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Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN).

Abstract

OBJECTIVE

To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg).

METHODS

This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation.

RESULTS

Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (-2.1 vs. -1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported "much" or "very much" improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (-2.3 vs. -1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%).

CONCLUSION

Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Translational Pain Research, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. csang@partners.org

    , ,

    Source

    The Clinical journal of pain 29:4 2013 Apr pg 281-8

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Amines
    Analgesics
    Cyclohexanecarboxylic Acids
    Delayed-Action Preparations
    Double-Blind Method
    Drug Administration Schedule
    Female
    Gabapentin
    Humans
    Male
    Middle Aged
    Neuralgia, Postherpetic
    Pain Measurement
    Severity of Illness Index
    Treatment Outcome
    gamma-Aminobutyric Acid

    Pub Type(s)

    Clinical Trial, Phase III
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22801243

    Citation

    Sang, Christine N., et al. "Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN)." The Clinical Journal of Pain, vol. 29, no. 4, 2013, pp. 281-8.
    Sang CN, Sathyanarayana R, Sweeney M, et al. Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). Clin J Pain. 2013;29(4):281-8.
    Sang, C. N., Sathyanarayana, R., & Sweeney, M. (2013). Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). The Clinical Journal of Pain, 29(4), pp. 281-8. doi:10.1097/AJP.0b013e318258993e.
    Sang CN, et al. Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN). Clin J Pain. 2013;29(4):281-8. PubMed PMID: 22801243.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). AU - Sang,Christine N, AU - Sathyanarayana,Rekha, AU - Sweeney,Michael, AU - ,, PY - 2012/7/18/entrez PY - 2012/7/18/pubmed PY - 2013/8/27/medline SP - 281 EP - 8 JF - The Clinical journal of pain JO - Clin J Pain VL - 29 IS - 4 N2 - OBJECTIVE: To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg). METHODS: This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation. RESULTS: Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (-2.1 vs. -1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported "much" or "very much" improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (-2.3 vs. -1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%). CONCLUSION: Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/22801243/Gastroretentive_gabapentin__G_GR__formulation_reduces_intensity_of_pain_associated_with_postherpetic_neuralgia__PHN__ L2 - http://Insights.ovid.com/pubmed?pmid=22801243 DB - PRIME DP - Unbound Medicine ER -