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Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study.
Clin J Pain. 2007 Feb; 23(2):150-8.CJ

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+Show Affiliations

The Center for Clinical Research, Winston-Salem, NC, USA. rrauck@ccrpain.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17237664

Citation

Rauck, Richard L., et al. "Lacosamide in Painful Diabetic Peripheral Neuropathy: a Phase 2 Double-blind Placebo-controlled Study." The Clinical Journal of Pain, vol. 23, no. 2, 2007, pp. 150-8.
Rauck RL, Shaibani A, Biton V, et al. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007;23(2):150-8.
Rauck, R. L., Shaibani, A., Biton, V., Simpson, J., & Koch, B. (2007). Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. The Clinical Journal of Pain, 23(2), 150-8.
Rauck RL, et al. Lacosamide in Painful Diabetic Peripheral Neuropathy: a Phase 2 Double-blind Placebo-controlled Study. Clin J Pain. 2007;23(2):150-8. PubMed PMID: 17237664.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. AU - Rauck,Richard L, AU - Shaibani,Aziz, AU - Biton,Victor, AU - Simpson,Jeff, AU - Koch,Brigitte, PY - 2007/1/24/pubmed PY - 2007/2/28/medline PY - 2007/1/24/entrez SP - 150 EP - 8 JF - The Clinical journal of pain JO - Clin J Pain VL - 23 IS - 2 N2 - 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. SN - 0749-8047 UR - https://www.unboundmedicine.com/medline/citation/17237664/Lacosamide_in_painful_diabetic_peripheral_neuropathy:_a_phase_2_double_blind_placebo_controlled_study_ L2 - http://dx.doi.org/10.1097/01.ajp.0000210957.39621.b2 DB - PRIME DP - Unbound Medicine ER -