Mirogabalin Plus NSAIDs Reduce Leg Pain, Improve QOL in Lumbar Spinal Stenosis

Treatment with mirogabalin plus nonsteroidal anti-inflammatory drugs (NSAIDs) was found to improve leg pain and quality-of-life outcomes among patients with lumbar spinal stenosis compared with treatment with NSAIDs alone, according to the results of a study published in Pain Theory.

Patients (N=220) with lumbar spinal stenosis were enrolled in the MiroTAS study, which was a multicenter, randomized, open-label trial conducted at 32 sites in Japan between 2020 and 2021. Randomization occurred in a 1:1 ratio after stratifying patients on the basis of their 100-mm-point visual analogue scale (VAS) score for leg pain. Patients received mirogabalin 5 mg twice daily for 2 weeks followed by mirogabalin 10 mg twice daily for 2 weeks, then mirogabalin 10 mg to 15 mg twice daily through day 85 plus NSAIDs (n=110) or NSAIDs alone (n=104), respectively. The primary endpoint was change in VAS score for leg pain at 12 weeks.

The mean age of participants in the mirogabalin-plus-NSAIDs dual therapy and NSAIDs-only monotherapy cohorts was 67.8±11.3 and 70.9±9.2 years, baseline VAS scores were 63.8±13.4 and 62.8±13.9 mm, and the duration of radicular leg pain was 23.1±30.8 and 27.1±38.9 months, respectively.

From baseline to week 12, the least squares mean change in VAS score was -24.1±2.8 mm among the mirogabalin-plus-NSAIDs recipients (P <.0001) and -14.2±3.0 mm for the NSAIDs-alone recipients (P <.0001). Compared between groups, the addition of mirogabalin to NSAIDs was associated with a 9.9-point greater decrease in VAS score from baseline (P =.0174).

In the mirogabalin-plus-NSAIDs cohort, EuroQol 5-dimensional descriptive system (EQ-5D-5L) scores increased from a mean of 0.6525±0.1555 points at baseline to 0.7312±0.1587 points at week 12. For the NSAIDs-only group, EQ-5D-5L scores were 0.7008±0.1534 points at baseline increasing to 0.7267±0.1660 points at week 12. These values indicated that the addition of mirogabalin to NSAIDs significantly increased quality of life compared with treatment with NSAIDs alone (P =.0357).

During the Patient Global Impression of Change evaluation conducted at week 12, more patients in the dual-therapy cohort reported their symptoms had very much improved (10.7% vs 5.4%), much improved (36.9% vs 27.0%), minimally improved (28.6% vs 17.6%), or were much worse (4.8% vs 2.7%), and fewer reported their symptoms had not changed (15.5% vs 36.5%) or were minimally worse (3.6% vs 10.8%) compared with patients receiving NSAIDs monotherapy, respectively.

More recipients of mirogabalin plus NSAIDs reported treatment-emergent adverse events (TEAEs; 60.9% vs 14.2%) and adverse drug reactions (57.3% vs 3.8%) than recipients of NSAIDs, respectively. The most common TEAEs and adverse drug reactions reported among the dual-therapy cohort were somnolence (30.0%) and dizziness (25.5%). Nine recipients of mirogabalin plus NSAIDs discontinued treatment due to TEAEs; no recipients of NSAIDs alone discontinued treatment.

Limitations of this study include its open-label design, and the target sample size was not met due to interruption of recruitment because of the COVID-19 pandemic.

These data indicate that the addition of mirogabalin to NSAIDs was more effective than NSAIDs alone at decreasing leg pain and improving quality of life among patients with lumbar spinal stenosis. The investigators conclude, “The results of this study suggest that mirogabalin may be a new treatment option for pain in patients with [lumbar spinal stenosis], potentially broadening treatment options and improving quality of life for patients with [lumbar spinal stenosis] who experience pain.”

Disclosure: This research was supported by Daiichi Sankyo, Co., Ltd. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies.  Please see the original reference for a full list of disclosures.