Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking

Huffman, Cynthia; Stacey, Brett R.; Tuchman, Michael; Burbridge, Claire; Li, Chunming; Parsons, Bruce; Pauer, L.; Scavone, Joseph M.; Behar, Regina; Yurkewicz, Lorraine

doi:10.1097/ajp.0000000000000198

Cited by 23 publications

(16 citation statements)

References 50 publications

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“…It is possible that the better quality of sleep accounts for the great PGIC improvement. Results are similar to those obtained in painful diabetic neuropathy [19][20]39 .…”

Section: Discussionsupporting

confidence: 89%

The Efficacy of Pregabalin in the Treatment of Prediabetic Neuropathic Pain

González‐Duarte

Lem

Díaz-Díaz

et al. 2016

The Clinical Journal of Pain

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“…It is possible that the better quality of sleep accounts for the great PGIC improvement. Results are similar to those obtained in painful diabetic neuropathy [19][20]39 .…”

Section: Discussionsupporting

confidence: 89%

The Efficacy of Pregabalin in the Treatment of Prediabetic Neuropathic Pain

González‐Duarte

Lem

Díaz-Díaz

et al. 2016

The Clinical Journal of Pain

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“…For example, the MD for mean NRS is -0.76 (-1.64, 0.61) for mixed followup versus -0.57 (-1.57, 1.06) for less than 12 weeks only. The finding that there is no clear difference also holds true in Baron 2009 17 Binder 2009 58 Bischoff 2013 48 Cheville 2009 49 Demant 2015 50 Dworkin 2003 28Eli Lilly 2010 18 Freynhagen 2005 37 Galer 1999 51 Galer 2002 29 Gilron 2011 21Grunenthal 2011 39 Guan 2011 46 Hewitt 2011 52 Huffman 2015 53 Jenkins 2012 54 Jiang 2011 19 Lesser 2004 20 Lin 2008 30 Liu 2017 31 Markman 2018 44 Meier 2003 55 Moon 2010 47 Mu 2018 21 Ogawa 2010 32 Palladini 2019 40 Penide 2012 41 Pickering 2017 42 Raskin 2014 56 Raskin 2016 57 Rauck 2013 22 Richter 2005 23 Rosenstock 2004 24 Rowbotham 1996 33 Sabatowski 2004 34 Sansone 2017 43 Satoh 2011 25 Stacey 2008 35 Tolle 2008…”

Section: Network Meta-analysis: Outputsmentioning

confidence: 94%

Systematic review and network meta-analysis of the efficacy and safety of lidocaine 700 mg medicated plaster vs. pregabalin

Buksnys

Armstrong

Sabatschus

et al. 2019

Current Medical Research and Opinion

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Objective: Neuropathic pain prevalence is estimated between 7% and 10% of the population. International guidelines recommend a variety of drugs at different therapy lines for pain relief. However, side effect profiles, for example, prompted the UK government recently to classify pregabalin and gabapentin as class C drugs. Lidocaine 700 mg medicated plaster (LMP) might be a safer alternative. A systematic review assessed how LMP and pregabalin compared in terms of efficacy and safety. The review focused on pain reduction, quality of life and adverse events in peripheral neuropathic pain (PNP) i.e. post-herpetic neuralgia, diabetic peripheral neuropathy, post-surgical/trauma, or other PNP conditions. Methods: Electronic databases were searched as well as a number of other sources up to November 2018. Sensitive strategies were used, with no restriction by language or publication status. Two independent reviewers screened records and extracted data with consensus determining final decisions. Risk of bias was assessed using the Cochrane Collaboration 2011 checklist for RCTs. Full network meta-analysis was conducted to compare LMP to pregabalin 300/600 mg in terms of pain reduction, quality of life, as well as serious adverse events and selected adverse events. Trials with enriched enrolment design were excluded. Results: Searches retrieved 7,104 records. In total 111 references pertaining to 43 RCTs were included for data extraction. Bayesian network meta-analysis of several pain outcomes showed no clear difference in efficacy between treatments However, LMP was clearly advantageous in terms of dizziness and any adverse event vs. pregabalin 600 mg/day and discontinuations vs. pregabalin 300 mg/day or 600 mg/day, as well as being associated with improved quality of life (albeit in this case based on weak evidence). Conclusions: LMP was found to be similar to pregabalin in reducing pain in all populations but had a better adverse events profile.

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“…This was a total of 27 trials: 1008–1014, 23 1008–1029, 24 1008–1030, 25 1008–1040, 25 1008–1045, 26 1008–1125, 27 1008–1127, 28 1008–1131, 29 1008–1149, 30 1008–1155, 19 1008–1196, 31 A0081004 (ClinicalTrials. gov: NCT00159666), 18 A0081030 (NCT00156078), 17 A0081037 (NCT00141219), 22 A0081060 (NCT00159679), 32 A0081064 (NCT00292188), 21 A0081066, 33 A0081071 (NCT00143156), 17 A0081081 (NCT00301223), 20 A0081107 (NCT00407745), 34 A0081120 (NCT00394901), 35 A0081163 (NCT00553475), 36 A0081244 (NCT01049217), 37 A0081265 (NCT01332149), A0081268 (NCT01455415), 38 A0081269 (NCT01474772), 39 and A0081276 (NCT01455428). 40 Some historical trials are not recorded at ClinicalTrials.gov .…”

Section: Methodsmentioning

confidence: 99%

Neuropathic pain responds better to increased doses of pregabalin: an in-depth analysis of flexible-dose clinical trials

Serpell

Latymer

Almas

et al. 2017

JPR

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BackgroundPregabalin is an effective treatment option for many patients with neuropathic pain. Higher doses of pregabalin have been shown to be more effective in improving pain outcomes but, in practice, failing to appropriately increase the dose can leave patients under-treated.MethodsThis was a pooled analysis of 6 flexible-dose clinical trials of pregabalin in patients with neuropathic pain (diabetic peripheral neuropathy, peripheral herpetic neuralgia, posttraumatic pain, or postsurgical pain). Patients were divided into “dose pathway” groups based on their weekly pregabalin dose from the start of their trial to the first week of their maintenance phase. These were: 150 mg/day only; 150 to 300 mg/day; 150 to 300 to 450 mg/day; 150 to 300 to 450 to 600 mg/day; 150 to 300 to 600 mg/day; 300 to 600 mg/day. Pain outcomes assessed for each group at each new dose were proportion of 30% and 50% responders (≥30% or ≥50% reduction in mean pain score from baseline) and mean change in pain score. Percent change in mean pain score from baseline was assessed using a marginal structural model.ResultsSeven hundred and sixty-one patients treated with flexible-dose pregabalin were included in the analysis. For each dose pathway group, there was a notably greater proportion of 30% and 50% responders and change in pain score, at each escalating dose. As assessed by the marginal structural model, higher doses of pregabalin were estimated to result in a significantly greater change in mean pain score at each week. This dose response with flexible-dose pregabalin was consistent with that previously observed with fixed-dose pregabalin.ConclusionMany patients who do not respond to lower doses of pregabalin will respond with notable improvements in pain outcomes when the dose is escalated. These data should encourage physicians treating patients with neuropathic pain to escalate pregabalin to the dose that delivers optimal analgesia and tolerable side effects.

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Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking

Abstract: Failure to meet the co-primary objectives may be related to carryover effect from period 1 to period 2, lower pregabalin dose (150 to 300 mg/d), and/or placebo response in painful DPN.

Cited by 23 publications

References 50 publications

The Efficacy of Pregabalin in the Treatment of Prediabetic Neuropathic Pain

The Efficacy of Pregabalin in the Treatment of Prediabetic Neuropathic Pain

Systematic review and network meta-analysis of the efficacy and safety of lidocaine 700 mg medicated plaster vs. pregabalin

Neuropathic pain responds better to increased doses of pregabalin: an in-depth analysis of flexible-dose clinical trials

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