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EVALUATION OF THE EFFECTIVENESS OF A NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) SELECTION ALGORITHM BASED ON THE ANALYSIS OF RISK FACTORS FOR DRUG-INDUCED COMPLICATIONS IN REAL CLINICAL PRACTICE: THE RESULTS OF THE ALL-RUSSIAN PRINCIPLE PROJECT (APPLICAT

https://doi.org/10.14412/1995-4484-2017-485-492

Abstract

To enhance the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs), a class of essential medications used to treat acute and chronic pain, is an important and urgent task. For its solution, in 2015 Russian experts provided an NSAID selection algorithm based on the assessment of risk factors (RFs) for drug-induced complications and on the prescription of drugs with the least negative effect on the gastrointestinal tract and cardiovascular system. The PRINCIPLE project was implemented to test the effectiveness of this algorithm.

Subjects and methods. A study group consisted of 439 patients (65% were women and 35% – men; their mean age was 51.3±14.4 years) with severe musculoskeletal pain, who were prescribed NSAIDs by using the above algorithm. The majority of patients were noted to have RFs: gastrointestinal and cardiovascular ones in 62 and 88% of the patients, respectively. Given the RF, eight NSAIDs were used; these were aceclofenac, diclofenac, ibuprofen, ketoprofen, meloxicam, naproxen, nimesulide, and celecoxib, the latter being prescribed most commonly (in 57.4% of cases). NSAID was used in combination with proton pump inhibitors in 30.2% of the patients. The follow-up period was 28 days. The investigators evaluated the efficacy of therapy (pain changes on a 10-point numeric rating scale (NRS)) and the development of adverse events (AE).

 

Results and discussion. Pain was completely relieved in the overwhelming majority (94.9%) of patients. There were no significant differences in the efficacy of different NSAIDs according to NRS scores. The number of AE was minimal and did not differ between different NSAIDs, with the exception of a higher frequency of dyspepsia caused by diclofenac (15.7%). There were no serious complications or therapy discontinuation because of AE.

Conclusion. The use of the NSAID selection algorithm allows for effective and relatively safe therapy with these drugs in real clinical practice.

About the Authors

A. E. Karateev
V.A. Nasonova Research Institute of Rheumatology
Russian Federation

34A, Kashirskoe Shosse, Moscow 115522



A. M. Lila
V.A. Nasonova Research Institute of Rheumatology
Russian Federation
34A, Kashirskoe Shosse, Moscow 115522


M. V. Churyukanov
I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia
Russian Federation

8, Trubetskaya St., Build. 2, Moscow 119991



K. V. Skorobogatykh
University Clinic of Neurology
Russian Federation

2, Molodogvardeiskaya St., Build. 1, Moscow 121467



A. V. Amelin
I.P. Pavlov First Saint Petersburg State Medical University, Ministry of Health of Russia
Russian Federation

6-8, Lev Tolstoy St., Saint Petersburg 197022



D. V. Zakharov
V.M. Bekhterev Saint Petersburg Psychoneurology Research Institute, Ministry of Health of Russia
Russian Federation

3, Bekhterev St., Saint Petersburg 192019



E. A. Trofimov
Scandinavia Medical Clinic
Russian Federation

55a, Liteinyi Prospect, Saint Petersburg 191014



V. A. Shirokov
Ural State Medical University, Ministry of Health of Russia
Russian Federation

3, Repin St., Yekaterinburg 620028



T. V. Popova
City Clinical Hospital Forty
Russian Federation

189, Volgogradskaya St., Yekaterinburg 620102



E. A. Shestel
Regional Clinical Diagnostic Cente
Russian Federation

127, Pushkinskaya St., Rostov-on-Don 344000



Z. A. Goncharova
Rostov State Medical University, Ministry of Health of Russia
Russian Federation

29, Nakhichevansky Lane, Rostovon-Don 344022



A. I. Kulikov
Regional Clinical Hospital Two
Russian Federation

33, First Konnaya Armia St., Rostov-on-Don 344029



O. B. Nesmeyanova
Chelyabinsk Regional Clinical Hospital
Russian Federation

70 Vorovsky St., Chelyabinsk 454092



M. V. Galikhanova
OOO «Preventive Medicine» Multidisciplinary Medical Center
Russian Federation

105/1, Chernyshevsky St., Ufa 450077



References

1. Насонов ЕЛ, Яхно НН, Каратеев АЕ и др. Общие принципы лечения скелетно-мышечной боли: междисциплинарный консенсус. Научно-практическая ревматология. 2016;54(3):247-65 [Nasonov EL, Yakhno NN, Karateev AE, et al. General principles of treatment for musculoskeletal pain: Interdisciplinary consensus. Nauchno- Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2016;54(3):247-65 (In Russ.)]. doi: 10.14412/1995-4484-2016-247-265

2. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti- inflammatory drugs. J Pain Res. 2015 Feb 20;8:105-18. doi: 10.2147/JPR.S75160. eCollection 2015.

3. Каратеев АЕ, Насонов ЕЛ, Яхно НН и др. Клинические рекомендации «Рациональное применение нестероидных противовоспалительных препаратов (НПВП) в клинической практике». Современная ревматология. 2015;(1):4-23 [Karateev AE, Nasonov EL, Yakhno NN, et al. Clinical guidelines «Rational use of nonsteroidal anti- inflammatory drugs (NSAIDs) in clinical practice». Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2015;(1):4-23 (In Russ.)]. doi: 10.14412/1996-7012-2015-1-4-23

4. Pelletier JP, Martel-Pelletier J, Rannou F, Cooper C. Efficacy and safety of oral NSAIDs and analgesics in the management of osteoarthritis: Evidence from real-life setting trials and surveys. Semin Arthritis Rheum. 2016 Feb;45(4 Suppl):S22-7. doi: 10.1016/j.semarthrit.2015.11.009. Epub 2015 Dec 2.

5. Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Feb 14. doi: 10.7326/M16-2367 [Epub ahead of print].

6. Harirforoosh S, Asghar W, Jamali F. Adverse Effects of Nonsteroidal Antiinflammatory Drugs: An Update of Gastrointestinal, Cardiovascular and Renal Complications. J Pharm Pharm Sci (www.cspsCanada.org). 2013;16(5):821-7. doi: 10.18433/J3VW2F

7. Moore A, Makinson G, Li C. Patient-level pooled analysis of adjudicated gastrointestinal outcomes in celecoxib clinical trials: meta-analysis of 51,000 patients enrolled in 52 randomized trials. Arthritis Res Ther. 2013 Jan 8;15(1):R6. doi: 10.1186/ar4134

8. Trelle S, Reichenbach S, Wandel S, et al. Cardiovascular safety of non-steroidal anti- inflammatory drugs: network meta-analysis. BMJ. 2011;342:7086. doi: 10.1136/bmj.c7086

9. Varas-Lorenzo С, Riera-Guardia N, Calingaert B, et al. Myocardial infarction and individual nonsteroidal anti-inflammatory drugs meta-analysis of observational studies. Pharmacoepidemiol Drug Saf. 2013;22:559-70. doi: 10.1002/pds.3437

10. Dubois R, Melmed G, Henning J, Lane L. Guidelines for the appropriate use of non- steroidal anti-inflammatory drugs, cyclooxygenase-2 specific inhibitors and proton pump inhibitors in patients requiring chronic anti-inflammatory therapy. Aliment Pharmacol Ther. 2004;19:197-208. doi: 10.1111/j.0269-2813.2004.01834.x

11. Rostom A, Moayyedi P, Hunt R; Canadian Association of Gastroenterology Consensus Group. Canadian consensus guidelines on long-term nonsteroidal anti-inflammatory drug therapy and the need for gastroprotection: benefits versus risks. Aliment Pharmacol Ther. 2009 Mar 1;29(5):481-96. doi: 10.1111/j.1365-2036.2008.03905.x. Epub 2008 Nov 27.

12. Burmester G, Lanas A, Biasucci L, et al. The appropriate use of non-steroidal anti- inflammatory drugs in rheumatic disease: opinions of a multidisciplinary European expert panel. Ann Rheum Dis. 2011;70(5):818-22. doi: 10.1136/ard.2010.128660

13. Lanas A, Benito P, Alonso J, et al. Safe prescription recommendations for non steroidal anti-inflammatory drugs: consensus document ellaborated by nominated experts of three scientific associations (SER-SEC-AEG). Reumatol Clin. 2014 Mar-Apr;10(2):68- 84. doi: 10.1016/j.reuma.2013.10.004. Epub 2014 Jan 24.

14. Conroy RM, Pyorala K, Fitzgerald AP, et al. SCORE project group. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J. 2003 Jun;24(11):987-1003. doi: 10.1016/S0195-668X(03)00114-3

15. Lanas A, Tornero J, Zamorano J. Assessment of gastrointestinal and cardiovascular risk in patients with osteoarthritis who require NSAIDs: the LOGICA study. Ann Rheum Dis. 2010;69(8):1453-8. doi: 10.1136/ard.2009.123166

16. Scarpignato C, Lanas A, Blandizzi C, et al. Safe prescribing of non-steroidal anti- inflammatory drugs in patients with osteoarthritis – an expert consensus addressing benefits as well as gastrointestinal and cardiovascular risks. BMC Med. 2015;13:55. doi: 10.1186/s12916-015-0285-8

17. Насонов ЕЛ. Анальгетическая терапия в ревматологии: путешествие между Сциллой и Харибдой. Клиническая фармакология и терапия. 2003;12(1):64-9 [Nasonov EL. Analgesic therapy in rheumatology: a journey between Scylla and Charybdis. Klinicheskaya Farmakologiya i Terapiya. 2003;12(1):64-9 (In Russ.)].

18. Chan F, Lanas A, Scheiman J, et al. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010;376:173-9. doi: 10.1016/S0140-6736(10)60673-3

19. Castellsague J, Riera-Guardia N, Calingaert B, et al. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012;35(12):1127-46. doi: 10.1007/BF03261999

20. Nissen S, Yeomans N, Solomon D, et al. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 13 Nov 2016. doi: 10.1056/NEJMoa1611593

21. Stam W, Jansen J, Taylor S. Efficacy of etoricoxib, celecoxib, lumiracoxib, non-selective NSAIDs, and acetaminophen in osteoarthritis: a mixed treatment comparison. Open Rheumatol J. 2012;6:6-20. doi: 10.2174/1874312901206010006. Epub 2012 Apr 3.

22. Каратеев АЕ. Факторы, влияющие на эффективность обезболивающей терапии. Эффективная фармакотерапия. Неврология и психиатрия. 2013;47(5):46-53 [Karateev AE. Factors affecting the effectiveness of analgesic therapy. Effektivnaya Farmakoterapiya. Nevrologiya i Psikhiatriya. 2013;47(5):46-53 (In Russ.)].

23. Dougados M, Le Henanff A, Logeart I, Ravaud P. Short-term efficacy of rofecoxib and diclofenac in acute shoulder pain: a placebocontrolled randomized trial. PLoS Clin Trials. 2007 Mar 9;2(3):e9. doi: 10.1371/journal.pctr.0020009

24. Gottesdiener K, Schnitzer T, Fisher C, et al. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology. 2002;41:1052-61. doi: 10.1093/rheumatology/41.9.1052

25. Moore RA, Derry S, McQuay HJ. Discontinuation rates in clinical trials in musculoskeletal pain: meta-analysis from etoricoxib clinical trial reports. Arthritis Res Ther. 2008;10(3):R53. doi: 10.1186/ar2422. Epub 2008 May 8.

26. Da Costa BR, Reichenbach S, Keller N, et al. Effectiveness of non-steroidal anti- inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016 May 21;387(10033):2093-105. doi: 10.1016/S0140-6736(16)30002-2. Epub 2016 Mar 18.

27. Mallen SR, Essex MN, Zhang R. Gastrointestinal tolerability of NSAIDs in elderly patients: a pooled analysis of 21 randomized clinical trials with celecoxib and nonselective NSAIDs. Curr Med Res Opin. 2011 Jul;27(7):1359-66. doi: 10.1185/03007995.2011.581274. Epub 2011 May 12.

28. Lanas A. A review of the gastrointestinal safety data – a gastroenterologist's perspective. Rheumatology (Oxford). 2010 May;49 Suppl 2:ii3-10. doi: 10.1093/rheumatology/keq058


Review

For citations:


Karateev A.E., Lila A.M., Churyukanov M.V., Skorobogatykh K.V., Amelin A.V., Zakharov D.V., Trofimov E.A., Shirokov V.A., Popova T.V., Shestel E.A., Goncharova Z.A., Kulikov A.I., Nesmeyanova O.B., Galikhanova M.V. EVALUATION OF THE EFFECTIVENESS OF A NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) SELECTION ALGORITHM BASED ON THE ANALYSIS OF RISK FACTORS FOR DRUG-INDUCED COMPLICATIONS IN REAL CLINICAL PRACTICE: THE RESULTS OF THE ALL-RUSSIAN PRINCIPLE PROJECT (APPLICAT. Rheumatology Science and Practice. 2017;55(5):485-492. (In Russ.) https://doi.org/10.14412/1995-4484-2017-485-492

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ISSN 1995-4484 (Print)
ISSN 1995-4492 (Online)