Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

A clinical study on the risk and safety profiles of NSAIDs used for osteoporotic fractures in Chinese patients with rheumatoid arthritis

Jianxiang Zhu¹, Zengbing Xia¹, Jikang Min¹, Wenlin Hu¹, Heng Li¹, Chao Mei²

¹Department of Orthopedics, The First People's Hospital of Huzhou, Huzhou, Zhejiang Province 313000, People’s Republic of China; ²Department of Endocrinology, The First People's Hospital of Huzhou, Huzhou, Zhejiang Province 313000, People’s Republic of China.

For correspondence:- Chao Mei Email: chaomei34349@hotmail.com Tel:+8613655335531

Accepted: 3 February 2024 Published: 29 February 2024

Citation: Zhu J, Xia Z, Min J, Hu W, Li H, Mei C. A clinical study on the risk and safety profiles of NSAIDs used for osteoporotic fractures in Chinese patients with rheumatoid arthritis. Trop J Pharm Res 2024; 23(2):437-445 doi: 10.4314/tjpr.v23i2.26

© 2024 The authors.
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Abstract

Purpose: To investigate the risk and safety profile of non-steroidal anti-inflammatory drugs (NSAIDs) for osteoporotic fractures in patients with rheumatoid arthritis (RA).

Methods: 298 RA patients admitted to The First People's Hospital of Huzhou, Huzhou, China from August 2020 to September 2022, were investigated. Patients were assigned to groups based on drugs used viz: control group received anti-rheumatic drugs other than NSAIDs; corticosteroid group received dexamethasone, disease-modifying anti-rheumatic drugs (DMARDs) groups received sulfasalazine, NSAID group received either diclofenac or ibuprofen etc. Each group of patients received the respective treatment frequently for at least 3 years. The primary outcome in this study was the incidence of osteoporotic fracture resulting from fragile bone and deterioration of bone mass.

Results: The incidence of osteoporotic fracture was highest in NSAID group (11.58 %) when compared to 5.44, 4.96, and 2.36 % in the corticosteroid, DMARD and control groups, respectively (p < 0.05). This shows that users of NSAIDs had a 5-fold higher risk of osteoporotic fracture than patients in control group (OR = 1.26 (95 % CI: 1.22 - 1.81)) and 2-fold possibility of osteoporotic fracture when compared to corticosteroid users ((OR = 1.46 (95 % CI: 1.57 - 2.32)) and DMARD users (1.83 (95 % CI: 1.26 - 1.67)).

Conclusion: Rheumatoid arthritis patients on NSAIDs such as celecoxib, diclofenac, ibuprofen, indomethacin, and oxaprozin are at risk of developing osteoporotic fracture. Therefore, NSAIDs must be used with proper counseling in RA patients to minimize the risk of osteoporotic fracture. In future, the study duration will need to be extended to determine the long-term effects and potential changes in bone properties.

Keywords: Rheumatoid arthritis, Osteoporotic fractures, NSAIDs, Corticosteroids, DMARDs