A randomized, placebo-controlled study of oxcarbazepine in painful diabetic neuropathy

Großkopf, Josef; Mazzola, Jennifer L.; Wan, Ying; Hopwood, Margaret B.

doi:10.1111/j.1600-0404.2005.00559.x

Cited by 92 publications

(39 citation statements)

References 7 publications

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“…18 -20 Two studies showed no benefit, 18,20 but a third showed a moderate benefit-17% more patients on oxcarbazepine had a Ͼ50% pain reduction compared to placebo, with an NNT of 6.023. 19 The study showing a positive response had a slightly higher completion rate (73% 19 compared to 67%).…”

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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“…These agents, which include topiramate (14 -16), lamotrigine (17), oxcarbazepine (18,19), and gabapentin (20 -22) have shown varying efficacy in clinical trials.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Efficacy, Safety, and Tolerability of Pregabalin Treatment for Painful Diabetic Peripheral Neuropathy

2008

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EDITH DURSO-DECRUZ, PHD 2 BIROL EMIR, PHD 2 OBJECTIVE -To evaluate the efficacy, safety, and tolerability of pregabalin across the effective dosing range, to determine differences in the efficacy of three times daily (TID) versus twice daily (BID) dosage schedules, and to use time-to-event analysis to determine the time to onset of a sustained therapeutic effect using data from seven trials of pregabalin in painful diabetic peripheral neuropathy (DPN).RESEARCH DESIGN AND METHODS -Data were pooled across seven doubleblind, randomized, placebo-controlled trials using pregabalin to treat painful DPN with dosages of 150, 300, and 600 mg/day administered TID or BID. Only one trial included all three of these dosages, and TID dosing was used in four. All studies shared fundamental selection criteria, and treatment durations ranged from 5 to 13 weeks.RESULTS -Pooled analysis showed that pregabalin significantly reduced pain and painrelated sleep interference associated with DPN (150, 300, and 600 mg/day administered TID vs. placebo, all P Յ 0.007). Only the 600 mg/day dosage showed efficacy when administered BID (P Յ 0.001). Pain and sleep interference reductions associated with pregabalin appear to be positively correlated with dosage; the greatest effect was observed in patients treated with 600 mg/day. Kaplan-Meier analysis revealed that the median time to onset of a sustained (Ն30% at end point) 1-point improvement was 4 days in patients treated with pregabalin at 600 mg/day, 5 days in patients treated with pregabalin at 300 mg/day, 13 days in patients treated with pregabalin at 150 mg/day, and 60 days in patients receiving placebo. The most common treatment-emergent adverse events were dizziness, somnolence, and peripheral edema.CONCLUSIONS -Treatment with pregabalin across its effective dosing range is associated with significant, dose-related improvement in pain in patients with DPN. Diabetes Care 31:1448-1454, 2008T he prevalence of diabetic neuropathy is as high as 50% in patients who have had diabetes for 25 years (1), and painful diabetic peripheral neuropathy (DPN) occurs in up to 26% of all people with diabetes (2). Symptoms range from mild dysesthesias to severe unremitting pain that can profoundly impact patients' lives (3,4).Medications of several different classes are used to treat painful DPN with varying degrees of efficacy, safety, and tolerability. The antiepileptic agents gabapentin and pregabalin have attained widespread use in the treatment of painful DPN. These agents bind to the auxiliary ␣2-␦ subunit of the voltage-sensitive calcium channel, thereby decreasing Ca 2ϩ influx at nerve terminals and modulating neurotransmitter release (5).There are seven double-blind, randomized, placebo-controlled trials in painful DPN with pregabalin (6 -12), five of which are published in full (7-11). The effective dosing range for treatment of neuropathic pain syndromes is 150 to 600 mg/day, administered either three times daily (TID) or twice daily (BID). Among the seven trials, dosages of 150, 300, and 600 ...

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“…[44] Okskarbazepin, sodyum kanal blokajı yaparak analjezik etki gösterir; trigeminal nevralji, diyabetik polinöro-pati, radikülopati ve postherpetik nevraljide etkin olduğunu gösteren çalışmalar mevcuttur. [45][46][47] Nöropatik ağrı tedavisinde, 150 mg/gün dozuyla başlanarak, üç gün aralarla 150 mg'lık doz artışları yapılarak, maksimum 1800 mg/gün dozuna kadar çıkılır. Okskarbazepin, karaciğerde metabolize olur; başlıca yan etkileri arasında, dizziness, bulantı, baş dönmesi, bulanık görme ve ataksi bulunur.…”

Section: Anti̇epi̇lepti̇klerunclassified