Lansoprazole But Not Rofecoxib Reduced Dyspeptic Symptoms of Patients on NSAIDs

Abstract

Purpose: To investigate the efficacy of lansoprazole co-therapy or rofecoxib in the reduction of dyspeptic symptoms in patients taking continuous non-steroidal anti-inflammatory drugs (NSAIDs). Methods: Patients (aged 18 years) who developed dyspepsia (upper abdominal discomfort) while taking daily continuous NSAIDs were screened for the study. Upper endoscopy was performed and patients without baseline peptic ulcers were recruited into the study. They were randomized to receive rofecoxib 25 mg, lansoprazole 30 mg plus diclofenac 100 mg or diclofenac 100mg orally, once daily for 4 weeks. All medications were packed in matched capsules to ensure double-blinding of the study. Dyspeptic symptoms were assessed after 2 weeks and 4 weeks and were graded according to a five-point Likert scale (none, mild, moderate, severe and very severe). The primary endpoint was the proportion of patients who had persistent moderate to severe dyspeptic symptoms. Results: A total of 189 patients were randomized into the study. At the end of 4 weeks, significantly fewer patients receiving diclofenac and lansoprazole had persistent dyspeptic symptoms than patients receiving diclofenac alone (9/64, 14.1% vs 24/62, 37.1%; p0.002). On the other hand, there was no difference in persistent dyspeptic symptoms between patients receiving rofecoxib and patients receiving diclofenac (18/63, 28.6% vs 24/62, 37.1%; p0.26). Conclusion: Lansoprazole co-therapy, but not rofecoxib, effectively controls dyspeptic symptoms associated with long term continuous NSAIDs use.