Abstract
BackgroundRecent 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).MethodsIn 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.ResultsEighty-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).ConclusionPregabalin 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 registrationClinicalTrials.gov NCT00159679
Highlights
Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN)
Pregabalin has consistently proved an effective treatment for DPN and postherpetic neuralgia (PHN) in its extensive clinical trial program [916]
It is among the agents recommended by the American Academy of Neurology as a Group 1 treatment for PHN [17], and as a first-line treatment for painful polyneuropathy by the European Federation of Neurological Societies [18]
Summary
Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). Pregabalin has consistently proved an effective treatment for DPN and postherpetic neuralgia (PHN) in its extensive clinical trial program [916]. It is among the agents recommended by the American Academy of Neurology as a Group 1 treatment for PHN [17], and as a first-line treatment for painful polyneuropathy by the European Federation of Neurological Societies [18]. Recent consensus guidelines have identified pregabalin as one of the first-tier treatments for painful DPN [19,20]
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