Tolerability and safety of gastroretentive once-daily gabapentin tablets for the treatment of postherpetic neuralgia.

ABSTRACT:

Objective

An immediate-release formulation of gabapentin is approved for treatment of postherpetic neuralgia (PHN). This formulation, however, requires multiple daily dosing, usually three times per day, and is associated with a high incidence of somnolence and dizziness. We assessed the tolerability and safety of a once-daily gastroretentive formulation of gabapentin (G-GR) in phase 3 clinical trials in patients with PHN.

Research design and methods

Data were pooled from two placebo-controlled studies involving 723 patients (G-GR 1800 mg, n = 359; placebo, n = 364). Patients (43% male, mean age 66 years) with PHN pain >4 (0-10 scale) for ≥3 months were enrolled. Summary statistics for the incidence of treatment-emergent adverse events (AEs) were performed. Laboratory parame

SUBMITTER: Irving GA 

PROVIDER: S-EPMC3392710 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature