PMID- 20818838
OWN - NLM
STAT- MEDLINE
DCOM- 20101215
LR  - 20220331
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 30
IP  - 11
DP  - 2010
TI  - Gabapentin extended-release tablets for the treatment of patients with 
      postherpetic neuralgia: a randomized, double-blind, placebo-controlled, 
      multicentre study.
PG  - 765-76
LID - 10.2165/11539520-000000000-00000 [doi]
AB  - BACKGROUND: Postherpetic neuralgia (PHN) is a neuropathic pain syndrome that may 
      develop subsequent to healing of herpes zoster rash. OBJECTIVES: This study aimed 
      to determine the efficacy and safety of gabapentin extended-release (gabapentin 
      ER) tablets for the treatment of patients with PHN and to determine whether 
      optimal benefits might be achieved with once-daily (QD) or divided-dose (DD) 
      administration. METHODS: This was a 10-week, randomized, double-blind, 
      placebo-controlled, multicentre trial comparing gabapentin ER (total daily dose 
      1800 mg) either QD or as an asymmetrical DD with placebo in 407 patients with 
      post-zoster pain for >or=3 months and a baseline average daily pain score 
      (ADP)>or=4 on a 0-10 Likert numerical rating scale. The primary efficacy outcome 
      was the ADP score mean change from baseline to week 10 using baseline observation 
      carried forward (BOCF). Secondary efficacy outcomes included changes to week 10 
      in last observation carried forward (LOCF) ADP score, LOCF average daily sleep 
      interference score, Short-Form McGill Pain Questionnaire score, Neuropathic Pain 
      Scale score, and Brief Pain Inventory score. RESULTS: Of 407 randomized patients, 
      400 were included in the intent-to-treat population (gabapentin ER QD, n=134; 
      gabapentin ER DD, n=135; placebo, n=131). Between-group differences in the least 
      squares (LS) mean changes in BOCF ADP scores did not reach statistical 
      significance (gabapentin ER QD -1.85 [p=0.110 vs placebo]; gabapentin ER DD -1.72 
      [p=0.255 vs placebo]; placebo -1.42). In the LOCF analysis, the LS mean ADP score 
      for the gabapentin ER QD group, but not for the DD group, improved compared with 
      placebo (gabapentin ER QD, -2.28; p=0.032 vs placebo). Improvements compared with 
      placebo were also observed in the gabapentin ER QD group, but not for the DD 
      group, for mean daily sleep interference scores (gabapentin ER QD, -2.49; 
      placebo, -1.63; p<0.001). Most adverse events (AEs) were mild or moderate. Among 
      gabapentin-treated patients, 12% and 11% withdrew due to AEs, most commonly for 
      dizziness (2% and 3%), in the gabapentin ER QD and DD groups, respectively. 
      Treatment-related AEs in the gabapentin ER-treated groups occurred in 31% of 
      patients. The most common AEs in the gabapentin ER QD and DD groups included 
      dizziness (10% and 15%), headache (4% and 7%), somnolence (3% and 7%) and 
      peripheral oedema (5% and 5%), respectively. CONCLUSION: The primary efficacy 
      endpoint for this study of gabapentin ER was not met, most likely due to the 
      unexpectedly large placebo response. Outcomes on secondary endpoints suggest the 
      potential efficacy of gabapentin ER QD. Gabapentin ER was well tolerated in this 
      study. [Clinicaltrials.gov identifier NCT00335933].
FAU - Wallace, Mark S
AU  - Wallace MS
AD  - Center for Pain Medicine, University of California, San Diego School of Medicine, 
      La Jolla, California 92037-765092093, USA. mswallace@ucsd.edu
FAU - Irving, Gordon
AU  - Irving G
FAU - Cowles, Verne E
AU  - Cowles VE
LA  - eng
SI  - ClinicalTrials.gov/NCT00335933
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Amines)
RN  - 0 (Analgesics)
RN  - 0 (Cyclohexanecarboxylic Acids)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Tablets)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
RN  - 6CW7F3G59X (Gabapentin)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Amines/*administration & dosage/adverse effects
MH  - Analgesics/*administration & dosage/adverse effects
MH  - Cyclohexanecarboxylic Acids/*administration & dosage/adverse effects
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Female
MH  - Gabapentin
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuralgia, Postherpetic/*drug therapy
MH  - Pain Measurement
MH  - Placebo Effect
MH  - Tablets
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - gamma-Aminobutyric Acid/*administration & dosage/adverse effects
EDAT- 2010/09/08 06:00
MHDA- 2010/12/16 06:00
CRDT- 2010/09/08 06:00
PHST- 2010/09/08 06:00 [entrez]
PHST- 2010/09/08 06:00 [pubmed]
PHST- 2010/12/16 06:00 [medline]
AID - 3 [pii]
AID - 10.2165/11539520-000000000-00000 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2010;30(11):765-76. doi: 10.2165/11539520-000000000-00000.