Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised,

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Pain. 2005 Jun;115(3):254-63.

Efficacy of pregabalin in neuropathic pain evaluated in a 12-week,

randomised, double-blind, multicentre, placebo-controlled trial of

flexible- and fixed-dose regimens.

Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M.

Klinik fur Anaesthesiologie, Universitatsklinikum Dusseldorf,

nstr. 5, 40225 Dusseldorf, Germany.

Pregabalin binds with high affinity to the alpha(2)-delta subunit

protein of voltage-gated calcium channels and, thereby, reduces

release of excitatory neurotransmitters. This 12-week randomised,

double-blind, multicentre, placebo-controlled, parallel-group study

evaluated the efficacy and safety of pregabalin in patients with

chronic postherpetic neuralgia (PHN) or painful diabetic peripheral

neuropathy (DPN). Patients were randomised to placebo (n=65) or to

one of two pregabalin regimens: a flexible schedule of 150, 300, 450,

and 600mg/day with weekly dose escalation based on patients'

individual responses and tolerability (n=141) or a fixed schedule of

300mg/day for 1 week followed by 600mg/day for 11 weeks (n=132). Both

flexible- and fixed-dose pregabalin significantly reduced endpoint

mean pain score (primary outcome) versus placebo (P=0.002, P<0.001)

and were significantly superior to placebo in improving pain-related

sleep interference (P<0.001).

The most common adverse events (AEs) for pregabalin-treated patients

were dizziness, peripheral oedema, weight gain (not affecting

diabetes control), and somnolence. These results are consistent with

previous studies' demonstrating pregabalin's efficacy, tolerability,

and safety for treatment of chronic neuropathic pain associated with

DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy

and tolerability provides significant pain relief and may reduce

risks for AEs and therapy discontinuation.