Topiramate and physiologic measures of nerve function in polyneuropathy.
OBJECTIVE
To evaluate topiramate treatment on nerve function using electrophysiologic methods and a non-inferiority clinical trial design.


METHODS
A double-blind, multicenter, placebo-controlled trial was conducted in patients with painful diabetic polyneuropathy (n = 67). Change in peroneal motor nerve conduction velocity (NCV) was the primary outcome. NCVs of sural sensory and ulnar nerves, and amplitude and latency changes were measured secondarily. Peripheral nerve function was also evaluated in a patient subgroup reporting treatment-emergent paresthesias.


RESULTS
Least squares mean decrease in NCV was greater for placebo (-0.2 m/s) than for topiramate treatment (-0.1 m/s) (95% CI: -1.30, 1.42). Secondary measures showed no decrease in nerve function for topiramate-treated patients. Neurophysiologic measures were similar in patients with and without paresthesias. The most common adverse events with topiramate were paresthesias, anorexia, weight decrease, and taste perversion.


CONCLUSIONS
This nerve conduction study found no evidence that topiramate is associated with deterioration of nerve function.
Freeman
R
R
Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA 02215, USA. rfreeman@bidmc.harvard.edu
McIntosh
K A
KA
Vijapurkar
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Thienel
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D000368:Aged; D000927:Anticonvulsants / Q000494:pharmacology*; D003929:Diabetic Neuropathies / Q000503:physiopathology*; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives* / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009431:Neural Conduction / Q000187:drug effects*; D010543:Peroneal Nerve / Q000187:drug effects* / Q000503:physiopathology*; D013497:Sural Nerve / Q000187:drug effects / Q000503:physiopathology; D000077236:Topiramate; D014459:Ulnar Nerve / Q000187:drug effects / Q000503:physiopathology
D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose