19 Harley St, London, W1G 9QJ, UK

Efficacy And Safety Of Add-On Mirogabalin To NSAIDs In Lumbar Spinal Stenosis With Peripheral Neuropathic Pain: A Randomized, Open-Label Study London Spine

The London Spine Unit : most specialised spinal centre on Harley Street UK


Published article

CONCLUSIONS: The addition of mirogabalin to NSAIDs improved VAS, EQ-5D-5L, and PGIC. The main TEAEs were somnolence and dizziness. The addition of mirogabalin to NSAIDs improved peripheral neuropathic pain associated with LSS and raised no new safety concerns.
Lumbar Disc Replacement Expert. Best Spinal Surgeon UK

Abstract

Introduction: In Japan, conservative therapy for patients with lumbar spinal stenosis (LSS) includes non-steroidal anti-inflammatory drugs (NSAIDs), prostaglandin E1, tramadol, physical/exercise therapy, and nerve blocks. Mirogabalin, a selective oral α2δ ligand, is approved for treating peripheral neuropathic pain, though data regarding visual analog scores (VAS) for pain in patients with LSS are limited. We investigated the efficacy and safety of mirogabalin as an add-on treatment in patients with LSS taking NSAIDs compared with patients taking NSAIDs only.

Methods: This multicenter, randomized, open-label study (MiroTAS) was conducted at 32 centers in Japan between June 2020 and October 2021. Patients were randomly assigned to mirogabalin and NSAIDs or NSAIDs alone in a 1:1 ratio. NSAIDs were administered according to their Japanese package inserts; mirogabalin was administered based on renal function [creatinine clearance (CrCL) ≥ 60 mL/min, 5 mg twice daily (BID) in Weeks 1-2, 10 mg BID in Weeks 3-4, and 15 or 10 mg BID after Week 5; CrCL 30 to < 60 mL/min, 2.5 mg BID Weeks 1-2, 5 mg BID Weeks 3-4, and 7.5 or 5 mg BID after Week 5]. The primary endpoint was the change in VAS score for leg pain from baseline to Week 12. Secondary endpoints were quality of life, evaluated using the EuroQol five-dimensional descriptive system (EQ-5D-5L) (at baseline and Week 12) and Patient Global Impression of Change (PGIC) (at Week 12), and safety. Change in VAS score at Week 12 was calculated using a linear mixed model for repeated measures. The safety endpoints were treatment-emergent adverse events (TEAEs) and adverse drug reactions.

Results: In total, 220 patients who met the eligibility criteria were enrolled. In the mirogabalin and NSAIDs and NSAIDs groups, mean ages (67.8 vs. 70.9 years), proportions of female patients (54.5% vs. 49.0%), mean body weights (63.9 vs. 62.0 kg), mean CrCL values (81.5 vs. 70.7 mL/min), proportions of patients with CrCL 30 to < 60 mL/min (27.3% vs. 33.7%), mean VAS scores (63.8 vs. 62.8 mm), and proportions of patients with VAS score ≥ 60 (53.6% vs. 52.9%) at enrollment were similar. The median durations of LSS were 9.0 and 11.0 months and the spine pain DETECT questionnaire (SPDQ) scores were 6.8 and 7.8, respectively. The least square (LS) mean change in VAS score from baseline to Week 12 was - 24.1 mm in the mirogabalin and NSAIDs group and - 14.2 mm in the NSAIDs group (both P < 0.0001 vs. baseline). The difference in LS mean was - 9.9 [95% confidence interval (CI), - 18.0, - 1.8] (P = 0.0174). The improvement in EQ-5D-5L score at Week 12 was significantly greater in the mirogabalin and NSAIDs group versus the NSAIDs group [mean difference, 0.0529 (95% CI, 0.0036, 0.1022), P = 0.0357]. At Week 12, the proportions of patients with PGIC scores ≤ 3 and ≤ 2 were higher in the mirogabalin and NSAIDs group vs. the NSAIDs group (76.2% vs. 50.0%, P = 0.0006, and 47.6% vs. 32.4%, P = 0.0523). In the mirogabalin and NSAIDs group, the incidences of TEAEs and adverse drug reactions were 60.9% and 57.3%, respectively, and the most common TEAEs were somnolence (30.0%) and dizziness (25.5%).

Conclusions: The addition of mirogabalin to NSAIDs improved VAS, EQ-5D-5L, and PGIC. The main TEAEs were somnolence and dizziness. The addition of mirogabalin to NSAIDs improved peripheral neuropathic pain associated with LSS and raised no new safety concerns.

Trial registration: Japan Registry of Clinical Trials (jRCTs021200007).

Keywords: Lumbar spinal stenosis; Mirogabalin; NSAIDs; Peripheral neuropathic pain; α2δ ligands.

The London Spine Unit : most specialised spinal centre on Harley Street UK
Read more here:
Efficacy and Safety of Add-on Mirogabalin to NSAIDs in Lumbar Spinal Stenosis with Peripheral Neuropathic Pain: A Randomized, Open-Label Study

Doctors Specialising in Dynamic Spine Stabilisation Surgery
Mr Mo Akmal MD
Mr Mo Akmal, MD, stands as a innovator in the ...

Related Posts

0/5 (0 Reviews)

Trusindex Reviews

London Spine Unit Harley Street Hospital

A Focus on High Quality Specialised Care

We are a specialist Private Hospital based on Harley Street, London UK The Harley Street Hospital, Day Surgery Hospital

We provide exclusive health services for individuals seeking Advanced medical, non-surgical or minimally invasive treatments. We are covered by All Insurance Companies apart from AXA PPP

Our Medical Director and Lead Spinal Surgeon Mr Mo Akmal MD is a world renowned Spine Specialist Consultant with over 20 years of experience. He and his team have developed revolutionary techniques to perform all types of Spinal Surgery as a Day Case procedure without traditional General Anaesthetic.

We are constantly improving our techniques for treatment and improving facilities for our patients.

Book your Appointment Now 
Check out our Reviews 
Check out our Patient Videos 
Check our Mr Akmal’s Profile

 

What our patients say ...

Abstract Introduction: In Japan, conservative therapy for patients with lumbar spinal stenosis (LSS) includes non-steroidal anti-inflammatory drugs (NSAIDs), prostaglandin E1, tramadol, physical/exercise therapy, and nerve blocks. Mirogabalin, a selective oral α2δ ligand, is approved for treating peripheral neuropathic pain, though data regarding visual analog scores (VAS) for pain in patients with LSS are limited. We…
Spinal Stenosis Symptoms

Revolutionary Keyhole surgical technique to vaporise bulging discs

Dr Mo Akmal Medical Director
Dr Mo Akmal MD - Lead Spinal Surgeon

Laser Disc Surgery can be performed under local anaesthetic at The Harley Street Hospital.

Initial Consultation

with Consultant Spine Surgeon
£ 250
  • No Waiting Times
  • Top NHS affiliated Consultant
  • Includes Clinical Review and Report
  • Multidisciplinary discussion
  • Review of Previous Scans and Reports

Follow up Consultation

any appointment after initial consultation
£ 180
  • Top NHS affiliated Consultant
  • Includes Clinical Review and Report
  • Multidisciplinary discussion

High Resolution MRI Scan

any Single Region (3.0 Tesla)
£ 600
  • No waiting times
  • Includes Full Radiologist Report
  • Open or Closed MRI scan types
  • Copy of Scan on CD

Website Offer

Pre-Booked Online
£1130
£ 800
  • Initial Consultation
  • MRI Scan (Single Region)
  • Follow Up consultation
  • Same Day One Stop Visit
  • Full Medical and MRI scan Report
  • Copy of scan on CD
Popular

If you have any emergency Doctor’s need, simply call our 24 hour emergency

Your personal case manager will ensure that you receive the best possible care.

Call Now 

+44 844 589 2020
+44 203 973 8810