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Esomeprazole Benefits Asthma Patients With Gastro-oesophageal Reflux Disease: Presented at ERS

By Evelyn Harvey

VIENNA, Austria -- September 18, 2009 -- Treatment with the proton-pump inhibitor esomeprazole can improve lung function in individuals with asthma and gastro-oesophageal reflux disease (GERD), according to new results from a randomised study presented here at the 19th Annual Congress of the European Respiratory Society (ERS).

Toni Kiljander, MD, Suomen Terveystal Hospital, Turku, Finland, and colleagues presented the first large-scale trial of esomeprazole in asthma patients with GERD on September 14.

GERD affects 10% to 20% of the general population, but prevalence among asthma patients has been estimated at 35% to 82%, raising the possibility that GERD may be a trigger for asthma symptoms. Proton-pump inhibitors such as esomeprazole are the most effective therapeutic agents for GERD. Improvements in peak expiratory flow (PEF) in patients with asthma and GERD were previously noted in a smaller study.

Study subjects (n = 961) were recruited at 155 sites across 13 countries. Subjects were aged 18-70 years and were diagnosed with asthma and symptomatic GERD. Use of an inhaled corticosteroid and a long-acting beta₂-adrenergic agonist daily for >=3 months were also required for inclusion. Additionally, all subjects had experienced >=1 clinically relevant asthma exacerbation during the previous year. Patients were excluded if they needed oral or parenteral corticosteroids <=30 days prerandomisation.

PEF was the primary endpoint. Patients were randomised to 3 groups to receive esomeprazole 40 mg once daily (n = 313), 40 mg twice daily (n = 319), or placebo (n = 328) for 26 weeks after a 2-week run-in. Baseline characteristics were similar between groups, with an average forced expiratory volume in 1 second (FEV₁) at 66% of the predicted value. In addition to lung-function measurements, patients were assessed with a standardised asthma-related quality-of-life questionnaire (AQLQ).

The intent-to-treat analysis population consisted of the 828 patients who completed the study. Esomeprazole at both doses significantly increased FEV₁ between baseline and week 28 compared with placebo -- once daily by 90 mL (P < .05) and twice daily by 120 mL (P < .001). However, when the mean change in FEV₁ was calculated for the 26 weeks treated, only twice-daily esomeprazole showed significant benefit over placebo (70 mL, P < .01). Significant improvement in AQLQ score was also noted with both doses of esomeprazole compared with placebo (P < .001 for once daily; P < .0001 for twice daily). Additionally, morning and evening PEF readings were higher in all patients receiving esomeprazole than in those receiving placebo, but the difference did not reach statistical significance.

No safety concerns were raised during the trial; both once- and twice-daily doses of esomeprazole were well tolerated.

"The improvements in FEV₁ are paralleled by an improvement in asthma-related quality of life," said Dr. Kiljander. "Both outcomes improve continuously throughout long-term treatments." She added, "The clinical implication of these findings is that prolonged acid-suppressive therapy may be required in patients with asthma and symptomatic GERD."

Funding for this study was provided by AstraZeneca R&D.

[Presentation title: The Effect of Esomeprazole 40mg Once or Twice Daily on Asthma Outcome. Abstract P1967]

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