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| |  Esomeprazole Significantly Improves Work Productivity in Patients With GERD-Related Sleep Disturbances: Presented at DDW By Mary Beth Nierengarten CHICAGO -- June 4, 2009 -- Treating patients with gastro-oesophageal reflux disease (GERD) with esomeprazole reduces work hours lost due to GERD-related sleep disturbances and improves productivity at work and during regular activities, researchers reported here at Digestive Disease Week (DDW) 2009. In a multicentre, placebo-controlled trial, David Johnson, MD, Eastern Virginia Medical School, Norfolk, Virginia, and colleagues randomised 262 adult patients with GERD to 4 weeks of esomeprazole 20 mg once daily (n = 137) or placebo (n = 125) to determine the effect of esomeprazole on work productivity and regular activities in patients with sleep disturbances due to nighttime symptoms of GERD. Results of the study were presented on June 2. Patients were randomised after a 1 to 2 week run-in period in which only rescue medication was allowed. Patients in the study were aged 18-85 years, had heartburn or acid regurgitation for 3 or more months or a history of erosive oesophagitis, had 2 or 3 episodes of nighttime symptoms of GERD per week prior to study enrolment, and had a history of GERD-related sleep disturbance. Investigators used the Work Productivity and Activity Impairment Questionnaire (WPAI-SLEEP-GERD) to assess the effect of GERD-related sleep disturbances on work productivity and regular activities. The 6-item questionnaire was completed by the patients at the time of randomisation to obtain baseline measures and again after 4 weeks at the end of the trial. An analysis of covariance was used to assess changes in WPAI-SLEEP-GERD from baseline to final visit at week 4. Analysis was based on a modified intention-to-treat analysis, which included patients with data on baseline and week-4 measurements who received at least 1 or more doses of esomeprazole, in whom post-treatment data was available, and had moderate to severe nighttime heartburn and GERD-related sleep disturbances on 3 or more of 7 consecutive days during the run-in period. Based on this analysis, 85 patients in the esomeprazole arm and 78 in the placebo arm were analysed. The study found that at baseline, both groups had equivalent number of lost work hours due to GERD-related sleep disturbances. When comparing baseline scores to 4-week scores, the number of lost work hours was significantly reduced in the patients treated with esomeprazole (14.6 hours at baseline to 5.4 hours after 4 weeks of treatment) compared with placebo (15.3 to 10.1 hours), with a least squares mean (LSM) difference of -4.64 (95% confidence interval [CI], -7.20 to -2.07; P = .0005). The size of the effect of GERD-related sleep disturbances on work productivity was also significantly reduced in patients treated with esomeprazole compared with placebo. Based on a scale of 0 to 10, in which 0 represents no effect from GERD-related sleep disturbances and 10 represents not being able to work due to these disturbances, patients treated with esomeprazole reported a 4 at baseline and 1.4 after 4 weeks, whereas patients on placebo reported 4 at baseline and 2.6 after 4 weeks (LSM difference of -1.24; 95% CI, -1.89 to -0.60; P = .0002]). A similar significant reduction in the size of the effect of GERD-related sleep disturbances was found on regular activity, with baseline and 4-week scores of 4.2 to 1.7 in patients treated with esomeprazole and 4.3 to 2.6 in patients on placebo (LSM difference of -1.00; 95% CI, -1.66 to -0.34; P = .0032]). 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: Effect of Esomeprazole on Work Productivity and Regular Daily Activity in Patients With Gastroesophgeal Reflux Disease-Related Sleep Disturbances. Abstract T1068]
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