Pregabalin is a first-line treatment in all major international guidelines on the management of
painful diabetic neuropathy (pDPN). Treatment with
pregabalin leads to a clinically meaningful improvement in
pain scores, offers consistent relief of
pain and has an acceptable tolerance level. Despite its efficacy in relieving
neuropathic pain, more robust methods and comprehensive studies are required to evaluate its effects in relation to co-morbid anxiety and sleep interference in pDPN. The sustained benefits of modulating
pain have prompted further exploration of other potential target sites and the development of alternative
GABAergic agents such as
mirogabalin. This review evaluates the role of
pregabalin in the management of pDPN as well as its potential adverse effects, such as
somnolence and
dizziness, which can lead to withdrawal in ~ 30% of long-term use. Recent concern about misuse and an increase in deaths linked to its use has led to demands for reclassification of
pregabalin as a class C
controlled substance in the UK. We believe these demands need to be tempered in relation to the difficulties it would create for repeat prescriptions for the many millions of patients with pDPN for whom
pregabalin provides benefit.Plain Language Summary: Plain language summary available for this article.