Therapeutic outcomes in patients with primary osteoarthritis of knee or hip joints in real-world clinical practice according to the data data from FORTE 2.0 observational study
Introduction. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely prescribed to patients with osteoarthritis (OA). Current article discusses the results of a multicenter observational study on the efficacy and safety of naproxen in patients with primary knee or hip OA in real-world clinical practice (FORTE 2.0); these findings expand the understanding of the potential of the drug in symptomatic treatment of these pathological conditions. Objective: To evaluate clinical outcomes and tolerability of naproxen therapy (Nalgesin® Forte) in patients with primary OA of knee or hip joints. Material and methods. The study involved 12,228 patients prescribed naproxen at a dosage of 550 mg once, twice, or three times daily. Clinical efficacy and treatment safety were assessed. Results. In patients with knee or hip joints osteoarthritis (OA) treated with naproxen, a significant reduction was observed in pain (measured on a numerical rating scale), the number of complaints, and the total and sub-scale scores of the Lequesne index (pain and discomfort, maximum pain-free walking distance, and difficulties in daily living) (p <0.01). According to the data of Likert scale questionnaire, the majority of physicians were satisfied with the clinical efficacy (93.89%, p <0.01) and tolerability (97.52%, p <0.01) of the therapy. The majority of patients expressed satisfaction with tolerability (97.25%, p <0.01), ease of administration (97.18%, p <0.01), value for money (93.28%, p <0.01), and pharmacy availability of the drug (96.79%, p <0.01). Adverse reactions were reported in 1.96% of cases. Conclusion. The study demonstrated clinical efficacy and a favorable safety profile of naproxen, as well as high ratings of the therapy; that was established both by healthcare professionals and patients with primary knee or hip joints OA.S.P. Yakupova, E.Yu. Akulinushkina
Keywords
primary osteoarthritis
knee joint
hip joint
gonarthrosis
coxarthrosis
naproxen (Nalgesin® Forte)
References
- Sovaila S, Purcarea A, Neculau A. Chronic pain, a narrative review for the internist in 2024. Rom J Intern Med. 2024;62(2):124–37.
PMID: 38153854. https://doi.org/10.2478/rjim-2023-0035
- Vekov T, Belcheva V, Kolev J. [Analysis of the market of reimbursed medicinal products for outpatient treatment in Bulgaria in 2019. Gen Med. 2020;22(5):33–38 (In Bulgarian)].
- Shetty A, Delanerolle G, Cavalini H, Deng C, Yang X, Boyd A, et al. A systematic review and network meta-analysis of pharmaceutical interventions used to manage chronic pain. Sci Rep. 2024;14(1):1621.
PMID: 38238384. PMCID: PMC10796361. https://doi.org/10.1038/s41598-023-49761-3
- Weisman SM, Brunton S. Efficacy and safety of naproxen for acute pain. J Fam Pract. 2020;69(7 Suppl):S33–S38. PMID: 33104105.
- Vane JR, Botting RM. Anti-inflammatory drugs and their mechanism of action. Inflamm Res. 1998;47 Suppl 2:S78–87.
PMID: 9831328. https://doi.org/10.1007/s000110050284
- Theken KN. Variability in analgesic response to non-steroidal anti-inflammatory drugs. Prostaglandins Other Lipid Mediat. 2018;139:63–70.
PMID: 30393163. https://doi.org/10.1016/j.prostaglandins.2018.10.005
- Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: A randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019;35(12):2149–58.
PMID: 31402718. https://doi.org/10.1080/03007995.2019.1655257
- Chandrasekharan NV, Dai H, Roos KL, Evanson NK, Tomsik J, Elton TS, Simmons DL. COX-3, a cyclooxygenase-1 variant inhibited by acetaminophen and other analgesic/antipyretic drugs: cloning, structure, and expression. Proc Natl Acad Sci U S A. 2002;99(21):13926–31.
PMID: 12242329. PMCID: PMC129799. https://doi.org/10.1073/pnas.162468699
- Hsueh M-F, Bolognesi MP, Wellman SS, Kraus VB. Anti-inflammatory effects of naproxen sodium on human osteoarthritis synovial fluid immune cells. Osteoarthritis Cartilage. 2020;28(5):639–45.
PMID: 32028022. PMCID: PMC7214189. https://doi.org/10.1016/j.joca.2020.01.013
- Solanki N, Patel Y. Drug utilization pattern and drug interaction study of antibiotics prescribed to orthopedic patients in private hospital. Arch Pharm Pract. 2019;10(4):114–17.
- da Costa BR, Pereira TV, Saadat P, Rudnicki M, Iskander SM, Bodmer NS, et al. Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: Network meta-analysis. BMJ. 2021;375:n2321.
PMID: 34642179. PMCID: PMC8506236. https://doi.org/10.1136/bmj.n2321
- Smith TO, Hawker GA, Hunter DJ, March LM, Boers M, Shea BJ, et al. The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis. J Rheumatol. 2019;46(8):981–89.
PMID: 30647185. PMCID: PMC10753652. https://doi.org/10.3899/jrheum.181194
- Flores RH, Hochberg MC. Definition and classification of osteoarthritis. In: Brandt KD, Doherty M, Lohmander LS, eds. Osteoarthritis, 2nd edition. Oxford: Oxford University Press. pp. 20031–38. ISBN: 0-19-850967-7.
- Felson DT. Clinical practice. Osteoarthritis of the knee. N Engl J Med. 2006;354(8):841–48.
PMID: 16495396. https://doi.org/10.1056/NEJMcp051726. Erratum in: N Engl J Med. 2006;354(23):2520.
- Seibert K, Zhang Y, Leahy K, Hauser S, Masferrer J, Perkins W, et al. Pharmacological and biochemical demonstration of the role of cyclooxygenase 2 in inflammation and pain. Proc Natl Acad Sci U S A. 1994;91(25): 12013–17.
PMID: 7991575. PMCID: PMC45366. https://doi.org/10.1073/pnas.91.25.12013
- Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27(11):2635–41. PMID: 11093446.
- Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27(11):1578–89.
PMID: 31278997. https://doi.org/10.1016/j.joca.2019.06.011
- Wu Y, Hao R, Lan B, Mu Y, Dang F, Wang R. The protective effects of naproxen against interleukin-1β (IL-1β)-induced damage in human umbilical vein endothelial cells (HUVECs). Bioengineered. 2021;12(1):5361–72.
PMID: 34427537. PMCID: PMC8806478. https://doi.org/10.1080/21655979.2021.1955560
- Katri A, Dąbrowska A, Lofvall H, Ding M, Karsdal MA, Andreassen KV, et al. Combining naproxen and a dual amylin and calcitonin receptor agonist improves pain and structural outcomes in the collagen-induced arthritis rat model. Arthritis Res Ther. 2019;21(1):68.
PMID: 30795801. PMCID: PMC6387482. https://doi.org/10.1186/s13075-019-1819-9
- Каратеев А.Е., Лила А.М., Мазуров В.И., Насонов Е.Л., Драпкина О.М., Алексеева Л.И. с соавт. Консенсус экспертов 2024: рациональное использование нестероидных противовоспалительных препаратов. Современная ревматология. 2025;19(S1):1–40. [Karateev AE, Lila AM, Mazurov VI, Nasonov EL, Drapkina OM, Alekseeva LI, et al. Expert consensus 2024: Rational use of non-steroidal anti-inflammatory drugs. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2025;19(S1):1–40 (In Russ.)].
EDN: UFNKRC. https://doi.org/10.14412/1996-7012-2025-1S-1-40
About the Authors
Svetlana P. Yakupova, MD, PhD (Medicine), associate professor of the Department of hospital therapy, Kazan State Medical University, chief external specialist in rheumatology of the Ministry of Healthcare of Tatarstan Republic, Kazan, Russian Federation.E-mail: yakupovasp@mail.ru
ORCID: https://orcid.org/0000-0002-8590-4839. Scopus ID: 57188832953. eLibrary SPIN: 9197-7690
Ekaterina Yu. Akulinushkina, MD, PhD (Medicine), rheumatologist of the Department of rheumatology, Republican Clinical Diagnostic Center, Izhevsk, Russian Federation.
E-mail: katewenterly@gmail.com
ORCID: https://orcid.org/0000-0002-9321-431X. Scopus ID: 58706040200. eLibrary SPIN: 3374-7010
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