Among patients with chronic low back pain reporting severe pain, treatment with a fixed-dose combination of prolonged-release pregabalin and etoricoxib was found to be associated with greater reduction in pain and improvement in functional status compared with etoricoxib monotherapy. These findings, from a randomized, open-label, phase 3 trial, were published in Pain Therapy.
Patients (N=319) with chronic low back pain were recruited at 12 sites in India between 2018 and 2019. Randomization occurred in a 1:1 ratio, and patients received either a once-daily fixed-dose combination of prolonged-release pregabalin 75 mg and etoricoxib 60 mg (n=160) or monotherapy with etoricoxib 60 mg (n=159) for 8 weeks. The primary efficacy outcome was the change in numeric rating scale (NRS) scores for pain from study enrollment to week 8.
The mean ages of the fixed-dose combination therapy and monotherapy cohorts were 43.13±11.59 and 45.26±10.55 years, respectively; mean body mass index (BMI) values were 25.65±3.90 and 26.43±4.54 kg/m2, 63.8% and 67.3% had a herniated disc, 18.8% and 18.9% had spinal stenosis, 17.5% and 13.8% had both a herniated disc and spinal stenosis, 73.1% and 71.7% reported experiencing sharp and shooting pain below the knee, and mean NRS pain scores at baseline were 7.26±1.11 and 7.22±1.02 points, respectively.
Adherence to treatment was high in both study arms, with 96.25% of individuals in the fixed-dose combination cohort and 96.23% of patients in the monotherapy arm demonstrating at least 80% adherence to treatment and completing all evaluations.
Compared with recipients of etoricoxib monotherapy, recipients of the fixed-dose combination pregabalin and etoricoxib regimen reported a greater change from baseline in NRS pain scores at weeks 4 (mean change, -2.24 vs -1.57 points; P <.0001) and 8 (mean change, -4.00 vs -2.92; P <.0001).
Baseline Roland-Morris disability questionnaire scores were comparable among the fixed-dose combination and monotherapy cohorts (14.63±4.46 and 14.57±3.93, respectively). Changes from baseline to weeks 4 (mean change, -5.42 vs -3.96; P <.0001) and 8 (mean change, -9.28 vs -6.78; P <.0001) were significantly higher among those receiving the fixed-dose combination treatment compared with those receiving monotherapy.
Eleven treatment-emergent adverse events were reported by participants in both study cohorts. Events experienced by those receiving the fixed-dose combination therapy pyrexia, rhinitis, headache, localized edema, peripheral edema, involuntary muscle contractions, somnolence, and dysuria. For those receiving monotherapy, events included nasopharyngitis, headache, pyrexia, nausea, facial edema, peripheral swelling, and cough.
In conclusion, a fixed-dose combination of low-dose, prolonged release pregabalin with etoricoxib was found to improve pain and functional status more significantly than monotherapy with etoricoxib among patients with chronic low back pain reporting severe pain. The study authors comment, “The studied FDC could address both the neuropathic and nociceptive components of CLBP. Thus, considering the observed efficacy and safety profile of the pregabalin prolonged release 75 mg and etoricoxib 60 mg, it can be considered as a useful and viable therapeutic option for treating CLBP with neuropathic component.”
Disclosure: This study was funded by Sun Pharma Laboratories Limited. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Yeole AB, Lakshmi SR, 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. Published online October 12, 2022. doi:10.1007/s40122-022-00437-2