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Lamotrigine for HIV-associated painful sensory neuropathies: A
placebo-controlled trial
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Neurology 2003 May 13;60(9):1508-14
Simpson DM, McArthur JC, Olney R, Clifford D, So Y, Ross D, Baird BJ, Barrett
P, Hammer AE.
Mount Sinai School of Medicine (Dr. Simpson), New York, NY.
The objective of this study was to evaluate the efficacy and tolerability of
lamotrigine (LTG) for the treatment of pain in HIV-associated sensory
neuropathies. In a randomized, double-blind study, patients with HIV-associated distal
sensory polyneuropathy (DSP) received LTG or placebo during a 7-week dose
escalation phase followed by a 4-week maintenance phase. Randomization was
stratified according to whether or not patients were currently using neurotoxic
antiretroviral therapy (ART).
The number of patients randomized was 92 (62 LTG, 30 placebo) in the stratum
receiving
neurotoxic ART and 135 (88 LTG, 47 placebo) in the stratum not receiving
neurotoxic ART. Mean change from baseline in Gracely Pain Scale score for average
pain was not different between LTG and placebo at the end of the maintenance
phase in either stratum, but the slope of the change in Gracely Pain Scale
score for average pain reflected greater improvement with
LTG than with placebo in the stratum receiving neurotoxic ART (p = 0.004), as
did the mean change from baseline scores on the Visual Analogue Scale for
Pain Intensity and the McGill Pain Assessment Scale and patient and clinician
ratings of global impression of change in pain (p < /= 0.02). The incidence of
adverse events, including rash, was similar between LTG andplacebo.
Simpson concluded that lamotrigine was well-tolerated and effective for
HIV-associated neuropathic pain in patients receiving neurotoxic antiretroviral
therapy. Additional research is warranted to understand the differing response
among patients receiving neurotoxic antiretroviral therapy compared with those
not receiving neurotoxic antiretroviral therapy.
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