Evaluation of clinical efficacy and tolerability of original and generic etoricoxib in patients with low back pain
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Background. Back pain is one of the most common complaints among adults of all ages and socioeconomic status. According to the World Health Organization, up to 80 % of people experience this condition at least once in their lives. The most common location of pain is the low back. Purpose of the study: to analyze the relationships between the effectiveness, degree of symptom relief and dynamics of acute nonspecific mechanical pain syndrome in the low back in patients with vertebral degenerative diseases, depending on the selected treatment with the original or generic nonsteroidal anti-inflammatory drug. Materials and methods. The study included sixty people with acute low back pain syndrome on the background of vertebral degenerative diseases, including spondylosis, vertebral osteoarthritis, the presence of herniated discs, spinal stenosis, violations of the statics of the spine. All patients were randomly (every other) divided into two groups for treatment with original or generic etoricoxib, a nonsteroidal anti-inflammatory drug that selectively inhibits cyclooxygenase-2. Results. Assessment of the severity of low back pain syndrome on the visual analog scale shows that the patients of both groups at the beginning of the study did not differ statistically significantly. On day 7 of treatment, the difference between the groups was not statistically significant, but on day 14, the pain reduction in group 1 was significantly greater — to the level of 5 points, compared with a reduction to 20 points in group 2 (p < 0.001). Assessing the dynamics of the neuropathic pain component severity using the painDETECT questionnaire shows that at the initial stage, the groups had a statistically significant difference due to a more pronounced (higher) score in group 1 — 15 points versus 11.5 points in group 2. On days 7 and 14, the difference between the groups was not statistically significant (the groups were comparable), but on day 14, the reduction in pain in group 1 was somewhat more significant, to the level of 2 points versus the reduction to the level of 3 points in group 2. The dynamics of the painDETECT indicator was statistically significant in both groups (p < 0.001) from day 0 to day 14 of treatment. No significant difference was found between the groups in terms of central sensitization (as assessed by the central sensitization questionnaire) during separate observation periods (the groups were comparable). However, in group 2, the sensitization index remained practically unchanged during the study period, and in group 1, it decreased gradually, the difference for the period from days 0 to day 14 reached statistical significance (p = 0.029), from 22 to 17.5 points. Conclusions. The choice of the original etoricoxib at a dose of 90 mg for use for 14 days reliably and predictably had better efficacy and tolerability compared to the generic molecule.
Institution: Shupyk National Healthcare University of Ukraine
Language: English
Subfield: Pharmacology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4408685374