Efficacy and Safety of Amtolmetin Guacyl in the Management of Knee Osteoarthritis and Associated Dyspepsia in Routine Clinic Setting: AGATA Study
Nasonov Evgeniy Lvovich1, Denisov Lev Nikolaevich1,Tsvetkova Elena Sergeevna1, Otteva Elvira Nikolaevna2, Dubikov Alekzander Ivanovich3, Yakupova Svetlana Petrovna4, Ivanova Olga Nikolaevna5, Korshunov Nikolay Ivanovich6, Vaisberg Alexsandra Rudolfovn7, Abishev Rashad Azadovich8, Tartinov Anton Vladimirovich9, Amit Garg10, Suhas Khandarkar10, Namita Gupta10, Shyam Akku10*
- *Corresponding Author:
- Shyam Akku
Dr Reddy’s Laboratories Ltd., Hyderabad, India
E-mail: [email protected]
Received Date: March 13, 2017; Accepted Date: April 24, 2017; Published Date: April 30, 2017
Citation: Nasonov EL, Denisov LN, Tsvetkova ES, Otteva EN, Dubikov AI et.al. (2017) Efficacy and Safety of Amtolmetin Guacyl in the Management of Knee Osteoarthritis and Associated Dyspepsia in Routine Clinic Setting: AGATA Study. Orthop Muscular Syst 6: 233. doi:10.4172/2161-0533.1000233
Copyright: © 2017 Nasonov EL, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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 ± 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 https://clinicaltrials.gov, number NCT02865161.