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Randomized Controlled Trial
. 2008 Sep 16:8:33.
doi: 10.1186/1471-2377-8-33.

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

Joseph C Arezzo  1 , Julio Rosenstock, Linda Lamoreaux, Lynne Pauer
Affiliations
Randomized Controlled Trial

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

Joseph C Arezzo et al. BMC Neurol. .

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 >or=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 approximately 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.

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Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Weekly least-squares mean pain scores.
Figure 3
Figure 3
CGIC (A) and PGIC (B) scores.
Figure 4
Figure 4
Mean nerve amplitude (A) and nerve conduction (B) in patients treated with 600 mg/d pregabalin or placebo.
Figure 5
Figure 5
Median differences in nerve conduction parameters between treatment groups: pregabalin 600 mg/d vs. placebo.
See this image and copyright information in PMC

References

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