nnpNeurology, Neuropsychiatry, PsychosomaticsНеврология, нейропсихиатрия, психосоматика2074-27112310-1342"IMA-Press", LLC10.14412/2074-2711-2025-1-102-106nnp-2455Research ArticleREVIEWSОБЗОРЫA new representative of the group of non-steroidal anti-inflammatory drugs in the therapeutic arsenal of a Russian doctor: pelubiprofenНовый представитель группы нестероидных противовоспалительных препаратов в терапевтическом арсенале российского врача: пелубипрофенhttps://orcid.org/0000-0002-1391-0711КаратеевА. Е.KarateevA. E.

115522, Москва, Каширское ш., 34А

34A, Kashirskoe Shosse, Moscow 115522

ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»РоссияV.A. Nasonova Research Institute of RheumatologyRussian Federation202517022025171102106Copyright © Karateev A.E., 20252025Каратеев А.Е.Karateev A.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://nnp.ima-press.net/nnp/article/view/2455

Non-steroidal anti-inflammatory drugs (NSAIDs) are the main class of analgesics used in Russian medical practice to control acute and chronic pain in various conditions. NSAIDs have proven to be effective, easy to use and affordable. On the other hand, NSAIDs are potentially unsafe: the use of these drugs is clearly associated with an increased risk of class-specific complications in the gastrointestinal tract, cardiovascular system and kidneys.

None of the NSAIDs available on the modern pharmaceutical market can be considered ideal in terms of efficacy/safety ratio. This determines the feasibility of developing new drugs from this group.

A new NSAID has now found its way into the therapeutic arsenal of Russian doctors – a member of the 2-arylpropionic acid derivative family, pelubiprofen. This drug, which is structurally similar to ibuprofen, is a moderately selective inhibitor of cyclooxygenase 2 with a very favorable profile of pharmacological properties. Pelubiprofen has been extensively tested in a series of double-blind, randomized and controlled trials comparing it with aceclofenac and celecoxib. These studies have shown the efficacy and low incidence of adverse events in the treatment of non-specific back pain, osteoarthritis and rheumatoid arthritis with the new drug.

Нестероидные противовоспалительные препараты (НПВП) – основной класс анальгетиков, используемых в российской медицинской практике для контроля острой и хронической боли при различных заболеваниях и патологических состояниях. НПВП обладают доказанной эффективностью, они удобны в применении и финансово доступны. С другой стороны, НПВП потенциально небезопасны: применение этих лекарств четко ассоциируется с повышением риска класс-специфических осложнений со стороны желудочно-кишечного тракта, сердечно-сосудистой системы и почек.

Ни один из представленных на современном фармакологическом рынке НПВП не может считаться идеальным по соотношению эффективности и безопасности. Это определяет целесообразность разработки новых препаратов из данной лекарственной группы. Так, в настоящее время в терапевтический арсенал российских врачей вошел новый НПВП – представитель семейства производных 2-арилпропионовой кислоты пелубипрофен. Этот препарат, структурно близкий ибупрофену, является умеренным селективным ингибитором циклооксигеназы-2 с весьма благоприятным профилем фармакологических свойств. Пелубипрофен прошел серьезную проверку в ходе серии двойных слепых рандомизированных контролируемых исследований, в которых он сравнивался с ацеклофенаком и целекоксибом. Эти работы показали эффективность и низкую частоту нежелательных явлений при лечении новым препаратом неспецифической боли в спине, остеоартрита и ревматоидного артрита.

нестероидные противовоспалительные препаратыэффективностьбезопасностьпелубипрофенрандомизированные клинические исследованияnon-steroidal anti-inflammatory drugsefficacysafetypelubiprofenrandomized clinical trialsСтатья спонсируется компанией «Акрихин».The article is sponsored by Akrikhin.ReferencesЯхно НН, редактор. Боль. Практическое руководство. Москва: МЕДпресс-информ; 2022. ISBN 978-5-907504-41-7.Yakhno NN, editor. Pain. Practical guide. Moscow: MEDpress-inform; 2022. ISBN 978-5-907504-41-7 (In Russ.)].Amaechi O, Huffman MM, Featherstone K. Pharmacologic Therapy for Acute Pain. Am Fam Physician. 2021 Jul 1;104(1):63-72.Amaechi O, Huffman MM, Featherstone K. Pharmacologic Therapy for Acute Pain. Am Fam Physician. 2021 Jul 1;104(1):63-72.Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-44.Maharty DC, Hines SC, Brown RB. Chronic Low Back Pain in Adults: Evaluation and Management. Am Fam Physician. 2024 Mar;109(3):233-44.Каратеев АЕ. Болезни костно-мышечной системы в практике 2102 врачей разных специальностей: структура патологии и мнение специалистов об эффективности НПВП (предварительные данные эпидемиологического исследования КОРОНА-2). Consilium medicum. 2013;(9):95-100.Karateev AE. Diseases of the musculoskeletal system in practice of 2102 doctors of different specialties: the structure of pathology and the opinions of experts about the effectiveness of NSAIDs (preliminary data from epidemiological study CORONA-2). Consilium medicum. 2013;(9):95-100 (In Russ.).Yang Z, Mathieson S, Kobayashi S, et al. Prevalence of Nonsteroidal Antiinflammatory Drugs Prescribed for Osteoarthritis: A Systematic Review and Meta-Analysis of Observational Studies. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2345-58. doi: 10.1002/acr.25157. Epub 2023 Jun 19.Yang Z, Mathieson S, Kobayashi S, et al. Prevalence of Nonsteroidal Antiinflammatory Drugs Prescribed for Osteoarthritis: A Systematic Review and Meta-Analysis of Observational Studies. Arthritis Care Res (Hoboken). 2023 Nov;75(11):2345-58. doi: 10.1002/acr.25157. Epub 2023 Jun 19.Coates G, Clewes P, Lohan C, et al. Chronic Low Back Pain with and without Concomitant Osteoarthritis: A Retrospective, Longitudinal Cohort Study of Patients in England. Int J Clin Pract. 2023 Nov 9;2023:5105810. doi: 10.1155/2023/5105810Coates G, Clewes P, Lohan C, et al. Chronic Low Back Pain with and without Concomitant Osteoarthritis: A Retrospective, Longitudinal Cohort Study of Patients in England. Int J Clin Pract. 2023 Nov 9;2023:5105810. doi: 10.1155/2023/5105810Каратеев АЕ, Насонов ЕЛ, Ивашкин ВТ и др. Рациональное использование нестероидных противовоспалительных препаратов. Клинические рекомендации. Научно-практическая ревматология. 2018;56(Прил. 1):1-29. doi: 10.14412/1995-4484-2018-1-29.Karateev AE, Nasonov EL, Ivashkin VT, et al. Rational use of nonsteroidal anti-inflammatory drugs. Clinical guidelines. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2018;56(Suppl. 1):1-29. doi: 10.14412/1995-4484-2018-1-29 (In Russ.).Van Walsem A, Pandhi S, Nixon RM, et al. Relative benefit-risk comparing diclofenac to other traditional non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors in patients with osteoarthritis or rheumatoid arthritis: a network meta-analysis. Arthritis Res Ther. 2015 Mar 19;17(1):66. doi: 10.1186/s13075-015-0554-0Van Walsem A, Pandhi S, Nixon RM, et al. Relative benefit-risk comparing diclofenac to other traditional non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors in patients with osteoarthritis or rheumatoid arthritis: a network meta-analysis. Arthritis Res Ther. 2015 Mar 19;17(1):66. doi: 10.1186/s13075-015-0554-0Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.Krum H, Swergold G, Curtis SP, et al. Factors associated with blood pressure changes in patients receiving diclofenac or etoricoxib: results from the MEDAL study. J Hypertens. 2009 Apr;27(4):886- 93. doi: 10.1097/HJH.0b013e328325d831Krum H, Swergold G, Curtis SP, et al. Factors associated with blood pressure changes in patients receiving diclofenac or etoricoxib: results from the MEDAL study. J Hypertens. 2009 Apr;27(4):886- 93. doi: 10.1097/HJH.0b013e328325d831Каратеев АЕ. Модификация традиционных НПВП как метод повышения их безопасности и удобства применения. Русский медицинский журнал. 2015;7(23):392-6.Karateev AE. Modification of traditional NSAIDs as a method of increasing their safety and ease of use. Russkiy meditsinskiy zhurnal = Russian Medical Journal. 2015;7(23):392-6 (In Russ.).Bülbül B, Kücükgüzel I. Microsomal Prostaglandin E2 Synthase-1 as a New Macromolecular Drug Target in the Prevention of Inflammation and Cancer. Anticancer Agents Med Chem. 2019;19(10):1205-22. doi: 10.2174/1871520619666190227174137Bülbül B, Kücükgüzel I. Microsomal Prostaglandin E2 Synthase-1 as a New Macromolecular Drug Target in the Prevention of Inflammation and Cancer. Anticancer Agents Med Chem. 2019;19(10):1205-22. doi: 10.2174/1871520619666190227174137Rainsford KD. Ibuprofen: from invention to an OTC therapeutic mainstay. Int J Clin Pract Suppl. 2013 Jan;(178):9-20. doi: 10.1111/ijcp.12055Rainsford KD. Ibuprofen: from invention to an OTC therapeutic mainstay. Int J Clin Pract Suppl. 2013 Jan;(178):9-20. doi: 10.1111/ijcp.12055Денисов ЛН, Сидельникова СМ, Павленко ТМ и др. Опыт клинического изучения бруфена в ревматологической практике. В сб.: Результаты клинического изучения лекарственного препарата бруфена. Москва; 1973. С. 27-3.Denisov LN, Sidelnikova SM, Pavlenko TM, et al. The experience of clinical study of brufen in rheumatology practice. In: The results of a clinical study of the drug brufen. Moscow; 1973. P. 27-32 (In Russ.).Moore AR, Derry S, Straube S, et al. Faster, higher, stronger? Evidence for formulation and efficacy for ibuprofen in acute pain. Pain. 2014 Jan;155(1):14-21. doi: 10.1016/j.pain.2013.08.013. Epub 2013 Aug 19.Moore AR, Derry S, Straube S, et al. Faster, higher, stronger? Evidence for formulation and efficacy for ibuprofen in acute pain. Pain. 2014 Jan;155(1):14-21. doi: 10.1016/j.pain.2013.08.013. Epub 2013 Aug 19.Moore RA, Derry S, Aldington D, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults – an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD008659. doi: 10.1002/14651858.CD008659.pub3Moore RA, Derry S, Aldington D, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults – an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD008659. doi: 10.1002/14651858.CD008659.pub3Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Longterm Arthritis Safety Study. JAMA. 2000 Sep 13;284(10):1247-55. doi: 10.1001/jama.284.10.1247Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Longterm Arthritis Safety Study. JAMA. 2000 Sep 13;284(10):1247-55. doi: 10.1001/jama.284.10.1247Farkouh ME, Kirshner H, Harrington RA, et al; TARGET Study Group. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet. 2004 Aug 21-27;364(9435):675-84. doi: 10.1016/S0140-6736(04)16894-3Farkouh ME, Kirshner H, Harrington RA, et al; TARGET Study Group. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet. 2004 Aug 21-27;364(9435):675-84. doi: 10.1016/S0140-6736(04)16894-3Obeid S, Libby P, Husni E, et al. Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 3;8(6):611-21. doi: 10.1093/ehjcvp/pvac015Obeid S, Libby P, Husni E, et al. Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 3;8(6):611-21. doi: 10.1093/ehjcvp/pvac015Shin JS, Baek SR, Sohn SI, et al. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPSinduced inflammatory gene expression via NF-κB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290Shin JS, Baek SR, Sohn SI, et al. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPSinduced inflammatory gene expression via NF-κB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290Pairet M, van Ryn J. Experimental models used to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by non-steroidal anti-inflammatory drugs. Inflamm Res. 1998 Oct;47 Suppl 2:S93-101. doi: 10.1007/s000110050289Pairet M, van Ryn J. Experimental models used to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by non-steroidal anti-inflammatory drugs. Inflamm Res. 1998 Oct;47 Suppl 2:S93-101. doi: 10.1007/s000110050289Shin BJ, Kim TK, Baik JS, Shim DM. Comparison The Safety and The Efficacy between the Group of using Pelubiprofen Tab. and the Group of using Aceclofenac Tab. on Back Pain Patients – Multi Institution, Double Blind, Random Sample. J Korean Soc Spine Surg. 2012 Jun;19(2):38-46. doi: 10.4184/jkss.2012.19.2.38. Epub 2012 Jun 30 (In Korean).Shin BJ, Kim TK, Baik JS, Shim DM. Comparison The Safety and The Efficacy between the Group of using Pelubiprofen Tab. and the Group of using Aceclofenac Tab. on Back Pain Patients – Multi Institution, Double Blind, Random Sample. J Korean Soc Spine Surg. 2012 Jun;19(2):38-46. doi: 10.4184/jkss.2012.19.2.38. Epub 2012 Jun 30 (In Korean).Shin JY, Chang MJ, Kim MK, et al. Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial. PLoS One. 2020 Sep 29;15(9):e0238024. doi: 10.1371/journal.pone.0238024Shin JY, Chang MJ, Kim MK, et al. Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial. PLoS One. 2020 Sep 29;15(9):e0238024. doi: 10.1371/journal.pone.0238024Choi IA, Baek HJ, Cho CS, et al. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, doubleblind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.Choi IA, Baek HJ, Cho CS, et al. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, doubleblind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.

The authors declare that there are no conflicts of interest present.