Abstract | CONTEXT: 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.
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Authors | Richard L Rauck, Gordon A Irving, Mark S Wallace, Geertrui F Vanhove, Michael Sweeney |
Journal | Journal of pain and symptom management
(J Pain Symptom Manage)
Vol. 46
Issue 2
Pg. 219-28
(Aug 2013)
ISSN: 1873-6513 [Electronic] United States |
PMID | 23149085
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Amines
- Analgesics
- Cyclohexanecarboxylic Acids
- Dosage Forms
- gamma-Aminobutyric Acid
- Gabapentin
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Topics |
- Amines
(administration & dosage)
- Analgesics
(administration & dosage)
- Causality
- Comorbidity
- Cyclohexanecarboxylic Acids
(administration & dosage)
- Disorders of Excessive Somnolence
(epidemiology)
- Dizziness
(epidemiology)
- Dosage Forms
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Compounding
- Drug-Related Side Effects and Adverse Reactions
(epidemiology)
- Female
- Gabapentin
- Humans
- Male
- Neuralgia, Postherpetic
(drug therapy)
- Pain Measurement
(drug effects, statistics & numerical data)
- Placebo Effect
- Prevalence
- Risk Factors
- Treatment Outcome
- United States
(epidemiology)
- gamma-Aminobutyric Acid
(administration & dosage)
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