Prediction of Pregabalin‐Mediated Pain Response by Severity of Sleep Disturbance in Patients with Painful Diabetic Neuropathy and Post‐Herpetic Neuralgia. Issue 4 (11th December 2013)

• Record Type: Journal Article
• Authors: Vinik, Aaron; Emir, Birol; Parsons, Bruce; Cheung, Raymond
• Is Part Of: Pain medicine. Volume 15:Issue 4(2014)
• Page Start: 661
• Page End: 670
• Publication Date: 2013-12-11
• Subjects: Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesics -- Periodicals; Pain -- Periodicals; Pain Management -- Periodicals; Douleur -- Périodiques; Douleur -- Traitement -- Périodiques; Analgésiques -- Périodiques; Analgésique; Soulagement de la douleur; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.047205
• DOI: 10.1111/pme.12310
• Languages: English
• ISSNs: 1526-2375

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="pme12310-sec-0001" sec-type="section"> <title>Objective</title> <p>To evaluate the predictive value of disturbed sleep on the ability of pregabalin to reduce pain associated with diabetic peripheral neuropathy (DPN) and post‐herpetic neuralgia (PHN).</p> </sec> <sec id="pme12310-sec-0002" sec-type="section"> <title>Design</title> <p>A post‐hoc analysis of data pooled from 16 placebo‐controlled trials of pregabalin in patients with DPN or PHN.</p> </sec> <sec id="pme12310-sec-0003" sec-type="section"> <title>Methods</title> <p>Pain relief at endpoint was compared in patients with mild, moderate, or severe levels of baseline sleep disturbance. Sleep disturbance was based on a scale from 0–10 and scores <4, 4 to 7, and ≥7 were classified as mild, moderate, and severe, respectively.</p> </sec> <sec id="pme12310-sec-0004" sec-type="section"> <title>Results</title> <p>Pregabalin significantly reduced mean pain scores in the DPN (N = 3, 056) and PHN (N = 1, 471) cohorts (mean placebo‐adjusted reductions were −0.73 and −1.08 for patients with DPN/PHN, respectively; both <italic>P </italic><<italic> </italic>0.05). The greatest extent of pain relief occurred in patients with severe sleep interference scores at baseline. Data analyses using the pooled DPN/PHN population identified a subset of patients (N = 707) exhibiting marked levels of pain relief at endpoint (mean placebo‐adjusted reduction of −2.88), all of whom had severe sleep interference scores at baseline. Baseline sleep interference scores were a moderately good predictor of global patient improvement in response to pregabalin treatment in both patient cohorts. Finally, path analysis showed a high degree of association between improvements in sleep and pain relief in patients with DPN/PHN.</p> </sec> <sec id="pme12310-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Overall, these data suggest that the presence of comorbid sleep disturbance in patients with DPN/PHN might, in part, predict substantial pain relief in response to pregabalin treatment.</p> </sec> </abstract>