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| |  Esomeprazole 40 mg Twice Daily in Adult with Moderate-to-Severe Asthma: Presented at UEGW By Chris Berrie COPENHAGEN, DENMARK -- October 21, 2005 -- The proton-pump inhibitor esomeprazole can significantly improve morning peak expiratory flow (amPEF) in patients with persistent moderate-to-severe asthma, and these effects are most pronounced in asthmatics with gastroesophageal reflux disease (GERD) and nocturnal respiratory symptoms, and in patients taking additional long-acting beta-2 agonists (LABAs). These findings, from a multicentre, randomised, double-blind, placebo-controlled study, were presented at the 13th United European Gastroenterology Week (UEGW). Ola Beckman, MD, Study Physician and Clinical Research Physician, Medical Science, AstraZeneca Research and Development Lund, Lund, Sweden, discussed the findings here on October 19th. GERD is a common disease among asthmatics, with about one third of asthmatics also suffering from GERD, and although the mechanism is not understood, acid reflux is a potential asthma trigger, particularly at night," Dr. Beckman explained. As LABAs are often used for difficult-to-control asthma, patients who are treated with these agents might be refractory to asthma medications. Dr. Beckman and colleagues theorised that acid-suppression therapy might improve asthma outcomes. They therefore conducted a proof-of-concept study to determine the effects of esomeprazole in adults with persistent, moderate-to-severe asthma who are regularly treated with anti-inflammatory agents, including inhaled steroids and LABAs. The study design comprised an initial 11-day run-in period before patients were stratified and randomised. Stratification was performed to three groups based on presence of GERD and nocturnal respiratory symptoms (NOC): 201 patients-GERD/+NOC; 219 patients +GERD/–NOC; 350 +GERD/+NOC. Patients within each group were randomised to twice daily placebo or esomeprazole 40 mg for 16 weeks. The researchers monitored for changes in amPEF and conducted a post-hoc subgroup assessment of changes in amPEF for patients taking additional LABAs. Subjects had at least a 6-month history of asthma, forced expiratory volume over 1 second (FEV1) predicted between 55% and 80%, FEV1 reversibility of at least 12%; they also required at least an 80% predicted amPEF. Prior to study entry, they used daily inhaled corticosteroids (ICS) and/or a leukotriene modifier for at least 3 months, and a constant asthma medication for at least 30 days. Baseline characteristics of all patients in the study included: mean age, 44.8 years; male, 31%; predicted FEV1, 66.3%; ICS use, 98%; LABA use, 40%. Also, allowing for the differences due to stratification (e.g. awakenings, only for +NOC groups), the three stratification groups showed similar characteristics. When the esomeprazole-mediated amPEF improvement of 6.3 L/min for all patients was assessed according to patient stratification, the main improvements were seen for the +GERD strata: +GERD/–NOC, 8.3 L/min; +GERD/+NOC, 7.0 L/min; and -GERD/+NOC, 3.6 L/min. However, these effects only reached significance (P < .05) for esomeprazole over placebo when taken as means across the entire treatment period, with the all-patient improvement of 5.6 L/min. The pattern was the same for patients on LABAs, but with all of the amPEF values improved, and with a significant 12.2 L/min improvement reached in the combined LALA-treated patients (P = .017). Overall, adverse events were similar across the groups and mostly mild to moderate in severity. There were no serious adverse events that were considered to be related to the therapy. Dr. Beckman indicated that this esomeprazole regimen significantly improves amPEF in patients with moderate-to-severe asthma, and these benefits are more pronounced in patients with GERD symptoms and nocturnal respiratory symptoms, and in those taking additional LABAs. AstraZeneca provided financial support for this study.
[Study title: Esomeprazole 40 mg Twice Daily for 16 Weeks in Adult with Moderate-to-Severe Asthma: a Randomised, Placebo-Controlled Trial. Abstract OP-G-328]
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