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This trial enrolled 412 patients aged at least 18 years who had asthma that was poorly controlled despite therapy with moderate-to-high doses of inhaled corticosteroids. Eligible patients were those with a history of at least 8 weeks of stable use of an inhaled corticosteroid (dose equivalent to fluticasone 400 mcg/d or higher) and poor asthma control as defined by a score of 1.5 or higher on the Juniper Asthma Control Questionnaire (JACQ) or the occurrence of>1 acute episode of asthma requiring unscheduled medical care during the previous year. Ineligible patients were those who had smoked cigarettes within the previous 6 months or who had a history of at least 10 pack-years of smoking; those with a forced expiratory volume in 1 second (FEV1) of <50% of predicted; those who had undergone surgery for reflux or peptic ulcer; those who had 2 or more episodes/wk of heartburn requiring antacid treatment; and those who had used antireflux medications within the previous month. Enrolled patients underwent a 2- to 8-week run-in period and were then randomized to treatment with either esomeprazole 40 mg twice daily or placebo. Outcome measures were assessed every 4 weeks for a total of 24 weeks. The primary end point was the rate of episodes of poor asthma control, defined as a decrease from baseline of at least 30% in morning peak expiratory flow (PEF) rate on 2 consecutive days; an unscheduled healthcare visit for asthma symptoms; or the need for a course of oral prednisone. Secondary outcomes included the results of spirometry before and after albuterol 180 mcg inhalation and changes in asthma symptom, quality-of-life, and control scores. Ambulatory pH monitoring was used to detect esophageal reflux. Overall, 42% of study patients had an episode of poor asthma control, and 18% of patients required an urgent healthcare visit or course of prednisone to treat asthma symptoms. The rate of episodes of poor asthma control did not differ significantly between esomeprazole- and placebo-treated patients (2.5/person-y vs 2.3/person-y; P=.66). Secondary outcomes, including prebronchodilator FEV1, prebronchodilator forced vital capacity (FVC); postbronchodilator FEV1 peak flow rate; and asthma control, symptom, and quality-of-life scores, also did not differ significantly between groups. Subgroup analyses did not demonstrate significant differences between esomeprazole and placebo treatment in patients with documented gastroesophageal reflux, and no interaction between treatment effect and age, race, sex, body mass index, former smoking status, or asthma severity scores was observed. The authors pointed out that, because this was a superiority trial, they cannot exclude the possibility of a small beneficial or harmful treatment effect with esomeprazole. They concluded, however, that “taken as a whole, the weight of evidence indicates that proton-pump inhibitors should not be routinely prescribed for asthma symptoms if the patient does not have symptoms of gastroesophageal reflux.” Source American Lung Association Asthma Clinical Research Centers; Mastronarde JG, Anthonisen NR, Castro M, et al. Efficacy of esomeprazole for treatment of poorly controlled asthma. N Engl J Med. 2009;360:1487–1499.
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Posted 2009-04-29 14:13:13.0
