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Safety and efficacy of once-daily gastroretentive gabapentin in patients with postherpetic neuralgia aged 75 years and over.
Drugs Aging. 2013 Dec; 30(12):999-1008.DA

Abstract

BACKGROUND

Treatment of postherpetic neuralgia (PHN) is more complicated in elderly patients, and multiple daily dosing, complex titration, and high incidences of adverse events can be limiting for many pharmacological treatment options.

OBJECTIVE

The aim of this study was to determine whether the efficacy and tolerability of once-daily gastroretentive gabapentin (G-GR) is similar between elderly patients (≥75 years) and younger patients (<75 years).

METHODS

Data from two phase III, placebo-controlled studies of 1,800 mg G-GR once daily with dinner in patients with PHN were integrated and analyzed by age subgroups (<75 years, n = 527; ≥75 years, n = 192). Efficacy assessments at endpoint (week 10) included baseline-adjusted change in average daily pain (ADP) and average daily sleep interference (SIS) scores, the proportion of responders (≥30 % pain reduction), and the proportion of patients feeling "Much" or "Very Much" improved on the Patient Global Impression of Change (PGIC).

RESULTS

Compared with placebo, patients in both age subgroups treated with G-GR (placebo/G-GR) had greater reductions in mean ADP (≥75: -21.9/-34.2 %, p = 0.0348; <75: -29.9/-38.3 %, p = 0.0079) and SIS (≥75: -1.3/-2.4, p = 0.0017; <75: -1.8/-2.7, p < 0.0001), more patients were responders (≥75: 30.4/52.0 %, p = 0.0025; <75: 45.0/54.7 %, p = 0.0265), and more felt "Much" or "Very Much" improved on the PGIC (≥75: 20.7/35.0 %, p = 0.0272; <75: 33.6/44.9 %, p = 0.0077). The most common (placebo/G-GR) adverse events (AEs) were dizziness (≥75: 3.3/12.0 %; <75: 1.8/10.4 %), nausea (≥75: 1.0/5.4 %; <75: 2.9/4.2 %), and somnolence (≥75: 0/5.0 %; <75: 3.7/4.2 %). For all patients, AEs rapidly decreased to low steady levels after 4-5 weeks of treatment. The incidence of serious AEs was low and they were reported more frequently in the placebo than in the G-GR group.

CONCLUSIONS

Therapy with once-daily G-GR was as effective for treating pain associated with PHN in elderly patients as it was in younger patients. G-GR was well tolerated, and the incidence of the most common AEs did not appear to be age related.

Authors+Show Affiliations

University Pain Institute, Division of Pain Medicine & Regional Anesthesiology, Department of Anesthesiology and Perioperative Medicine, Drexel University College of Medicine, 245 North 15th Street, New College Building, MS 310, Philadelphia, PA, 19102, USA, anita.gupta@drexelmed.edu.No affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24163280

Citation

Gupta, Anita, and Sean Li. "Safety and Efficacy of Once-daily Gastroretentive Gabapentin in Patients With Postherpetic Neuralgia Aged 75 Years and Over." Drugs & Aging, vol. 30, no. 12, 2013, pp. 999-1008.
Gupta A, Li S. Safety and efficacy of once-daily gastroretentive gabapentin in patients with postherpetic neuralgia aged 75 years and over. Drugs Aging. 2013;30(12):999-1008.
Gupta, A., & Li, S. (2013). Safety and efficacy of once-daily gastroretentive gabapentin in patients with postherpetic neuralgia aged 75 years and over. Drugs & Aging, 30(12), 999-1008. https://doi.org/10.1007/s40266-013-0126-4
Gupta A, Li S. Safety and Efficacy of Once-daily Gastroretentive Gabapentin in Patients With Postherpetic Neuralgia Aged 75 Years and Over. Drugs Aging. 2013;30(12):999-1008. PubMed PMID: 24163280.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of once-daily gastroretentive gabapentin in patients with postherpetic neuralgia aged 75 years and over. AU - Gupta,Anita, AU - Li,Sean, PY - 2013/10/29/entrez PY - 2013/10/29/pubmed PY - 2014/7/8/medline SP - 999 EP - 1008 JF - Drugs & aging JO - Drugs Aging VL - 30 IS - 12 N2 - BACKGROUND: Treatment of postherpetic neuralgia (PHN) is more complicated in elderly patients, and multiple daily dosing, complex titration, and high incidences of adverse events can be limiting for many pharmacological treatment options. OBJECTIVE: The aim of this study was to determine whether the efficacy and tolerability of once-daily gastroretentive gabapentin (G-GR) is similar between elderly patients (≥75 years) and younger patients (<75 years). METHODS: Data from two phase III, placebo-controlled studies of 1,800 mg G-GR once daily with dinner in patients with PHN were integrated and analyzed by age subgroups (<75 years, n = 527; ≥75 years, n = 192). Efficacy assessments at endpoint (week 10) included baseline-adjusted change in average daily pain (ADP) and average daily sleep interference (SIS) scores, the proportion of responders (≥30 % pain reduction), and the proportion of patients feeling "Much" or "Very Much" improved on the Patient Global Impression of Change (PGIC). RESULTS: Compared with placebo, patients in both age subgroups treated with G-GR (placebo/G-GR) had greater reductions in mean ADP (≥75: -21.9/-34.2 %, p = 0.0348; <75: -29.9/-38.3 %, p = 0.0079) and SIS (≥75: -1.3/-2.4, p = 0.0017; <75: -1.8/-2.7, p < 0.0001), more patients were responders (≥75: 30.4/52.0 %, p = 0.0025; <75: 45.0/54.7 %, p = 0.0265), and more felt "Much" or "Very Much" improved on the PGIC (≥75: 20.7/35.0 %, p = 0.0272; <75: 33.6/44.9 %, p = 0.0077). The most common (placebo/G-GR) adverse events (AEs) were dizziness (≥75: 3.3/12.0 %; <75: 1.8/10.4 %), nausea (≥75: 1.0/5.4 %; <75: 2.9/4.2 %), and somnolence (≥75: 0/5.0 %; <75: 3.7/4.2 %). For all patients, AEs rapidly decreased to low steady levels after 4-5 weeks of treatment. The incidence of serious AEs was low and they were reported more frequently in the placebo than in the G-GR group. CONCLUSIONS: Therapy with once-daily G-GR was as effective for treating pain associated with PHN in elderly patients as it was in younger patients. G-GR was well tolerated, and the incidence of the most common AEs did not appear to be age related. SN - 1179-1969 UR - https://www.unboundmedicine.com/medline/citation/24163280/Safety_and_efficacy_of_once_daily_gastroretentive_gabapentin_in_patients_with_postherpetic_neuralgia_aged_75_years_and_over_ L2 - https://dx.doi.org/10.1007/s40266-013-0126-4 DB - PRIME DP - Unbound Medicine ER -