Once-Daily Gastroretentive Gabapentin for Postherpetic Neuralgia: Integrated Efficacy, Time to Onset of Pain Relief and Safety Analyses of Data From Two Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Richard L. Rauck, MD, Gordon A. Irving, MD, Mark S. Wallace, MD, Geertrui F. Vanhove, MD, PhD, Michael Sweeney, MD Journal of Pain and Symptom Management Volume 46, Issue 2, Pages 219-228 (August 2013) DOI: 10.1016/j.jpainsymman.2012.07.011 Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 1 a) Patients randomized and b) patients treated. ∗n=1 did not receive study drug; qd = once daily; bid = twice daily (600 mg AM, 1200 mg PM); ITT=intent-to-treat; G-GR=gastroretentive gabapentin. Journal of Pain and Symptom Management 2013 46, 219-228DOI: (10.1016/j.jpainsymman.2012.07.011) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 2 Absolute and percent change in ADP score from baseline to Week 10. ADP=average daily pain; G-GR=gastroretentive gabapentin. Journal of Pain and Symptom Management 2013 46, 219-228DOI: (10.1016/j.jpainsymman.2012.07.011) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 3 Mean percent change in ADP score by day. G-GR showed greater improvement in mean pain scores than placebo (P<0.05) for all days except Days 1 and 65. Values shown are LS mean (SEM), estimated from the analysis of covariance model that includes treatment and center factors and baseline as a covariate. LS=least square; ADP=average daily pain; G-GR=gastroretentive gabapentin. Journal of Pain and Symptom Management 2013 46, 219-228DOI: (10.1016/j.jpainsymman.2012.07.011) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 4 Time to onset of pain relief. G-GR=gastroretentive gabapentin. Journal of Pain and Symptom Management 2013 46, 219-228DOI: (10.1016/j.jpainsymman.2012.07.011) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 5 Percentage of patients responding with ≥30% and ≥50% reduction in last observation carried forward ADP score from baseline. The P-value is based on the z-test for the difference in proportions between two groups. ADP=average daily pain; G-GR=gastroretentive gabapentin. Journal of Pain and Symptom Management 2013 46, 219-228DOI: (10.1016/j.jpainsymman.2012.07.011) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 6 PGIC and CGIC. Percent of patients in “very much improved” and “much improved” categories are combined. The P-value is from Fisher's exact test. PGIC=Patient Global Impression of Change; CGIC=Clinical Global Impressions of Change; G-GR=gastroretentive gabapentin. Journal of Pain and Symptom Management 2013 46, 219-228DOI: (10.1016/j.jpainsymman.2012.07.011) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions