• Mark P Jensen, Ping H Hsu, and Geertrui F Vanhove.
• Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA 98104, USA. mjensen@uw.edu
• Pain Med. 2012 Aug 1; 13 (8): 105910661059-66.

ObjectiveThe objectives of this study were to identify and determine the validity of early decision criteria following once-daily gastroretentive gabapentin (G-GR) treatment in patients with postherpetic neuralgia (PHN).DesignIn two placebo-controlled studies, 279 patients were randomized to 1,800 mg G-GR and 270 to placebo with the evening meal; patients underwent a 2-week dose titration, followed by 8 weeks of stable dosing, and 1 week of dose tapering. Patients.  Adults with PHN for ≥6 months and an average baseline Numerical Pain Rating Scale (NPRS) score of ≥4 were included in the study.Outcome MeasuresPercent change from baseline to week 10 in NPRS scores and the percentage of responders (defined as ≥30% reduction in NPRS scores from baseline to week 10) were determined.MethodsPatients randomized to G-GR were categorized at each week based on their percent pain reduction up to that week, and for each category, the percentage of week 10 responders was computed. For several early-improvement criteria, the percentage of week 10 responders, odds ratios for achieving week 10 treatment response, sensitivity, and specificity were calculated.ResultsThere was a significant positive association between early pain reduction and week 10 treatment response. Pain reduction of <10% at week 5 of G-GR treatment was the best early predictor of lack of endpoint response, with only 8% of these patients moving on to become week 10 treatment responders.ConclusionsEarly response was a reliable predictor of final response. This approach holds promise for aiding clinicians in decision making regarding the need for alternative or supplemental treatment during G-GR therapy for PHN.Wiley Periodicals, Inc.

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