Prediction of pregabalin-mediated pain response by severity of sleep disturbance in patients with painful diabetic neuropathy and post-herpetic neuralgia

Pain Med. 2014 Apr;15(4):661-70. doi: 10.1111/pme.12310. Epub 2013 Dec 11.


Objective: 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).

Design: A post-hoc analysis of data pooled from 16 placebo-controlled trials of pregabalin in patients with DPN or PHN.

Methods: 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.

Results: 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 P < 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.

Conclusion: 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.

Keywords: Diabetic Peripheral Neuropathy; Pain Response; Post-Herpetic Neuralgia; Predict; Pregabalin; Sleep Disturbance.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Analgesics / therapeutic use*
  • Diabetic Neuropathies / complications
  • Diabetic Neuropathies / drug therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neuralgia, Postherpetic / complications
  • Neuralgia, Postherpetic / drug therapy*
  • Pregabalin
  • Severity of Illness Index
  • Sleep Wake Disorders / etiology
  • Sleep Wake Disorders / physiopathology*
  • Treatment Outcome
  • Young Adult
  • gamma-Aminobutyric Acid / analogs & derivatives*
  • gamma-Aminobutyric Acid / therapeutic use


  • Analgesics
  • Pregabalin
  • gamma-Aminobutyric Acid