Efficacy and Safety of Amtolmetin Guacyl in the Management of Knee Osteoarthritis and Associated Dyspepsia in Routine Clinic Setting: AGATA Study

Nasonov Evgeniy Lvovich, Denisov Lev Nikolaevich, Tsvetkova Elena Sergeevna, Otteva Elvira Nikolaevna, Dubikov Alekzander Ivanovich, Yakupova Svetlana Petrovna, Ivanova Olga Nikolaevna, Korshunov Nikolay Ivanovich, Vaisberg Alexsandra Rudolfovn, Abishev Rashad Azadovich, Tartinov Anton Vladimirovich, Amit Garg (+3 others)
2017 Orthopedic & Muscular System  
Aim: To evaluate the efficacy and safety of amtolmetin guacyl in the management of osteoarthritis (OA) of knee and associated dyspepsia in routine clinic setting. Methods: In an observational study conducted in the OA outpatients between February 2015 and December 2015, patients with knee joint (KJ) pain ≥ 40 mm on visual analogue scale (VAS) and dyspepsia were enrolled. Amtolmetin guacyl 600 mg tablets twice daily was administered for up to 28 days. Patients were evaluated at baseline, Day 14
more » ... t baseline, Day 14 ± 3, and at Day 28 ± 3 for severity of pain in "target" knee (VAS), Western Ontario and Mc master Universities Arthritis (WOMAC) pain and stiffness, and severity of dyspepsia assessment (SODA). Results: Of the 219 OA patients, approximately 72.5% patients reported decrease in pain in the target KJ by ≥ 40% at the end of the study. Mean pain reduced from 65 mm at baseline to 27 mm at the end of the study. A significant decrease in WOMAC pain score, morning stiffness, and functional limitations were also observed (P<0.001). A significant decrease in severity of dyspepsia assessment (SODA) score and increase in satisfaction was observed. Amtolmetin tolerability was comparatively better than previously used NSAIDS. Conclusion: Amtolmetin guacyl is effective and safe in OA patients with associated dyspepsia and has comparatively better tolerability than other NSAIDS. This trial is registered with http://clinicaltrials.gov, number NCT02865161. Reliability, validity, and responsiveness of severity of Dyspepsia assessment (SODA) in a randomized clinical trial of a COX-2-specific inhibitor and traditional NSAID therapy. Am J Gastroenterol 97: 32-39.
doi:10.4172/2161-0533.1000233 fatcat:mor5kfydszdjjm47pngtafl6fq