Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study.
BACKGROUND
Peripheral diabetic neuropathy affects between 20% and 45% of patients with diabetes.


OBJECTIVE
To ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy.


METHODS
One hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of > or =4 on the Likert pain scale entered the multicenter, randomized, double-blind, placebo-controlled trial. Lacosamide (N=60) titrated from 100 to 400 mg/d or maximum tolerated dose and placebo (N=59) were the trial interventions. Primary efficacy criterion was change in pain score on the 11-point Likert pain scale. Secondary assessments included Short-Form McGill Pain and Short-Form-36 Quality of Life Questionnaires, sleep/activity interference, pain intensity, Patient and Clinical Global Impression of Change, and Profile of Mood. Patients receiving at least 1 dose of medication underwent safety evaluation.


RESULTS
Ninety-four patients (lacosamide 46; placebo 48) completed the trial. Lacosamide had significantly (P=0.039) better pain relief versus placebo (primary outcome). Improvements were also seen in secondary outcome measures. Adverse events occurred in 52 lacosamide and 44 placebo patients. Common adverse events, occurring in > or =5% of patients, were headache (lacosamide 18%, placebo 22%), dizziness (lacosamide 15%, placebo 8%), and nausea (lacosamide 12%, placebo 7%). Five lacosamide and 3 placebo patients withdrew for adverse events.


CONCLUSIONS
Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues.
Rauck
Richard L
RL
The Center for Clinical Research, Winston-Salem, NC, USA. rrauck@ccrpain.com
Shaibani
Aziz
A
Biton
Victor
V
Simpson
Jeff
J
Koch
Brigitte
B
D000081:Acetamides / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D003875:Drug Eruptions / Q000209:etiology; D004562:Electrocardiography; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006321:Heart / Q000187:drug effects / Q000503:physiopathology; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D016896:Treatment Outcome
D000081:Acetamides; D000700:Analgesics; D000078334:Lacosamide