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New Lidocaine Patch Safe and Effective for Diabetic
Neuropathic Pain
posted 06/30/04
The 5% lidocaine patch significantly reduces pain, improves
quality of life (QOL), and may allow tapering of concomitant analgesic therapy
in patients with painful diabetic polyneuropathy (DPN).
The investigators enrolled 56 patients with a minimum three-month history of
painful DPN. Subgroups included patients with allodyna (DPNA, n = 19) and
without allodyna (DPNNA, n = 37). Patients were allowed to cover the area of
maximal pain with 5% lidocaine patches up to four times daily in an 18-hour span
(six hours off) for three weeks. Dose increases in prior stabilized analgesic
therapy and new analgesic therapy were not allowed. Patients at one of three
participating institutions were treated for an additional five weeks, during
which taper of concomitant analgesic therapy was allowed.
At week 3, 70% of patients showed a significant reduction of at least 30% in
weekly mean pain diary ratings. Results were similar among patients with and
without allodyna.
QOL likewise showed significant improvement as measured by Brief Pain Inventory
(BPI) and short-form McGill Pain Questionnaire (SF-MPQ) total and subcategory
scores, as well as the Beck Inventory Depression (BID) score and scores on
several categories in the Profile of Mood States (POMS). Results were similar
between DPNA and DPNNA patients.
Of 28 patients treated for eight weeks, seven underwent tapering of concomitant
analgesic therapy. Three patients discontinued the additional pain medication
while four maintained the therapy at reduced dosage. The beneficial responses
observed at week 3 were maintained at week 8 regardless of whether patients had
allodyna.
No serious adverse effects occurred during the trial. Mean plasma lidocaine
levels remained stable and well below levels associated with an anti-arrhythmic
effect or toxicity throughout the study, indicating that systemic accumulation
did not occur. "These results suggest that the generally excellent tolerability
of the 5% lidocaine patch might translate to improvements in QOL that may be
less likely to occur with more poorly tolerated treatments...and the beneficial
response suggests that it may be an effective treatment for the management of
painful DPN," the authors note, suggesting that a double-blind, randomized,
vehicle-controlled trial is needed to confirm their observations.
Source: Diabetes In Control.com: Arch Neurol. 2004;61:914-918.
June News Article Index
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