An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy.
OBJECTIVE
Painful idiopathic distal sensory polyneuropathy is common, but has been largely ignored as a model for the evaluation of neuropathic pain therapies. We have therefore conducted a safety, tolerability, and effectiveness study of the lidocaine patch 5% in painful idiopathic distal sensory polyneuropathy.


METHODS
A prospective open-label, flexible dosing, 3-week study period with a 5-week extension.


METHODS
Peripheral Neuropathy clinics and Anesthesiology Clinical Research Center at a tertiary care facility.


METHODS
Twenty subjects with a diagnosis of idiopathic distal sensory polyneuropathy (with or without associated impaired glucose tolerance), with a baseline mean pain daily rating of > or =4 on a visual analog scale. Intervention. Lidocaine patch 5%, maximum of four patches daily for 18 hours.


METHODS
Change from baseline week to week 3 mean daily diary pain ratings. Secondary endpoints included assessments of safety and tolerability as well as quality of life measures.


RESULTS
Subjects with idiopathic distal sensory polyneuropathy, both with and without impaired glucose tolerance, showed significant improvements in pain and quality of life outcome measures over a 3-week treatment period. These improvements were maintained in a subgroup of patients treated for an additional 5 weeks and permitted a taper of concomitant analgesics in 25% of subjects. The lidocaine patch 5% was well tolerated.


CONCLUSIONS
The lidocaine patch 5% appeared well tolerated and potentially effective in the management of painful idiopathic distal sensory polyneuropathy. Idiopathic distal sensory polyneuropathy is an appropriate patient population for the conduct of clinical trials of neuropathic pain therapies.
Herrmann
David N
DN
Department of Neurology, University of Rochester, Rochester, New York 14642, USA. David_Herrmann@urmc.rochester.edu
Barbano
Richard L
RL
Hart-Gouleau
Stephanie
S
Pennella-Vaughan
Janet
J
Dworkin
Robert H
RH
D000287:Administration, Topical; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D009437:Neuralgia / Q000188:drug therapy*; D009475:Neurons, Afferent; D011115:Polyneuropathies / Q000188:drug therapy*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
D000779:Anesthetics, Local; D008012:Lidocaine