Double-Blind, Placebo-Controlled Trial of Lamotrigine in Combination with Other Medications for Neuropathic Pain

Abstract

This randomized, double-blind, placebo-controlled study was undertaken to evaluate the efficacy and tolerability of lamotrigine added to gabapentin, a tricyclic antidepressant, or a nonopioid analgesic in patients whose neuropathic pain was inadequately controlled with these medications. Patients with neuropathic pain from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, trigeminal neuralgia, multiple sclerosis, or HIV-associated peripheral neuropathy, who had a mean weekly pain score > or =4 on an 11-point numerical rating scale, were randomized to receive a flexible dose of lamotrigine 200, 300, or 400mg daily (n=111) or placebo (n=109) for up to 14 weeks (including eight weeks of dose escalation) in addition to their prestudy regimen of gabapentin, a tricyclic antidepressant, or a nonopioid analgesic. No statistically significant difference in the mean change in pain-intensity score from baseline to Week 14 (primary endpoint) was detected between lamotrigine and placebo (P=0.67). Differences between lamotrigine and placebo were not statistically significant for secondary efficacy assessments, including mean changes from baseline in the Short-Form McGill Pain Questionnaire, the Neuropathic Pain Scale, rescue medication use, and the percentages of patients rated as much improved or very much improved at the end of treatment on the Clinician Global Impression of Change scale and the Patient Global Impression of Change scale. Lamotrigine was generally well tolerated. Lamotrigine (up to 400 mg/day) added to gabapentin, a tricyclic antidepressant, or a nonopioid analgesic did not demonstrate efficacy as an adjunctive treatment of neuropathic pain but was generally safe and well tolerated.

Recommendations for the Pharmacological Management of Neuropathic Pain: An Overview and Literature Update

“…[71][72][73][74][75][76][77] It is unclear whether these results reflect a true lack of efficacy in the specific conditions studied or whether other factors have accounted for the lack of success in demonstrating efficacy (eg, inadequate power to detect modest treatment benefits, excessive response rates in placebo groups, other methodological features of the trials).…”

Lamotrigine Versus Pregabalin in the Management of Refractory Trigeminal Neuralgia: A Randomized Open Label Crossover Trial

“…PGB, on the other hand, had not yet been tested in refractory cases of TN, although a single series does mention about its role as an adjunct in non-refractory patients [27]. A maximum dose of 400 mg/day for LTG was used in most trials [8,9,26,28] while the dosing range of 150-300 mg/day for PGB was considered to be the most effective in other reports [11][12][13]27]. The management in case of acute toxicity revolves around supportive care [29].…”

Классическая Невралгия Тройничного Нерва

“…В мире проводятся масштабные исследования по эффектив-ности других противосудорожных препаратов: окскарбазепин, клоназепам, ламотриджин, вальпроаты, габапентин [197,255,295,304,344,379,384,421].…”