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Abstract: Context: Treatment options for postherpetic neuralgia (PHN), a complication of herpes zoster, are commonly unsatisfactory and associated with adverse events. Objectives: To evaluate the efficacy, onset of pain relief, and safety of gastroretentive gabapentin (G-GR) in patients with PHN. Methods: In two placebo-controlled studies, 357 patients with PHN were randomized to 1800mg G-GR and 364 patients were randomized to placebo taken with the evening meal. Patients underwent a two week titration, eight weeks of stable dosing, and one week of tapering. Efficacy assessments included change in average daily pain (ADP) score from baseline to Week 10, time to onset of pain relief, the proportion of patients feeling improved using the Patient Global Impression of Change, and the proportion of responders (≥30% pain reduction). Results: At Week 10, patients randomized to G-GR reported greater reductions in ADP score compared with placebo (−37.0% vs. −29.1; P =0.0025). More G-GR patients felt improved compared with placebo (44% vs. 33%; P =0.003) and responded to treatment (54% vs. 41%; P =0.001). As early as Day 2, greater pain reductions were observed for the G-GR group compared with the placebo group (−6.6% vs. −1.6%; P =0.0017). The median time to a one point or greater reduction in ADP score was four days for G-GR and six days for placebo (P <0.0001). The most frequently reported adverse events were dizziness (G-GR, 11%; placebo, 2%) and somnolence (G-GR, 5%; placebo, 3%). Conclusion: PHN pain reduction after G-GR treatment can be observed as early as the second day of dosing and continues for at least 10 weeks. [Copyright &y& Elsevier]

Abstract: Safety and efficacy data from a study of slow intrathecal (IT) ziconotide titration for the management of severe chronic pain are presented. Patients randomized to ziconotide (n =112) or placebo (n =108) started IT infusion at 0.1μg/hour (2.4μg/day), increasing gradually (0.05–0.1μg/hour increments) over 3 weeks. The ziconotide mean dose at termination was 0.29μg/hour (6.96μg/day). Patients'' baseline Visual Analogue Scale of Pain Intensity (VASPI) score was 80.7 (SD 15). Statistical significance was noted for VASPI mean percentage improvement, baseline to Week 3 (ziconotide [14.7%] vs. placebo [7.2%; P =0.036]) and many of the secondary efficacy outcomes measures. Significant adverse events (AEs) reported in the ziconotide group were dizziness, confusion, ataxia, abnormal gait, and memory impairment. Discontinuation rates for AEs and serious AEs were comparable for both groups. Slow titration of ziconotide, a nonopioid analgesic, to a low maximum dose resulted in significant improvement in pain and was better tolerated than in two previous controlled trials that used a faster titration to a higher mean dose. [Copyright &y& Elsevier]

Intraspinal drug infusion using fully implantable pump and catheter systems is a safe and effective therapy for selected patients with chronic pain. The options for this approach are increasing, as drugs that are commercially available for systemic administration are adapted to this use and other drugs that are in development specifically for intraspinal administration become available. In 2000 a Polyanalgesic Consensus Conference was organized to evaluate the existing literature and develop guidelines for drug selection. The major outcome of this effort, an algorithm for drug selection, was based on the best available evidence at the time. Rapid changes have occurred in the science and practice of intraspinal infusion and a Polyanalgesic Consensus Conference 2003 was organized to pursue the following goals: 1) to review the literature on intraspinal drug infusion since 1999, 2) to revise the 2000 drug-selection algorithm, 3) to develop guidelines for optimizing drug dosage and concentration, 4) to create a process for documenting minimum evidence supporting the use of a drug for intraspinal infusion, and 5) to clarify issues pertaining to compounding of drugs. Based on the best available evidence and expert opinion, consensus recommendations were developed in all these areas. The panel''s conclusions may provide a foundation for clinical practice and a rational basis for new research. [Copyright &y& Elsevier]