Esomeprazole improves quality of life in patients with upper GI symptoms associated with long-term NSAID therapy

Abstract

Purpose: Upper gastrointestinal (G1) symptoms such as abdominal pain and heartburn occur in up to 40% of NSAID users, which significantly impacts on their health-related quality of life (HRQL). This muhicenter, double-blind study compared the effects of esomeprazole and placebo on HRQL in a non-ulcer population with upper Gl symptoms associated with continuous NSAID use. Methods: 608 patients with upper Gi symptoms of at least moderate seventy associated with continuous daily NSAID treatment were randomized to receive esomeprazole 20 mg (n = i95) or 40 mg (n = 206), or placebo (n = 207), once daily for up to 4 weeks. Patients were excluded if they had gastric or duodenal ulcers, were Helicobacter pylori-positive or had erosive esophagitis. HRQL assessments were made at baseline and the last study visit using the Quality of Life in Reflux and Dyspepsia (QOLRAD) instrument, the Gastrointestinal Symptom Rating Scale (GSRS) and the Short Form-36 (SF-36). Results: On the SF-36, the study population scored significantly lower on all dimensions than reference populations of healthy individuals or patients with GERD, and on the dimensions of mental health, role emotional and general health compared with a reference population of patients with arthritis. Esomeprazole significantly improved HRQL on the QOLRAD (increased scores) and GSRS dimensions (decreased scores) a priori specified (Table 1). In addition, both doses of esomeprazole produced greater improvements compared with placebo in the vitality and physical/social functioning QOLRAD dimensions and the diarrhea and constipation GSRS dimensions. Conclusion: Treatment with esomeprazole 40 mg or 20 mg equally improves important aspects of HRQL in patients with upper G[ symptoms associated with long-term NSAID use. Data from the SF-36 confirm that in such patients, in addition to the impact of ~fie underlying condition requiring NSAID therapy, NSAID-induced upper GI symptoms contribute to further worsening of HRQL