CNS Update: Safety of Pregabalin Prolonged Release–Etoricoxib Combination Compared to Etoricoxib for CLBP


eMediNexus    03 February 2023

Currently available treatments for chronic lower back pain (CLBP) do not completely address the nociceptive and neuropathic components of pain. A recent study evaluated the efficacy and safety of a fixed-dose combination (FDC) of low-dose pregabalin prolonged release 75 mg–etoricoxib 60 mg to address both pain components.


This study evaluated efficacy (based on mean change in numeric rating scale [NRS], Roland–Morris disability questionnaire [RDQ], visual analogue scale [VAS], patient global impression of improvement [PGI-I], clinical global impression of improvement [CGI-I] and rescue medication consumption). It also evaluated the safety of FDC in comparison to etoricoxib alone in adult patients with CLBP. The duration of treatment was eight weeks.


Among the 371 patients screened, the study randomized 319 and subjected them to efficacy and safety analysis. Both treatment groups showed no significant difference regarding demography and baseline disease characteristics. The study observed significantly better outcomes with FDC compared to etoricoxib from week four onwards. However, at week 8, both groups showed a significant reduction in mean NRS score from baseline, with the mean NRS score being significantly less in the FDC group compared to the etoricoxib group. 


The FDC showed more effectiveness than etoricoxib regarding a significantly greater reduction in RDQ score and VAS score at week 8. The FDC also performed better in terms of significantly more patients reporting their condition as ‘very much better and clinicians reporting patients’ condition as ‘very much improved. Overall, The patients well tolerated the study medications.


This study shows that the FDC of pregabalin and etoricoxib provides significant benefits in reducing pain and improving functional status compared with etoricoxib alone in patients with CLBP. Pregabalin prolonged release–etoricoxib FDC can be employed for early and sustained pain relief and improving the quality of life in patients with CLBP as it addresses both neuropathic and nociceptive components of pain.


Yeole AB, Sree Ranga Lakshmi G, Selvakumar CJ. et al. Efficacy and Safety of Pregabalin Prolonged Release–Etoricoxib Combination Compared to Etoricoxib for Chronic Low Back Pain: Phase 3, Randomized Study. Pain Ther. 2022. https://doi.org/10.1007/s40122-022-00437-2

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