Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms

• Published in: Drug design, development and therapy Vol. 12; pp. 2775 - 2783
• Main Authors: Scheinberg, Morton, Pott Júnior, Henrique, Macêdo, Eduardo de Almeida, Bocchi de Oliveira, Monalisa Fernanda, Ecclissato, Christina, Amazonas, Roberto Bleuel
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01-01-2018; Taylor & Francis Ltd; Dove Medical Press
• Subjects: Abdomen; Acids; Analgesia; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis; Biocompatibility; Burning; Bursitis; Care and treatment; Combination drug therapy; Comparative analysis; Discomfort; Dosage and administration; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Dyspepsia; Dyspepsia - drug therapy; Esomeprazole; Esomeprazole - administration & dosage; Esomeprazole - therapeutic use; Female; Humans; Magnesium; Male; Medical research; Middle Aged; Naproxen; Naproxen - administration & dosage; Naproxen - therapeutic use; Nausea; Nimesulide; Omeprazole; Original Research; Osteoarthritis; Osteoarticular diseases; Osteoporosis - drug therapy; Pain; Pain - drug therapy; Pain Management; Pantoprazole; Pantoprazole - administration & dosage; Pantoprazole - therapeutic use; Patient compliance; Patients; Questionnaires; Randomized controlled trial; Safety; Signs and symptoms; Sulfonamides - administration & dosage; Sulfonamides - therapeutic use; Tablets; Tablets - administration & dosage; Tablets - therapeutic use; Tendinitis; Ulcers; Universities and colleges; Brazil; naproxen; pantoprazole; esomeprazole; nimesulide; osteoarticular diseases; randomized controlled trial
• ISSN: 1177-8881; 1177-8881
• DOI: 10.2147/DDDT.S172068

This study investigated the safety and efficacy of fixed-dose combination tablets of naproxen/esomeprazole magnesium and nimesulide/pantoprazole to determine if both regimens are equally suited to relieve pain in patients with osteoarticular diseases and dyspeptic symptoms.
Patients were randomly assigned to receive either nimesulide/pantoprazole (100 mg/20 mg) twice daily or naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily for 14 days. The primary endpoint was defined as the mean change in modified Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Secondary endpoints were mean visual analog scale score of dyspeptic symptoms (nausea, abdominal discomfort/pain, epigastric burning, postprandial fullness), mean visual analog scale score of individual dyspeptic symptoms, and individual score of dyspeptic symptoms according to patient diary. This study is registered at ClinicalTrials.gov: NCT01670552.
A total of 490 patients were enrolled and randomized, and 399 completed treatment (naproxen/esomeprazole, n=201; nimesulide/pantoprazole, n=198). The difference in mean change in the modified Western Ontario and McMaster Universities Osteoarthritis Index pain score after 7 days of treatment between the two treatment groups was 2.33 mm (95% CI, -1.22 to 5.89 mm). After 14 days of therapy, the difference was 0.45 mm (95% CI, -3.29 to 4.19 mm). The most common adverse events in the pooled group were abdominal discomfort, abdominal distention, dyspepsia, and nausea, but none of these was deemed to be clinically meaningful.
The present study demonstrated noninferiority of a 14-day regimen with a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for the treatment of osteoarticular pain.