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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.
J Pain Symptom Manage. 2013 Aug; 46(2):219-28.JP

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.

Authors+Show Affiliations

Center for Clinical Research, Winston-Salem, North Carolina, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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

23149085

Citation

Rauck, Richard L., et al. "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." Journal of Pain and Symptom Management, vol. 46, no. 2, 2013, pp. 219-28.
Rauck RL, Irving GA, Wallace MS, et al. 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. J Pain Symptom Manage. 2013;46(2):219-28.
Rauck, R. L., Irving, G. A., Wallace, M. S., Vanhove, G. F., & Sweeney, M. (2013). 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. Journal of Pain and Symptom Management, 46(2), 219-28. https://doi.org/10.1016/j.jpainsymman.2012.07.011
Rauck RL, et al. 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. J Pain Symptom Manage. 2013;46(2):219-28. PubMed PMID: 23149085.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Rauck,Richard L, AU - Irving,Gordon A, AU - Wallace,Mark S, AU - Vanhove,Geertrui F, AU - Sweeney,Michael, Y1 - 2012/11/11/ PY - 2012/05/03/received PY - 2012/07/24/revised PY - 2012/07/28/accepted PY - 2012/11/15/entrez PY - 2012/11/15/pubmed PY - 2014/2/25/medline KW - Postherpetic neuralgia KW - gastroretentive gabapentin KW - onset of pain relief SP - 219 EP - 28 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 46 IS - 2 N2 - 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. SN - 1873-6513 UR - https://www.unboundmedicine.com/medline/citation/23149085/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(12)00397-1 DB - PRIME DP - Unbound Medicine ER -