ESOMEPRAZOLE TREATMENT IN PATIENTS WITH UNINVESTIGATED NON-GERD DYSPEPSIA LEADS TO SIGNIFICANT IMPROVEMENTS IN PRODUCTIVITY WHILE AT WORK AND IN DAILY ACTIVITIES – RESULTS FROM A RANDOMISED, PLACEBO-CONTROLLED CLINICAL STUDY

Author(s)

Wahlqvist P1, Bergenheim K1, Persson T2, Brun J3, Flook N4, Lauritsen K5, Vakil N6, Veldhuyzen van Zanten S7, Talley NJ81AstraZeneca, Mölndal, Sweden; 2 AstraZeneca, Lund, Sweden; 3 AstraZeneca, Södertälje, Sweden; 4 University of Alberta, Edmonton, Alberta, Canada; 5 Odense University Hospital, Odense, Denmark; 6 University of Wisconsin Medical School, Milwaukee, WI, USA; 7 Dalhousie University, Halifax, Nova Scotia, Canada; 8 Mayo Clinic College of Medicine, Rochester, MN, USA

OBJECTIVES: To assess the effect of acid suppression treatment on patient-reported productivity in uninvestigated non-GERD dyspepsia. METHODS: A clinical study aimed to investigate whether response to a 1-week acid suppression trial with esomeprazole is predictive of the response to four to eight weeks of esomeprazole therapy was performed in patients with uninvestigated non-GERD dyspepsia (patients with predominant symptoms of pain or burning in the center of the upper abdomen, and who had not been previously investigated by endoscopy). Disease-specific absence from work, reduced productivity while at work, and reduced productivity while carrying out regular daily activities were obtained by using the Work Productivity and Activity Impairment (WPAI) questionnaire. Patients were randomised to double-blind treatment with esomeprazole 40 mg qd or bid for 7 days, followed by either esomeprazole 40 mg qd or placebo for a further 7 weeks. Symptoms were recorded in a daily diary. RESULTS: Before start of treatment (n=453), employed patients (n=349) reported an average of 2.0 hours absence from work and 19.8% reduced work productivity (=6.6 hours equivalent; percent reduced productivity x hours actually worked) during the past week, as well as 26.8% reduced productivity in daily activities (all patients). In patients who were identified as responders to the 1-week test treatment with esomeprazole, productivity improvements were all statistically significant (except for hours absent from work) for esomeprazole versus placebo after both 4 and 8 weeks of treatment, corresponding to a gain of 2.0 to 3.4 work hours and 5.1 to 5.8 percent-units in daily activities per patient and week (p<0.05). Further analyses of the relationship between treatment response and productivity change supported the validity of these results. CONCLUSION: Effective acid suppression treatment with esomeprazole in patients with uninvestigated non-GERD dyspepsia leads to significant improvements in productivity while at work and in daily activities.

Conference/Value in Health Info

2005-11, ISPOR Europe 2005, Florence, Italy

Value in Health, Vol. 8, No.6 (November/December 2005)

Code

PGI23

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Gastrointestinal Disorders

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