The effect of pregabalin on pain-related sleep interference in diabetic peripheral neuropathy or postherpetic neuralgia: a review of nine clinical trials

Abstract

Objective:

Postherpetic neuralgia and painful diabetic peripheral neuropathy are common chronic neuropathic pain conditions associated with sleep disturbances. Pregabalin is indicated in the treatment of neuropathic pain. The objective of this review is to summarize the efficacy and safety of pregabalin in painful diabetic peripheral neuropathy and postherpetic neuralgia and the effect of pregabalin on sleep interference in these patients.

Methods:

MEDLINE and ISI Web of Knowledge databases were searched for randomized double-blind, placebo-controlled clinical trials of pregabalin reporting sleep measures in addition to pain endpoints in patients with painful diabetic peripheral neuropathy and postherpetic neuralgia published from inception through March 2009.

Results:

Nine trials met the inclusion criteria, providing data for a total of 2399 patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated twice or three times per day with pregabalin (75–600 mg/day) or placebo on a fixed or flexible schedule. Interpretation of sleep outcomes in two studies may be limited by trial inclusion criteria which permitted benzodiazepines for sleep problems. Also, none of the studies reported objective sleep measures. Pregabalin was well tolerated. Pregabalin (150–600 mg/day) significantly reduced pain and improved pain-related sleep interference.

Conclusions:

In addition to an analgesic benefit, pregabalin may decrease pain-related sleep interference in patients with painful diabetic peripheral neuropathy and postherpetic neuralgia.

Key words::

• Diabetic peripheral neuropathy (DPN)
• Neuropathic pain
• Postherpetic neuralgia (PHN)
• Pregabalin
• Sleep interference

Transparency

Declaration of funding

The trials described in this paper were funded by Pfizer Inc.

Declaration of financial/other relationships

T.R. has disclosed that he has received grants from Aventis, Cephalon, GlaxoSmithKline, Neurocrine, Pfizer, Sanofi, ScheringPlough, Sepracor, Somaxon, Syrex, Takeda, TransOral, Wyeth, and Xenoport, and has participated in speakers bureaus for Cephalon, Sanofi, and Takeda; that he is or has been a consultant for Abbott, Acadia, Acoglix, Actelion, Alchemers, Alza, Ancil, Arena, AstraZeneca, Aventis, BMS, Cephalon, Cypress, Dove, Elan, Eli Lilly, Evotec, Forest, GlaxoSmithKline, Hypnion, Intra-Cellular, Jazz, Johnson & Johnson, King, Lundbeck, McNeil, MediciNova, Merck, Neurim, Neurocrine, Neurogen, Novartis, Orexo, Organon, Prestwick, Procter and Gamble, Pfizer, Purdue, Resteva, Roche, Sanofi, ScheringPlough, Sepracor, Servier, Shire, Somaxon, Syrex, Takeda, TransOral, Vanda, Vivometrics, Wyeth, Yamanuchi, and Xenoport. R.S. has disclosed that he has received an honorarium from Pfizer for speaking at an international scientific meeting. His institution has received remuneration to cover costs of patient visits and recruitment during some of these studies and from other conducted studies sponsored by CeNeS, Grünenthal, Jazz Pharmaceutical Company, Takeda, Sanofi-Pasteur, and MundiPharma. T.K.M. has disclosed that he is a current employee and stockowner of Pfizer Inc.

Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she is the recipient of research/grant funding from Alcon, Abbott, Ortho-McNeil Janssen, Novartis, Sanofi-Aventis, NPS Pharmaceuticals, Boehringer-Ingelheim and TAP Pharmaceuticals, and is a consultant/advisor to, and member of the speakers bureau of Sanofi-Aventis. Peer Reviewer 2 has disclosed that he has acted as an advisor, consultant and speaker for Pricara, King Pharmaceuticals, Eli Lilly, and Pfizer; advisor, speaker and received grant support from Forest; a speaker and received grant support from Endo; advisor and speaker for Xanodyne and advisor for Vertex.

Acknowledgments

Editorial support for this paper was originally provided by Gregory Bezkorovainy and Mary Carter, Adelphi Inc., and funded by Pfizer Inc. Monique Antoine, UBC Scientific Solutions, provided editorial and administrative support on the final draft of the paper and was funded by Pfizer Inc.