EFFICACY AND CARDIOVASCULAR SAFETY OF AMTOLMETIN GUACIL IN THE TREATMENT OF PATIENTS WITH ANKYLOSING SPONDYLITIS: FINAL RESULTS OF KORONA STUDY


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The article presents the final results of a prospective, open 12-week study, KORONA study, which was aimed to the evaluation of the efficacy and cardiovascular safety of amtolmetin guacil (AMG) in patients with chronic lower back pain and controlled arterial hypertension. The study included 60 patients aged 18 and older, met with the modified New York criteria for ankylosing spondylitis, with the intensity of back pain of 4.0 and more points according to the numerical rating scale. Patients were divided into 2 groups: the first group (n=41) - patients with controlled arterial hypertension (AH), the second group (n=19) - without arterial hypertension. During first 14 days, patients received AMG at a dose of 180 mg/day, followed by 600 mg/day for 12 weeks. It has been shown that AMG is effective and safe in treating lower back pain in the in the short term. Application of AMG requires monitoring of blood pressure in individuals with high risk of cardiovascular events, especially in the first two weeks of treatment.

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作者简介

O. Gaidukova

SBEI HPE “Saratov State Medical University n.a V.I.Razumovsky" of RMPH

Email: andreyrebrov@yandex.ru
MD, Prof., Head of the Department of Hospital Therapy of Medical Facult Saratov

A. Rebrov

SBEI HPE “Saratov State Medical University n.a V.I.Razumovsky" of RMPH

Saratov

E. Khondkaryan

SBEI HPE “Saratov State Medical University n.a V.I.Razumovsky" of RMPH

Saratov

A. Aparkina

SBEI HPE “Saratov State Medical University n.a V.I.Razumovsky" of RMPH

Saratov

参考

  1. Mandl P., Navarro-Compan V., Terslev L., Aegerter P., van der Heijde D., D'Agostino M.A., et al. EULAR recommendations for the use of imaging in the diagnosis and management of spondyloarthritis in clinical practice. Ann. Rheum. Dis. 2015;74(7):1327-39.
  2. Rohekar S., Chan J., Tse S.M., Haroon N., Chandran V., Bessette L., Mosher D., Flanagan C., Keen K.J., Adams K., Mallinson M., Thorne C., Rahman P., Gladman D.D., Inman R.D. 2014 Update of the Canadian Rheumatology Association/spondyloarthritis research consortium of Canada treatment recommendations for the management of spondyloarthritis. Part I: principles of the management of spondyloarthritis in Canada. J. Rheumatol. 2015; 42(4):654-64.
  3. Poddubnyy D., Conrad K., Haibel H., Syrbe U., Appel H., Braun J., Rudwaleit M., Sieper J. Elevated serum level of the vascular endothelial growth factor predicts radiographic spinal progression in patients with axial spondyloarthritis. Ann. Rheum. Dis. 2014;73(12):2137-43.
  4. Poddubnyy D., Rudwaleit M., Haibel H., Listing J., Marker-Hermann E., Zeidler H., Braun J., Sieper J. Rates and predictors of radiographic spinal progression over two years in patients with early axial spondyloarthritis. Ann. Rheum. Dis. 2011;70(Supp. I3):327.
  5. Poddubnyy D., Haibel H., Listing J., et al. Influence of NSAIDs intake on the radiographic spinal progression over two years in patients with early axial spondyloarthritis. Ann. Rheum. Dis. 2011;70(Supp. I3):128.
  6. Ljungman C., Kahan T., Schiöler L., Wettermark B., Boström K.B., Hasselström J., Manhem K. The Association between Non-Steroidal Anti-Inflammatory Drugs and Blood Pressure Control in Hypertensive Patients and the Relation to Gender. J. Hypertens. 2015;33(Suppl. 1):e92.
  7. Tsai W.C., Ou T.T., Yen J.H., Wu C.C., Tung Y.C. Long-term frequent use of non-steroidal antiinflammatory drugs might protect patients with ankylosing spondylitis from cardiovascular diseases: a nationwide case-control study. PLoS One. 2015;10(5):e0126347.
  8. Layton D., Souverein P.C., Heerdink E.R., Shakir S.A., Egberts A.C. Evaluation of risk profiles for gastrointestinal and cardiovascular adverse effects in nonselective NSAID and COX-2 inhibitor users: a cohort study using pharmacy dispensing data in The Netherlands. Drug. Saf. 2008;31(2):143-58.
  9. Jajic Z., Malaise M., Nekam K., Koo E., Danko K., Kovacs M., Scarpignato C. Gastrointestinal safety of amtolmetin guacyl in comparison with celecoxib in patients with rheumatoid arthritis. Clin. Exp. Rheumatol. 2005;23(6): 809-18.
  10. Coruzzi G., Coppelli G., Spaggiari S., Cavestro G.M., Okolicsanyi L., Lo Giudice P., Pisano C., Tepperman B.L. Gastroprotective effects of amtolmetin guacyl: a new non-steroidal anti-inflammatory drug that activates inducible gastric nitric oxide synthase. Dig. Liver Dis. 2002;34(6):403-410.
  11. Riezzo G., Chiloiro M., Montanaro S. Protective effect of amtolmetin guacyl versus placebo diclofenac and misoprostol in healthy volunteers evaluated as gastric electrical activity in alcohol-induced stomach damage. Dig. Dis. Sci. 2001;46(8):1797-804.
  12. Anwar A, Anwar I.J., Delafontaine P. Elevation of cardiovascular risk by non-steroidal anti-inflammatory drugs. Trends Cardiovasc. Med. 2015.
  13. Гайдукова И.З., Ребров А.П., Апаркина А.В., Хондкарян Э.В. Эффективность и кардиоваскулярная безопасность амтолметин гуацила (найзилата) у больных анкилозирующим спондилитом: промежуточные результаты исследования корона. Эффективная фармакотерапия. 2015;47:4-10.
  14. van der Linden S., Valkenburg H.A., Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984;27(4):361-68.
  15. Garrett S., Jenkinson T., Kennedy L.G., Whitelock H., Gaisford P., Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J. Rheumatol. 1994;21(12):2286-91.
  16. Calin A., Garrett S., Whitelock H., Kennedy L.G., O'Hea J., Mallorie P., Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J. Rheumatol. 1994;21(12):2281-85.
  17. Реброва О.Ю. Статистический анализ медицинских данных. Применение пакета прикладных программ STATISTICA. М., 2002. 312 с.
  18. Sieper J., et al. Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1. Ann. Rheum. Dis. 2014;73(1):101-7.
  19. Song I.H., Poddubnyy D.A., Rudwaleit M., Sieper J. Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum. 2008;58(4):929-38.
  20. Smolen J.S., Braun J., Dougados M., Emery P., Fitzgerald O., Helliwell P., Kavanaugh A., et al. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force. Ann. Rheum. Dis. 2014;73(1):6-16.
  21. Braun J., van den Berg R., Baraliakos X., Boehm H., Burgos-Vargas R., Collantes-Estevez E., et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann. Rheum. Dis. 2011;70(6):896-904.
  22. van der Heijde D., Da Silva J.C., Dougados M., Geher P., van der Horst-Bruinsma I., Juanola X., Olivieri I., Raeman F., Settas L., Sieper J., Szechinski J., Walker D., Boussuge M.P., Wajdula J.S., Paolozzi L., Fatenejad S. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann. Rheum. Dis. 2006;65(12):1572-7.
  23. Гайдукова И.З., Ребров А.П., Нам И.Ф., Кирсанова Н.В. Эторикоксиб в лечении активного сакроилеита у больных аксиальными спондилоартритами, включая анкилозирующий спондилит. Тер. архив. 2014;86(12):42-7.
  24. Гайдукова И.З., Ребров А.П. Эффективность и безопасность различных режимов назначения эторикоксиба у пациентов с аксиальным спондилоартритом, включая анкилозирующий спондилит. Тер. архив. 2015;87(3):77-82.
  25. Поддубный Д.А., Ребров А.П. Традиционные и новые факторы риска развития сердечно-сосудистых заболеваний у больных анкилозирующим спондилитом (болезнь Бехтерева). Тер. архив. 2007; 79(5):20-4.
  26. Han C., Robinson D.W. Jr., Hackett M.V., Paramore L.C., Fraeman K.H., Bala M.V. Cardiovascular disease and risk factors in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J. Rheumatol. 2006;33(11):2167-72.
  27. Ребров А.П., Никитина Н.М. Факторы риска развития сердечно-сосудистых заболеваний у больных ревматоидным артритом. Клин. медицина. 2008;86(2):56-9.
  28. Ребров А.П., Никитина Н.М., Гайдукова И.З. Факторы риска развития сердечно-сосудистых заболеваний при псориатическом и ревматоидном артритах. Тер. архив. 2011;83(5):20-4.
  29. Combe B., Swergold G., McLay J., McCarthy T., Zerbini C., Emery P., Connors L., Kaur A., Curtis S., Laine L., Cannon C.P. Cardiovascular safety and gastrointestinal tolerability of etoricoxib vs diclofenac in a randomized controlled clinical trial (The MEDAL study). Rheumatology (Oxf.). 2009;48(4):425-32.
  30. Fosbol E.L., Folke F., Jacobsen S., Rasmussen J.N., Sorensen R., Schramm T.K., Andersen S.S., Rasmussen S., Poulsen H.E., Kober L., Torp-Pedersen C., Gislason G.H. Cause-specific cardiovascular risk associated with nonsteroidal antiinflammatory drugs among healthy individuals. Circ. Cardiovasc. Qual. Outcomes. 2010;3(4):395-405.

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