Long‐term oral lacosamide in painful diabetic neuropathy: A two‐year open‐label extension trial

Shaibani, Aziz; Biton, Victor; Rauck, Richard; Koch, Brigitte; Simpson, Jeffrey N.

doi:10.1016/j.ejpain.2008.05.016

Cited by 38 publications

(18 citation statements)

References 23 publications

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“…[21][22][23] All the studies showed a small reduction in pain with 400 mg/day of lacosamide (3%, 6%, and 6% compared to placebo), but in 2 studies no significant differences compared to placebo were observed with 600 mg/day of lacosamide. 22,23 In one study, benefits on general activity and sleep interference QOL measures were observed. 21 Conclusions.…”

Section: Analysis Of Evidence In Patients With Pdnmentioning

confidence: 99%

Evidence-based guideline: Treatment of painful diabetic neuropathy [RETIRED]

et al. 2011

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Objective: To develop a scientifically sound and clinically relevant evidence-based guideline for the treatment of painful diabetic neuropathy (PDN). Methods:We performed a systematic review of the literature from 1960 to August 2008 and classified the studies according to the American Academy of Neurology classification of evidence scheme for a therapeutic article, and recommendations were linked to the strength of the evidence. The basic question asked was: "What is the efficacy of a given treatment (pharmacologic: anticonvulsants, antidepressants, opioids, others; and nonpharmacologic: electrical stimulation, magnetic field treatment, low-intensity laser treatment, Reiki massage, others) to reduce pain and improve physical function and quality of life (QOL) in patients with PDN?" Results and Recommendations:Pregabalin is established as effective and should be offered for relief of PDN (Level A). Venlafaxine, duloxetine, amitriptyline, gabapentin, valproate, opioids (morphine sulfate, tramadol, and oxycodone controlled-release), and capsaicin are probably effective and should be considered for treatment of PDN (Level B). Other treatments have less robust evidence or the evidence is negative. Effective treatments for PDN are available, but many have side effects that limit their usefulness, and few studies have sufficient information on treatment effects on function and QOL. Neurology Diabetic sensorimotor polyneuropathy represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective.1,2 Painful diabetic neuropathy (PDN) affects 16% of patients with diabetes, and it is frequently unreported (12.5%) and more frequently untreated (39%).3 PDN presents an ongoing management problem for patients, caregivers, and physicians. There are many treatment options available, and a rational approach to treating the patient with PDN requires an understanding of the evidence for each intervention.This guideline addresses the efficacy of pharmacologic and nonpharmacologic treatments to reduce pain and improve physical function and QOL in patients with PDN. The pharmacologic agents reviewed include anticonvulsants, antidepressants, opioids, anti-arrhythmics, cannabinoids, aldose reductase inhibitors, protein kinase

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Section: Analysis Of Evidence In Patients With Pdnmentioning

confidence: 99%

Evidence-based guideline: Treatment of painful diabetic neuropathy [RETIRED]

et al. 2011

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“…Three Class III studies evaluated the efficacy of lacosamide 21–23. All the studies showed a small reduction in pain with 400 mg/day lacosamide (3%, 6%, and 6% compared with placebo), but in two studies no significant differences compared with placebo were observed with 600 mg/day lacosamide 22, 23. In one study, benefits on general activity and sleep interference QOL measures were observed 21…”

Section: Analysis Of Evidencementioning

confidence: 99%

Evidence‐based guideline: Treatment of painful diabetic neuropathy—report of the american association of neuromuscular and electrodiagnostic medicine, the american academy of neurology, and the american academy of physical medicine & rehabilitation

et al. 2011

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The objective of this report was to develop a scientifically sound and clinically relevant evidence-based guideline for the treatment of painful diabetic neuropathy (PDN). The basic question that was asked was: "What is the efficacy of a given treatment (pharmacological: anticonvulsants, antidepressants, opioids, others; non-pharmacological: electrical stimulation, magnetic field treatment, low-intensity laser treatment, Reiki massage, others) to reduce pain and improve physical function and quality of life (QOL) in patients with PDN?" A systematic review of literature from 1960 to August 2008 was performed, and studies were classified according to the American Academy of Neurology classification of evidence scheme for a therapeutic article. Recommendations were linked to the strength of the evidence. The results indicate that pregabalin is established as effective and should be offered for relief of PDN (Level A). Venlafaxine, duloxetine, amitriptyline, gabapentin, valproate, opioids (morphine sulfate, tramadol, and oxycodone controlled-release), and capsaicin are probably effective and should be considered for treatment of PDN (Level B). Other treatments have less robust evidence, or the evidence is negative. Effective treatments for PDN are available, but many have side effects that limit their usefulness. Few studies have sufficient information on their effects on function and QOL.

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“…Several clinical trials have confirmed its analgesia effect for painful DPN treatment [52]. Furthermore, long-term safety profile and sustained efficacy of lacosamide have been demonstrated in an open-label follow-on trial followed the DPN patients application of lacosamide up to about 2.5 years [53]. …”

Section: Other Therapeutic Approaches and Novel Drug Targetsmentioning

confidence: 99%

Translational Investigation and Treatment of Neuropathic Pain

Descalzi

et al. 2012

Mol Pain

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Neuropathic pain develops from a lesion or disease affecting the somatosensory system. Translational investigations of neuropathic pain by using different animal models reveal that peripheral sensitization, spinal and cortical plasticity may play critical roles in neuropathic pain. Furthermore, descending facilitatory or excitatory modulation may also act to enhance chronic pain. Current clinical therapy for neuropathic pain includes the use of pharmacological and nonpharmacological (psychological, physical, and surgical treatment) methods. However, there is substantial need to better medicine for treating neuropathic pain. Future translational researchers and clinicians will greatly facilitate the development of novel drugs for treating chronic pain including neuropathic pain.

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Long‐term oral lacosamide in painful diabetic neuropathy: A two‐year open‐label extension trial

Abstract: The long-term safety profile and sustained efficacy of lacosamide observed in this trial support its continued development for treatment of painful diabetic neuropathy.

Cited by 38 publications

References 23 publications

Evidence-based guideline: Treatment of painful diabetic neuropathy [RETIRED]

Evidence-based guideline: Treatment of painful diabetic neuropathy [RETIRED]

Evidence‐based guideline: Treatment of painful diabetic neuropathy—report of the american association of neuromuscular and electrodiagnostic medicine, the american academy of neurology, and the american academy of physical medicine & rehabilitation

Translational Investigation and Treatment of Neuropathic Pain

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