Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13‐week, randomized trial

Seventer, Robert van; Feister, Hilary A.; Young, James P.; Stoker, Malcolm; Versavel, Mark; Rigaudy, Laurence

doi:10.1185/030079906x80404

Cited by 239 publications

(130 citation statements)

References 21 publications

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“…This finding is in contrast to studies of postherpetic neuralgia in which BID efficacy was demonstrated across a range of doses from 150 to 600 mg/day (24). The basis for this difference in efficacy between disease states is not known, although it may be related, in part, to the permitted use of concomitant pain medication in all postherpetic neuralgia pregabalin clinical trials (24 -26).…”

Section: Safety and Tolerabilitycontrasting

confidence: 53%

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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Section: Safety and Tolerabilitycontrasting

confidence: 53%

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

2008

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“…The most common adverse experiences reported were generally of mild or moderate intensity and similar in frequency to those previously reported for pregabalin in studies that enrolled HIV-negative individuals. [13][14][15][16][17][18][19][20][21][22][23][24][25] Based on the primary efficacy measure, change from baseline in mean NPRS score, the current study revealed no significant difference between placebo and pregabalin treatment arms. Similarly, there were no significant differences in the secondary pain measures, including responder rates based on Ն30% and Ն50% reduction in mean weekly pain score, mBPIsf, NPSI, and GPS.…”

Section: Resultsmentioning

confidence: 99%

“…11 In one small placebo-controlled trial, gabapentin was effective in reducing pain related to HIV-DSP. 12 Pregabalin, which has an improved pharmacokinetic profile, has shown efficacy in relieving neuropathic pain associated with diabetic peripheral neuropathy, [13][14][15][16][17] postherpetic neuralgia, [18][19][20] and spinal cord injury, 21,22 and pain associated with fibromyalgia. [23][24][25] The current controlled study evaluates the efficacy and safety of pregabalin in painful HIV-DSP.…”

mentioning

confidence: 99%

Pregabalin for painful HIV neuropathy

Simpson

Schifitto²,

Clifford³

et al. 2010

Neurology

189

120

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Objective: Pregabalin is effective in several neuropathic pain syndromes. This trial evaluated its efficacy, safety, and tolerability for treatment of painful HIV-associated neuropathy.Methods: This randomized, double-blind, placebo-controlled, parallel-group trial included a 2-week double-blind dose-adjustment (150 -600 mg/day BID) phase, a 12-week double-blind maintenance phase, and an optional 3-month open label extension phase. The primary efficacy measure was the mean Numeric Pain Rating Scale (NPRS) score, an 11-point numeric rating scale. Secondary measures included Patient Global Impression of Change (PGIC) and sleep measurements.Results: Baseline mean NPRS score was 6.93 for patients randomized to pregabalin (n ϭ 151) and 6.72 for those to placebo (n ϭ 151). Pregabalin average daily dosage (SD) was 385.7 (160.3) mg/d. At endpoint, pregabalin and placebo showed substantial reductions in mean NPRS score from baseline: Ϫ2.88 vs Ϫ2.63, p ϭ 0.3941. Pregabalin had greater improvements in NPRS score relative to placebo at weeks 1 (Ϫ1.14 vs Ϫ0.69, p ϭ 0.0131) and 2 (Ϫ1.92 vs Ϫ1.43, p ϭ 0.0393), and at weeks 7 (Ϫ3.22 vs Ϫ2.53 p ϭ 0.0307) and 8 (Ϫ3.33 vs Ϫ2.53, p ϭ 0.0156). At all other time points, differences between groups were not significant. Sleep measurements and 7-item PGIC did not differ among treatment groups; however, collapsed PGIC scores showed 82.8% of pregabalin and 66.7% of placebo patients rated themselves in 1 of the 3 "improved" categories (p ϭ 0.0077). Somnolence and dizziness were the most common adverse events with pregabalin.

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“…Other published studies have confirmed these results for DPN and PHN. 87,88 In an eight-week multicenter randomized controlled study, pregabalin at 450 mg/day was found to reduce significantly the average severity of pain in patients with fibromyalgia. Other benefits included improvement in sleep quality and fatigue.…”

Section: Pregabalinmentioning

confidence: 99%

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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Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13‐week, randomized trial

Abstract: Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated. It also reduced the extent to which pain interfered with sleep. Pregabalin's effects were seen as early as week 1 and were sustained throughout the 13-week study.

Cited by 239 publications

References 21 publications

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

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

Pregabalin for painful HIV neuropathy

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

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