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Efficacy and safety of amtolmetin guacil in the therapy of osteoarthritis and associated dyspepsia in routine clinical practice: agatha

https://doi.org/10.21518/2079-701X-2018-9-56-60

Abstract

Objective. To assess the efficacy and safety of amtolmetin guacil (AMG) in patients with knee joint osteoarthritis (KJOA) and associated dyspepsia in real clinical practice.

Methods. 220 patients with KJOA with severe pain syndrome in KJ ≥ 40 mm in VAS and dyspepsia were included in the observation study. AMG was administered at a dose of 600 mg twice daily for 28 days. Patients had three visits: before starting treatment, on Day 14 ± 3 (visit 2), on Day 28 ± 3 (final visit) to assess the pain dynamics (according to VAS), stiffness and functional activity according to WOMAC index, general health assessment (according to VAS) and a quantitative assessment of dyspepsia (SODA index).

Results. Of 219 patients, about 72.5% reported pain reduction from 65 to 27 mm at the end of the study. All indicators of three scales of the WOMAC index decreased statistically significant (р<0,001). There was also a significant decrease of non-pain and pain signs of dyspepsia and an increase in the “treatment satisfaction” index (р<0,001). The patients showed better tolerability of AMG than that of previously taken NSAIDs.

Conclusion. AMG proved to be an effective drug with good tolerability and positive effect on associated dyspepsia.

About the Authors

L. N. Denisov
V.A.Nasonova Research Institute of Rheumatology
Russian Federation

Moscow



E. S. Tsvetkova
V.A.Nasonova Research Institute of Rheumatology
Russian Federation

Moscow



E. N. Otteva
Regional Clinical Hospital No.1, Institute for Advanced Postgraduate Training of Public Health Workers
Russian Federation

Khabarovsk



A. N. Dubikov
Pacific State Medical University of the Ministry of Health of Russia
Russian Federation

Vladivostok



S. P. Yakupova
Kazan State Medical University of the Ministry of Health of Russia
Russian Federation


O. N. Ivanova
Voronezh Region Clinical Hospital No.1
Russian Federation


N. I. Korshunov
Yaroslavl State Medical Academy
Russian Federation


А. P. Vaisberg
Nizhny Novgorod Medical University of the Ministry of Health of Russia
Russian Federation


R. A. Abyshev
City Polyclinic No.100 in Nevsky District of St. Petersburg
Russian Federation


А. V. Tartynov
Regional Medical Diagnostic Center
Russian Federation

Novosibirsk



E. L. Nasonov
V.A.Nasonova Research Institute of Rheumatology; I.M.Sechenov First Moscow State Medical University of the Ministry of Health of Russia
Russian Federation


References

1. Glyn-Jones S, Palmer AJR, Agricola R, Vincent TL, Weinsans H, Carr A. Osteoarthritis. Lancet, 2015, 386: 376-387, doi: 10/1016/S01496736(14)60802-3.

2. Erdes ShF, Folomeeva OM. Rheumatic diseases and disability of adult population of the Russian Federation. Nauchno-Prakticheskaya Revmatologiya 2007, 4: 4-10. doi: 10.14412/1995-4484-2007-4-9

3. Folomeeva OM, Galushko EA, Erdes ShF. The prevalence of rheumatic diseases in the adult population of Russia and the United States. NauchnoPrakticheskaya Revmatologiya, 2008, 46 (4): 4-13. doi: 10.14412/1995-4484-2008-529.

4. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken), 2012, 64: 465–74. doi: 10/1002/acr.21596.

5. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage, 2014, 22: 363–88. doi: 10.1016/j.joca.2014.01.003.

6. Scarpifnato C, Lanas A, Blandizzi C, Lems WF, Hermann M, Hunt RH for International NSAIS Consensus Group. Safe rescribing of non-steroidal anti-inflammatory drugs in patients with osteoarthritis -- an expert consensus addressing benefits as well as gastrointestinal and cardiovascular risk. BMC Medicine, 2015, 13: 55. doi: 10.1186/s12916-015-0285-8.

7. Rabeneck L, Wristers K, Goldstein JL. 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. The Amer J Gastroenterol, 2002, 97: 32–9. doi: 10.1111/j/1572-0241.2002.05419.x.

8. Ofman JJ, MacLean CH, Straus WL, et al. Metaanalysis of dyspepsia and non-steroidal antiinflammatory drugs. Arthritis Rheum, 2003, 49: 508-18. doi:10.1002/art.11192.

9. Spiegel BMR, Farid M, Gralnek IM, Dulai GS, Kanwal F. Comparing rates of dyspepsia with coxib versus NSAID+PPI combination therapy: a systematic review and meta-analysis. American Journal of Medicine, 2006, 119(5): 448.e27-36.

10. Jajić Z, Malaise M, Nekam K, et al. Gastrointestinal safety of amtolmetin guacyl in comparison with celecoxib in patients with rheumatoid arthritis. Clin Exp Rheumatol, 2005, 23: 809–818.

11. Lazzaroni M, Anderloni A, Bianchi Porro G. The effects on gastroduodenal mucosa of a new nonsteroidal anti-inflammatory drug, amtolmetin-guacyl, versus piroxicam in healthy volunteers: a short-term, double blind, endoscopically controlled study. Euro J Gastroenterol Hepatol, 2001, 13: 833–39. doi: 10.1097/00042737200107000-00012.

12. Garg A, Shoeb A, Moodahadu LS et al. Amtolmetin: a reaprasal of NSAID with gastroprotection. Arthritis, 2016, Article ID: 7103705. doi10.1155/2016/7103705.Epub 2016 Mar 22.

13. Koc E, Ku cu kgu zel SG. Medicinal chemistry and anti-inflammatory activity of nitric oxidereleasing NSAI drugs. MedChemistry, 2009, 9: 611-9, doi: 10,2174/138955709788167556.

14. Tsvetkova ES, Denisov LN, Otteva EN. Open multicenter observational study of the efficacy, tolerability and safety of the nonsteroidal anti-inflammatory drug amtolmetin guacil in patients with knee joint osteoarthritis and dyspepsia. Nauchno-Prakticheskaya Revmatologiya, 2016, 54: 654-9.

15. Nasonov EL, Denisov LN, Tsvetkova ES et al. Efficacy and safety of amtolmetin guacyl in the management of knee osteoarthritis and associated dyspepsia in routine clinic setting: AGATA study. Orthopedic @ Muscular System: Current Research, 2017, 6(2): 33-8.

16. Wallace JL. NSAID gastropathy and enteropathy: distinct pathogenesis likely necessitates distinct prevention strategy. Brit J Pharmacol, 2012, 165: 67-74, doi: 10.1111/j.1476-5381,2011.01500.x.

17. Enck P, Dubois D, Marquis P. Quality of life in patients with upper gastrointestinal symptoms: results from the Domestic/International Gastroenterology Surveillance Study (DIGEST). Scand J Gastroenterol, 1999, 231(Suppl): 48–54. doi: 10.1080/003655299750025264.


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For citations:


Denisov LN, Tsvetkova ES, Otteva EN, Dubikov AN, Yakupova SP, Ivanova ON, Korshunov NI, Vaisberg АP, Abyshev RA, Tartynov АV, Nasonov EL. Efficacy and safety of amtolmetin guacil in the therapy of osteoarthritis and associated dyspepsia in routine clinical practice: agatha. Meditsinskiy sovet = Medical Council. 2018;(9):56-60. (In Russ.) https://doi.org/10.21518/2079-701X-2018-9-56-60

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