PMID- 24163280
OWN - NLM
STAT- MEDLINE
DCOM- 20140707
LR  - 20211021
IS  - 1179-1969 (Electronic)
IS  - 1170-229X (Print)
IS  - 1170-229X (Linking)
VI  - 30
IP  - 12
DP  - 2013 Dec
TI  - Safety and efficacy of once-daily gastroretentive gabapentin in patients with 
      postherpetic neuralgia aged 75 years and over.
PG  - 999-1008
LID - 10.1007/s40266-013-0126-4 [doi]
AB  - 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.
FAU - Gupta, Anita
AU  - Gupta A
AD  - 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.
FAU - Li, Sean
AU  - Li S
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drugs Aging
JT  - Drugs & aging
JID - 9102074
RN  - 0 (Amines)
RN  - 0 (Analgesics)
RN  - 0 (Cyclohexanecarboxylic Acids)
RN  - 0 (Delayed-Action Preparations)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
RN  - 6CW7F3G59X (Gabapentin)
SB  - IM
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Amines/administration & dosage/*adverse effects/pharmacokinetics/*therapeutic use
MH  - Analgesics/administration & dosage/*adverse effects/pharmacokinetics/*therapeutic 
      use
MH  - Cyclohexanecarboxylic Acids/administration & dosage/*adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Delayed-Action Preparations
MH  - Drug Administration Schedule
MH  - Female
MH  - Gabapentin
MH  - Gastric Mucosa/*metabolism
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/*drug therapy
MH  - Tissue Distribution
MH  - Treatment Outcome
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/administration & dosage/*adverse 
      effects/pharmacokinetics/*therapeutic use
PMC - PMC3832771
EDAT- 2013/10/29 06:00
MHDA- 2014/07/08 06:00
PMCR- 2013/10/26
CRDT- 2013/10/29 06:00
PHST- 2013/10/29 06:00 [entrez]
PHST- 2013/10/29 06:00 [pubmed]
PHST- 2014/07/08 06:00 [medline]
PHST- 2013/10/26 00:00 [pmc-release]
AID - 126 [pii]
AID - 10.1007/s40266-013-0126-4 [doi]
PST - ppublish
SO  - Drugs Aging. 2013 Dec;30(12):999-1008. doi: 10.1007/s40266-013-0126-4.