PMID- 22792006
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20240417
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 5
DP  - 2012
TI  - Tolerability and safety of gastroretentive once-daily gabapentin tablets for the 
      treatment of postherpetic neuralgia.
PG  - 203-8
LID - 10.2147/JPR.S32562 [doi]
AB  - OBJECTIVE: An immediate-release formulation of gabapentin is approved for 
      treatment of postherpetic neuralgia (PHN). This formulation, however, requires 
      multiple daily dosing, usually three times per day, and is associated with a high 
      incidence of somnolence and dizziness. We assessed the tolerability and safety of 
      a once-daily gastroretentive formulation of gabapentin (G-GR) in phase 3 clinical 
      trials in patients with PHN. RESEARCH DESIGN AND METHODS: Data were pooled from 
      two placebo-controlled studies involving 723 patients (G-GR 1800 mg, n = 359; 
      placebo, n = 364). Patients (43% male, mean age 66 years) with PHN pain >4 (0-10 
      scale) for >/=3 months were enrolled. Summary statistics for the incidence of 
      treatment-emergent adverse events (AEs) were performed. Laboratory parameters and 
      vital signs were assessed. RESULTS: Treatment-emergent AEs were reported in 48% 
      of patients (G-GR, 54%; placebo, 42%) and led to discontinuation in 8% of 
      patients (G-GR, 10%; placebo, 7%). The most frequent (>/=3% in any group) AEs were 
      dizziness (G-GR, 11%; placebo, 2%), somnolence (G-GR, 5%; placebo, 3%), headache 
      (G-GR, 4%; placebo, 4%), peripheral edema (G-GR, 4%; placebo, <1%), and diarrhea 
      (G-GR, 3%; placebo, 3%). Serious AEs were reported in seven patients in the G-GR 
      group (2%) and ten patients in the placebo group (3%). There were two deaths, 
      both in the placebo group. No serious AEs were considered related to treatment. 
      Mean values for laboratory parameters and vital signs at the end of each study 
      were similar between groups. CONCLUSION: G-GR was safe and well tolerated for the 
      treatment of PHN.
FAU - Irving, Gordon A
AU  - Irving GA
AD  - Swedish Pain and Headache Center, Seattle, WA, USA.
FAU - Sweeney, Michael
AU  - Sweeney M
LA  - eng
PT  - Journal Article
DEP - 20120625
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC3392710
OTO - NOTNLM
OT  - adverse events
OT  - dizziness
OT  - gabapentin
OT  - gastroretentive
OT  - postherpetic neuralgia
OT  - somnolence
EDAT- 2012/07/14 06:00
MHDA- 2012/07/14 06:01
PMCR- 2012/06/25
CRDT- 2012/07/14 06:00
PHST- 2012/07/14 06:00 [entrez]
PHST- 2012/07/14 06:00 [pubmed]
PHST- 2012/07/14 06:01 [medline]
PHST- 2012/06/25 00:00 [pmc-release]
AID - jpr-5-203 [pii]
AID - 10.2147/JPR.S32562 [doi]
PST - ppublish
SO  - J Pain Res. 2012;5:203-8. doi: 10.2147/JPR.S32562. Epub 2012 Jun 25.