Pregabalin relieves symptoms of painful diabetic neuropathy

Lesser, Henry; Sharma, Umang; LaMoreaux, L.; Poole, RM

doi:10.1212/01.wnl.0000145767.36287.a1

Cited by 529 publications

(381 citation statements)

References 27 publications

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“…The improvement in pain relief and sleep began during the first week of use. These results were confirmed in a separate, similar study completed by Lesser et al 86 in patients with DPN. In this study, however, both a 300 mg and 600 mg daily dose were shown to be superior to placebo, although there was no significant difference between the 300 and 600 mg/day dose.…”

Section: Pregabalinsupporting

confidence: 70%

Use of Antiepileptic Drugs for Nonepileptic Conditions: Psychiatric Disorders and Chronic Pain

2007

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Summary: Antiepileptic drugs (AEDs) are commonly utilized for nonepileptic conditions, including various psychiatric disorders and pain syndromes. Evidence for their benefit in these nonepileptic conditions varies widely among different drugs, but there is, in general, a paucity of published multicenter randomized double-blind trials. Variable levels of evidence suggest that lamotrigine and the vagal nerve stimulator have antidepressant properties. Carbamazepine, valproate, lamotrigine, and oxcarbazepine appear to have mood stabilizing properties while gabapentin, pregabalin, and tiagabine have anxiolytic benefits. Barbiturates, topiramate, and possibly phenytoin may precipitate or exacerbate depression. Underlying depression and anxiety symptoms may be exacerbated by levetiracetam, while psychotic symptoms have rarely been reported with topiramate, levetiracetam, and zonisamide. Pregabalin, gabapentin, carbamazepine, and oxcarbazepine have been used to treat neuropathic pain such as postherpetic neuralgia, and diabetic polyneuropathy. Topiramate and divalproex sodium have utility in the prophylaxis or acute treatment of migraine. Further rigorous studies are needed to clarify the utility of AEDs in nonepileptic conditions.

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Section: Pregabalinsupporting

confidence: 70%

Use of Antiepileptic Drugs for Nonepileptic Conditions: Psychiatric Disorders and Chronic Pain

2007

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“…There are seven double-blind, randomized, placebo-controlled trials in painful DPN with pregabalin (6 -12), five of which are published in full (7)(8)(9)(10)(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).…”

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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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“…Two other large clinical trials reported similar side-effect profiles. 12,13 More recently, a randomized, double-blind, placebo controlled trial showed that pregabalin (600 mg/day) was well-tolerated, and the adverse events were higher in the pregabalin arm. The most common adverse events due to pregabalin were, peripheral edema, dizziness, weight gain and somnolence.…”

Section: Discussionmentioning

confidence: 99%

Rash associated with Pregabalin: A case report

Alkan²,

Göker³

et al. 2013

J Clin Exp Invest

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ÖZETKırksekiz yaşında ve 2 aydır nöropati tedavisi için 300 mg/gün oral yolla pregabalin kullanan erkek hasta, ekstremiteler ve lomber bölgesinde eritematöz, makülopapü-ler döküntü şikayeti ile başvurdu. Naranjo olasılık skalası döküntü ve pregabalin kullanımı arasında muhtemel bir ilişkiyi gösterdi. Pregabalin tedavisi kesilerek, antihistaminik tedavi, oral metilprednizolon ve topical steroidli krem başlandı. Tedavinin kesilmesinden 1 hafta sonra döküntü neredeyse tamamen düzeldi. Pregabalin ilişkili döküntü faz 3 klinik çalışmalarda nadiren rapor edilmiştir. Pregabalin kullanımına eşlik eden döküntü daha önce yalnızca bir vaka raporunda sunulmuştur. Pregabalin ilişkili dökün-tünün mekanizması tam olarak anlaşılamamıştır. Düşük dozlarda pregabalin tedavisine başlamak ve doz artımını yavaş yapmak yan etki insidansını azaltabilir. Anahtar kelimeler: pregabalin, döküntü, multipl myelom ABSTRACTA 48-year-old man with erythematous, maculopapular rash localized to his extremities and lumbar region that he had been receiving oral pregabalin 300 mg per day for 2 months to treat his neuropathy was applied. The Naranjo probability scale indicates a probable relationship between the development of rash and use of pregabalin by our patient. Pregabalin was discontinued and antihistaminic treatment, oral methyprednisolone and topical steroid cream were given to treat the rash. The rash almost completely resolved one week after pregabalin was discontinued. Pregabalin-induced rash was rarely reported in Phase 3 clinical trials, and there is currently only one available report on the development of a rash coinciding with the use of pregabalin. No clear mechanisms reported for rash associated with pregabalin. It is usually recommended to start pregabalin with low doses and slow increases might prevent the incidence of side effects. J Clin Exp Invest 2013; 4 (1): 107-109

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Pregabalin relieves symptoms of painful diabetic neuropathy

Abstract: In patients with diabetic peripheral neuropathy, pregabalin demonstrated early and sustained improvement in pain and a beneficial effect on sleep, which were confirmed by positive patient global impression. Pregabalin was well tolerated at all doses.

Cited by 529 publications

References 27 publications

Use of Antiepileptic Drugs for Nonepileptic Conditions: Psychiatric Disorders and Chronic Pain

Use of Antiepileptic Drugs for Nonepileptic Conditions: Psychiatric Disorders and Chronic Pain

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

Rash associated with Pregabalin: A case report

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