Long-Term Treatment With Esomeprazole Associated With Improvements in Asthma in Patients With Symptoms of GERD: Presented at DDW
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Long-Term Treatment With Esomeprazole Associated With Improvements in Asthma in Patients With Symptoms of GERD: Presented at DDW

By Mary Beth Nierengarten

CHICAGO -- June 4, 2009 -- Long-term treatment with esomeprazole improves signs and symptoms of asthma in patients with moderate to severe asthma and symptoms of gastro-oesophageal reflux disease (GERD), report investigators at Digestive Disease Week (DDW).

Previous data have shown that esomeprazole 40 mg twice daily significantly improves peak expiratory flow (PEF) in patients with asthma and GERD.

In the current study, presented here on June 3, esomeprazole administered once and twice daily in patients with moderate to severe asthma and symptoms of GERD showed significant improvements in forced expiratory volume in the first second of expiration (FEV1) from baseline to 26 weeks of treatment compared with placebo.

This is the first major study of a proton pump inhibitor (PPI) to show improvement in FEV1 in this patient population, according to lead author Toni Kiljander, MD, Department of Respiratory Medicine, Suomen Terveystalo Hospital, Turku, Finland.

The multicentre, double-blind, placebo-controlled trial randomised 960 patients with asthma and symptoms of GERD to receive esomeprazole 40 mg once daily (n = 313), esomeprazole 40 mg twice daily (n = 319), or a placebo (n = 328).

Patients were aged 18 to 70 years, had an FEV1 reversibility of >12%, had a mean morning PEF (mPEF) of 50% to 85% of post-bronchodilator PEF, total asthma symptom score of >1, were being treated for asthma, had a history of GERD symptoms, and >1 symptom of GERD.

Patient characteristics were similar among the 3 treatment groups.

The study found a trend toward improved mPEF during the entire 26 weeks for patients treated with esomeprazole compared with placebo, with a difference +3.5 and +5.5 L/min between esomeprazole once daily and esomeprazole twice daily versus placebo, respectively.

Improvements in FEV1 from baseline to 26 weeks of treatment were significantly greater in patients treated with esomeprazole once daily (+0.09 L; 95% confidence interval [CI], 0.03-0.15) and twice daily (+0.12 L; 95% CI, 0.06-0.18) compared with placebo (P = .039 and P < .0001, respectively).

When calculating the mean improvements in FEV1 for the entire 26-week period, however, only esomeprazole given twice daily was significantly greater than placebo (+0.07 L; 95% CI, 0.02-0.12; P < .01).

Significant improvements in asthma were seen with esomeprazole once daily and esomeprazole twice daily based on the Asthma Quality of Life Questionnaire total score, with mean differences of +0.28 (95% CI, 0.12-0.44; P < .001) and +0.41 (95% CI, 0.25-0.57; P < .0001) compared with placebo, respectively.

The investigators also examined the efficacy of these regimens on GERD symptoms. Based on the Reflux Disease Questionnaire, the study found that esomeprazole at both doses was associated with significant improvements in symptoms of GERD compared with placebo (P < .0001); no difference was found between the 2 doses.

“The clinical implication of these findings is that prolonged acid-suppressive therapy may be required in patients with asthma and symptomatic GERD,” he said.

Funding for this study was provided by AstraZeneca.

Digestive Disease Week 2009 is cosponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

[Presentation title: The Effect of Esomeprazole 40 mg Once or Twice Daily on Asthma Outcome: A Double-Blind, Randomized, Placebo-Controlled Trial. Abstract W1828]

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