Lansoprazole Increases Adverse Events Without Improving Asthma Control in Children Without Symptomatic Gastroesophageal Reflux
DynaMed Weekly Update - Volume 7, Issue 5
Gastroesophageal reflux (GER) is common in children with asthma, and The National Heart, Lung and Blood Institute recommends treatment for GER symptoms, especially in children with frequent episodes of nocturnal asthma (Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94). Despite a lack of evidence, proton pump inhibitors (PPIs) are sometimes prescribed for children to improve asthma control, even in the absence of GER symptoms. A new randomized trial investigated the effects of a PPI on asthma outcomes in 306 children with asthma poorly controlled by inhaled corticosteroids. Children (mean age 11 years) were randomized to lansoprazole vs. placebo for 24 weeks. All children were free of GER symptoms. Exclusion criteria included any reflux symptoms requiring treatment, any previous use of PPIs or other reflux medications, or history of antireflux surgery. The lansoprazole dose was 15 mg/day forchildren weighing < 30 kg (66 lbs) and 30 mg/day for children ≥ 30 kg.
The primary outcome was change in score on the Asthma Control Questionnaire (ACQ), which assesses wheezing, shortness of breath, nocturnal symptoms, activity level, use of bronchodilators, and pulmonary function. A change of 0.5 points on the 6-point scale is considered clinically important (reduction indicates improvement). At 24 weeks, there was no significant difference in ACQ scores (mean reduction 0.1 points for lansoprazole vs. 0.2 points for placebo) (level 1 [likely reliable] evidence). Lansoprazole was associated with higher rates of upper respiratory infection (63% vs. 49%, p = 0.02, NNH 7), sore throat (52% vs. 39%, p = 0.02, NNH 7), and bronchitis (7% vs.2% p=0.04, NNH 20). There were no significant differences in asthma-related quality of life, or rate of episodes of poor asthma control.
A group of 115 children had esophageal pH measurements prior to randomization, and 43% were found to have asymptomatic gastroesophageal reflux. There were no significant differences in any asthma outcomes comparing lansoprazole vs. placebo in this subgroup (JAMA 2012 Jan 25;307(4):373).
For more information, see the Asthma in children topic in DynaMed