Peripheral diabetic neuropathy affects between 20% and 45% of patients with diabetes.
To ascertain the effect of lacosamide on pain associated with peripheral diabetic neuropathy.
One hundred nineteen patients with a 1 to 5-year history of pain attributed to diabetic neuropathy and a score of ≥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.
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 ≥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.
Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues.
*The Center for Clinical Research, Winston-Salem, NC
†Nerve and Muscle Center of Texas, Houston, TX
‡Clinical Trials, Inc, Little Rock, AR
§Therapeutic Area Neurology, Schwarz Biosciences, Inc, RTP, NC
∥Clinical Operations, Schwarz Biosciences, Inc, Monheim, Germany
Financial Support: Schwarz Pharma AG, Monheim, Germany, provided the trial supplies and Schwarz BioSciences, Inc, Research Triangle Park, NC sponsored and funded the trial.
Reprints: Richard L. Rauck, MD, 145 Kimel Park Drive, Suite 330, Winston-Salem, NC 27103 (e-mail: firstname.lastname@example.org).
Received for publication October 4, 2005; accepted September 18, 2006