children,” the researchers wrote.
In an accompanying editorial, Fernando D. Martinez, MD, from the Arizona Respiratory Center and the Clinical and Translational Science Institute at the University of Arizona, in Tucson, wrote that the results suggest that GER/GERD does not play a major role in asthma pathogenesis, and praised Holbrook and colleagues for examining “the perils and costs” of anti-GERD therapy overuse.
“The tentative recommendation by the current National Heart, Lung, and Blood Institute guidelines of an empirical trial of GERD therapy in patients with poorly controlled asthma (which was based on the few data available at the time the guidelines were written) is unjustified and should be promptly revised,” Martinez wrote.
He added that the “worrisome and unwarranted” increase in PPI use among children in recent decades is an example of “therapeutic creep,” in which a treatment that has real therapeutic effects in one group of patients is extended to another group in whom efficacy has never been demonstrated.
The potential for serious adverse events with PPI use in this population “should suggest great caution in prescribing PPIs in general pediatric practice,” Martinez wrote.