Email updates

Keep up to date with the latest news and content from BMC Neurology and BioMed Central.

Open Access Highly Accessed Research article

Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: A double-blind placebo-controlled trial

Joseph C Arezzo1*, Julio Rosenstock2, Linda LaMoreaux3 and Lynne Pauer3

Author Affiliations

1 Albert Einstein College of Medicine, New York, NY, USA

2 Dallas Diabetes and Endocrine Center, Dallas, TX, USA

3 Pfizer Global Research & Development, Ann Arbor, MI, USA

For all author emails, please log on.

BMC Neurology 2008, 8:33  doi:10.1186/1471-2377-8-33

Published: 16 September 2008

Abstract

Background

Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID) versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC).

Methods

In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS) from daily pain diaries (11-point scale). NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment). At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving ≥50% reduction in MPS from baseline to endpoint). After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks.

Results

Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and ~5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p <.001). For all four nerves, 95% CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 (ie, no significant difference vs. placebo). Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint. More pregabalin-treated patients (49%) than controls (23%) were responders (p <.001).

Conclusion

Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN.

Trial registration

ClinicalTrials.gov NCT00159679