Background & Aims
Diabetic polyneuropathic pain (DPN) and post-herpetic neuralgia (PHN) are chronic neuropathic pain conditions that impact across the domains of the quality of life. Gabapentinoids are considered first-line treatments for these painful conditions. Mirogabalin besylate (DS-5565) is a novel gabapentinoid that aims in translating long-lasting analgesic effects with a wider margin for side effects through the different actions on the ?2?-1 and ?2?-2 subunits. The objectives of this review are to determine the current literature available on the effectiveness in pain reduction of mirogabalin compared to placebo or pregabalin and identify the treatment emergent adverse reactions.
Methods
This study followed the guidelines included in the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) Consensus Statements. Relevant studies from 2019 to 2023 on the use of mirogabalin in the reduction of pain among patients with diabetic polyneuropathic pain or post-herpetic neuralgia were searched in computerized bibliographic databases, which included PubMed/MEDLINE, PubMed Central, The Cochrane Library, ClinicalTrials.Org, Google Scholar, LILACS and HERDIN Database of the Philippines. Randomized controlled trials that assessed the effectiveness using outcome measures such as ADPS, VAS in SF-MPQ and mBPI were considered. Assessment of risk of bias for randomized controlled trials was performed using the Risk of Bias 2.0 (RoB 2.0) tool.
Results
Four (4) RCTs matched the inclusion trial for DPN, while 1 RCT matched with PHN. The quality of the RCTs were assessed as high quality using the RoB 2.0 tool. Significant reductions on pain assessment outcome measures were demonstrated with mirogabalin at 30mg per day compared with placebo and pregabalin 300mg per day for both DPN and PHN. The most common treatment emergent adverse reactions (TEAEs) were mild to moderate in nature specifically somnolence and dizziness.
Conclusions
Our systematic review demonstrated that patients with DPNP, mirogabalin treatment was more effective compared to either placebo or pregabalin 300mg per day. Mirogabalin 15-30mg per day also showed superiority over placebo in patients with PHN. The safety and incidence of TEAEs were mild to moderate and could be managed conservatively. Larger phase III clinical trials are needed to consolidate more data for further analysis.
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Presenting Author
Justine Cervin Andrei Zamora
Poster Authors
Topics
- Specific Pain Conditions/Pain in Specific Populations: Neuropathic Pain - Peripheral