Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study.

Abstract

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.

DISCUSSION:

Lacosamide seems to attenuate pain in diabetic neuropathy in doses up to 400 mg/d and improves quality of life issues.

• Authors: Richard L Rauck, Aziz Shaibani, Victor Biton, Jeff Simpson, Brigitte Koch
• Journal: The Clinical journal of pain (Clin J Pain) Vol. 23 Issue 2 Pg. 150-8 (Feb 2007) ISSN: 0749-8047 [Print] United States
• PMID: 17237664 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Acetamides
• Analgesics
• Lacosamide

Topics

• Acetamides (adverse effects, therapeutic use)
• Aged
• Analgesics (adverse effects, therapeutic use)
• Diabetic Neuropathies (drug therapy, physiopathology)
• Double-Blind Method
• Drug Eruptions (etiology)
• Electrocardiography
• Female
• Gastrointestinal Diseases (chemically induced)
• Headache (chemically induced)
• Heart (drug effects, physiopathology)
• Humans
• Lacosamide
• Male
• Middle Aged
• Pain Measurement
• Quality of Life
• Treatment Outcome