PMID- 23370075
OWN - NLM
STAT- MEDLINE
DCOM- 20140228
LR  - 20181202
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Linking)
VI  - 29
IP  - 9
DP  - 2013 Sep
TI  - Long-term safety of gastroretentive gabapentin in postherpetic neuralgia 
      patients.
PG  - 770-4
LID - 10.1097/AJP.0b013e31827b32ab [doi]
AB  - OBJECTIVE: This study evaluated the long-term safety and tolerability of a 
      gastroretentive formulation of gabapentin (G-GR) and its effect on weight gain in 
      postherpetic neuralgia (PHN) patients participating in a 14-week, open-label 
      extension to a 10-week double-blind study. METHODS: Patients with PHN >/= 3 months, 
      who had completed participation in a phase 3 randomized, double-blind, 
      placebo-controlled study of the safety and efficacy of G-GR in PHN, who wished to 
      continue treatment with G-GR, and who the investigator thought would benefit from 
      study participation received G-GR 1800 mg as an asymmetrically divided dose (600 
      mg AM/1200 mg PM) for an additional 14 weeks. Analyses were performed on safety 
      data from patients who received G-GR for 10 weeks in the randomized controlled 
      study and who then received an additional 14 weeks of G-GR, asymmetrically dosed 
      in the current study. Safety assessments included the incidence and severity of 
      adverse events (AEs), the occurrence of serious AEs, changes in physical and 
      neurological examination findings, clinical laboratory assessments, and changes 
      in weight. RESULTS: Eighty patients treated with G-GR in the randomized, 
      controlled study participated in this 14-week extension study. The incidence of 
      AEs commonly observed with gabapentin (dizziness, somnolence) was low and the 
      frequency, intensity, and severity of AEs did not change with long-term 
      treatment. The mean weight change from baseline in the randomized controlled 
      study to the end of the extension study was +0.76 kg. Weight increase was 
      reported as an AE for 2 (2.5%) patients. CONCLUSIONS: Long-term treatment (up to 
      24 wk) with G-GR of 1800 mg was well tolerated and associated with little weight 
      gain (< 1 kg) in patients with PHN. No new safety issues emerged with G-GR 
      long-term treatment.
FAU - Jensen, Mark P
AU  - Jensen MP
AD  - Department of Rehabilitation Medicine, Harborview Medical Center, University of 
      Washington School of Medicine, Seattle, WA 98104, USA. mjensen@uw.edu
FAU - Irving, Gordon
AU  - Irving G
FAU - Rauck, Richard
AU  - Rauck R
FAU - Wallace, Mark
AU  - Wallace M
FAU - Sweeney, Mike
AU  - Sweeney M
FAU - Vanhove, Geertrui F
AU  - Vanhove GF
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin J Pain
JT  - The Clinical journal of pain
JID - 8507389
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  - Aged
MH  - Aged, 80 and over
MH  - Amines/*administration & dosage
MH  - Analgesics/*administration & dosage
MH  - Cyclohexanecarboxylic Acids/*administration & dosage
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Gabapentin
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/*drug therapy
MH  - Pain Measurement
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/*administration & dosage
EDAT- 2013/02/02 06:00
MHDA- 2014/03/01 06:00
CRDT- 2013/02/02 06:00
PHST- 2013/02/02 06:00 [entrez]
PHST- 2013/02/02 06:00 [pubmed]
PHST- 2014/03/01 06:00 [medline]
AID - 10.1097/AJP.0b013e31827b32ab [doi]
PST - ppublish
SO  - Clin J Pain. 2013 Sep;29(9):770-4. doi: 10.1097/AJP.0b013e31827b32ab.