Esomeprazole 40 mg Twice Daily Effective in Adults With Moderate/Severe Asthma: Presented at WCOG
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Esomeprazole 40 mg Twice Daily Effective in Adults With Moderate/Severe Asthma: Presented at WCOG

By Danny Kucharsky

MONTREAL, CANADA -- September 13, 2005 -- Esomeprazole 40 mg twice daily improves morning peak expiratory flow in patients with moderate to severe asthma that requires treatment with both inhaled corticosteroids and long-acting beta2-agonists (LABAs), according to a study presented here on September 12th at the World Congress of Gastroenterology (WCOG).

The study also found that the effects of esomeprazole on peak expiratory flow are more pronounced in patients with both nocturnal respiratory symptoms and gastroesophageal reflux disease (GERD).

Stephen K. Field, MD, FCCP, division of respiratory medicine, University of Calgary Medical School, Calgary, Alberta, Canada, and colleagues investigated whether acid suppression would improve asthma outcomes in adult asthmatics who were being treated with both inhaled corticosteroids and LABAs for asthma control.

According to the investigators, the incidence of GERD is high in asthmatic adults. In addition, they noted, acid reflux may act as a potential asthma trigger and could be a complicating factor in difficult-to-control asthma.

Their subgroup, post-hoc analysis of a double-blind, randomised, parallel-group, multinational placebo-controlled study enrolled adults with persistent, moderate to severe asthma with a forced expiratory volume in 1 second (FEV1) between 55% and 80% of predicted, and morning peak expiratory flow < 80% of predicted. All patients were taking anti-inflammatory asthma medications constantly for more than 30 days.

Patients underwent an 11-day run-in period and were then randomised to receive twice-daily treatment with either esomeprazole 40 mg or placebo for 16 weeks. Patients were divided into 3 groups -- those without GERD but with nocturnal respiratory symptoms, those with GERD but without nocturnal respiratory symptoms, and those with GERD and nocturnal respiratory symptoms.

Of the 770 patients randomised to treatment, 307 (69% female, mean age 44.5 years) were eligible for the subgroup analysis.

The mean increase in morning peak expiratory flow from baseline was significantly higher in the 145 patients treated with esomeprazole than in the 162 patients in the placebo group (a difference of 12.2 L/min, P = .017). The mean increase in evening peak expiratory flow from baseline was also significantly higher with esomeprazole than with placebo (difference of 11.1 L/min, P = .024).

The effect of esomeprazole was greatest in patients with both GERD and nocturnal respiratory symptoms (change in morning peak expiratory flow 14.8 L/min, evening peak expiratory flow 19.0 L/min).

There were no statistically significant differences between esomeprazole and placebo in terms of asthma symptoms, patient-reported FEV1, or use of rescue medication.

Dr. Field concluded that esomeprazole 40 mg twice daily was as well tolerated as placebo in asthmatics receiving inhaled corticosteroids and LABAs.

He noted that similar studies have been conducted but were not controlled or had few patients. "I think this is a good quality study."

The research was supported by AstraZeneca R&D in Sweden

[Presentation title: Effects of Esomeprazole 40 mg Twice-Daily in Adults With Moderate/Severe Asthma Treated Previously With Inhaled Steroids and Long-Acting Beta2-Agonists. Abstract R.0042]

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