A placebo-controlled trial of lamotrigine for painful HIV-associated neuropathy

Simpson, David M.; Olney, Richard K.; McArthur, Justin C.; Khan, Amjad; Godbold, James; Ebel-Frommer, K.

doi:10.1212/wnl.54.11.2115

Cited by 222 publications

(106 citation statements)

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“…13 Subsequent studies have used a slightly higher dose (400 mg daily) as possibly being more efficacious. However, a subsequent randomized controlled trial that tested this higher dose in HIV neuropathy patients was negative.…”

Section: Discussionmentioning

confidence: 99%

“…[7][8][9][33][34][35][36][37] In addition, there are some clinical data (mostly from small uncontrolled clinical trials) suggesting a benefit to using lamotrigine for treating pain in normal volunteers or in patients with a variety of neuropathic syndromes. 10,[12][13][14][38][39][40][41][42][43][44][45][46] Conversely, several other studies have noted either a lack of benefit or an inconsistent benefit [47][48][49] when lamotrigine was tested for its benefit in neuropathy, a meta-analysis of all the placebo-controlled studies published concluding that there were no data to support the utility of lamotrigine as a therapy for pain syndromes. 50 This current trial adds to this literature, with evidence supporting the lack of efficacy of lamotrigine when used to treat CIPN-related symptoms.…”

Section: Discussionmentioning

confidence: 99%

“…Eligible patients were randomly treated with lamotrigine (target dose of 300 mg, based on published data suggesting that this was an effective dose 13 ) versus an identical-appearing placebo. Patients were started on a placebo or lamotrigine at a dose of 25 mg at bedtime for 2 weeks, then 25 mg twice daily for 2 weeks, then 50 mg twice daily for 2 weeks, then 100 mg twice daily for 2 weeks, and then the dose was escalated to 150 mg twice daily, at which time therapy continued for 2 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…In normal volunteers lamotrigine has been demonstrated to raise the threshold to cold-induced pain compared with placebo. 10 At the time this study was designed, data were available to suggest a role for lamotrigine in the therapy of pain from a variety of etiologies, including painful diabetic neuropathy, 11 central poststroke pain, 12 human immunodeficiency virus (HIV)-associated neuropathy, 13 and trigeminal neuralgia. 14 In addition to these data, local anecdotal experience of using lamotrigine to treat patients with CIPN suggested that some patients appeared to benefit with such therapy, with a reduction in pain and other symptoms (such as numbness and tingling).…”

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confidence: 99%

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Efficacy of lamotrigine in the management of chemotherapy‐induced peripheral neuropathy

Rao

Flynn

Sloan

et al. 2008

Cancer

169

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BACKGROUND.Lamotrigine, an antiepileptic agent, has been reported as being effective in reducing symptoms of neuropathy associated with various etiologies. Based on such data, a multicenter double‐blind, placebo‐controlled, randomized trial was conducted to evaluate the effect of lamotrigine on pain and other neuropathic symptoms due to chemotherapy‐induced peripheral neuropathy (CIPN).METHODS.Patients with symptomatic CIPN with symptom scores of either 1) >3 on a 0‐10 Numerical Rating Scale (NRS) or 2) >1 on the 0‐3 the Eastern Cooperative Oncology Group (ECOG) neuropathy scale (ENS) were eligible (higher numbers corresponding to greater severity of symptoms in both scales). Patients were randomly assigned to receive lamotrigine (target dose of 300 mg/day) or placebo for 10 weeks. Endpoints were measured biweekly.RESULTS.In all, 131 patients were enrolled. Both groups were well matched at baseline. Over the 10‐week period of the trial, the average pain scores (NRS) for the lamotrigine and placebo arms declined in both arms, with no statistically significant difference noted between the changes in the 2 groups (0.3 and 0.5 unit reduction from baseline, respectively; P = .56). Similarly, decreases in the ENS with therapy were not statistically different (0.4 and 0.3, respectively; P = .3). Changes in other subjective symptom scales were also not found to be statistically different between the 2 groups. Toxicities were mild and similar in each group.CONCLUSIONS.The results suggest that lamotrigine is not effective for relieving neuropathic symptoms in patients because of CIPN. Cancer 2008. © 2008 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Efficacy of lamotrigine in the management of chemotherapy‐induced peripheral neuropathy

Rao

Flynn

Sloan

et al. 2008

Cancer

169

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“…51 Lamotrigine is a third-line anticonvulsant which has shown modest efficacy for HIV-associated sensory neuropathy. 64 Selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and citalopram are not as effective as SSNRIs and TCAs. They have a NNT of 6.7 6 NMDA antagonists such as ketamine have thus far shown limited efficacy and often have intolerable side effects.…”

Section: Third-line Medicationsmentioning

confidence: 99%

Neuropathic pain—Current concepts

Meyer

2008

South African Family Practice

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Neuropathic pain (NP) represents a common and diverse group of disorders with peripheral and/or central nervous system damage or dysfunction. Many patients report intractable and severe pain that is resistant to simple analgesics. The diagnosis of NP is primarily based on clinical evaluation rather than diagnostic tests. Distinct pain qualities in the patient's history and findings on clinical examination, such as hyperalgesia and other sensory findings in an area correlating with the patient's pain pattern are important in diagnosis. Various screening tools may assist in the diagnosis of NP.A number of pathophysiological mechanisms have been identified in NP, including sodium-and calcium-channel upregulation and spinal cord hyperexcitability (central sensitisation).Appropriate management includes evaluation of the functional impact of NP, patient education and reassurance. A multi-model biopsychosocial approach that includes various nonpharmacological modalities is recommended. Appropriate pharmacological management is based on evidence-based recommendations that provide guidance for selecting first-, second-and third-line medications, alone or in combination. It is hoped that future treatment advances will improve the care of patients who live with NP.

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Advances in Neuropathic Pain

Dworkin¹,

Bačkonja²,

Rowbotham³

et al. 2003

Arch Neurol

1,082

190

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Chronic neuropathic pain, caused by lesions in the peripheral or central nervous system, comes in many forms. We describe current approaches to the diagnosis and assessment of neuropathic pain and discuss the results of recent research on its pathophysiologic mechanisms. Randomized controlled clinical trials of gabapentin, the 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and tricyclic antidepressants provide an evidence-based approach to the treatment of neuropathic pain, and specific recommendations are presented for use of these medications. Continued progress in basic and clinical research on the pathophysiologic mechanisms of neuropathic pain may make it possible to predict effective treatments for individual patients by application of a pain mechanism-based approach.

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A placebo-controlled trial of lamotrigine for painful HIV-associated neuropathy

Abstract: In this small trial, lamotrigine showed promise in the treatment of pain associated with HIV-related DSP. The frequency of rash was greater than in lamotrigine studies in epilepsy. A larger controlled study of lamotrigine is warranted.

Cited by 222 publications

References 17 publications

Efficacy of lamotrigine in the management of chemotherapy‐induced peripheral neuropathy

Efficacy of lamotrigine in the management of chemotherapy‐induced peripheral neuropathy

Neuropathic pain—Current concepts

Advances in Neuropathic Pain

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