PMID- 25811794
OWN - NLM
STAT- MEDLINE
DCOM- 20160701
LR  - 20181202
IS  - 1536-5409 (Electronic)
IS  - 0749-8047 (Print)
IS  - 0749-8047 (Linking)
VI  - 31
IP  - 11
DP  - 2015 Nov
TI  - Relationships Among Adverse Events, Disease Characteristics, and Demographics in 
      Treatment of Postherpetic Neuralgia With Gastroretentive Gabapentin.
PG  - 983-91
LID - 10.1097/AJP.0000000000000206 [doi]
AB  - OBJECTIVES: To characterize risk factors for occurrence of adverse events (AEs) 
      and treatment discontinuations due to AEs for improving safety and tolerability 
      of treatment of postherpetic neuralgia (PHN). METHODS: Patients with PHN (n=556) 
      received 1800 mg once-daily gastroretentive gabapentin (G-GR) in 2 phase 3 and 1 
      phase 4 study. Safety assessments included the incidence and severity of AEs and 
      analysis of discontinuations due to AEs. Multivariable, logistic regression 
      analyses examined predictors of AE reporting and discontinuations due to AEs. 
      RESULTS: In total, 53.2% of patients reported any AE, and 12.9% discontinued 
      because of AEs. Both AE incidence and treatment discontinuations decreased 
      rapidly during the 2-week titration to sustained, low levels. The probability to 
      report any AE was 0.6 for females versus 0.4 for males, whereas there were no 
      differences in probabilities for age (less than 75 vs. 75 y and older) and race 
      (nonwhite vs. white). Consistent with this, only female sex was a significant 
      (P=0.0006) predictor of AE reporting. Experiencing moderate (P</=0.0001) or severe 
      (P=0.0006) AEs, but not patient demographics, was predictive of treatment 
      discontinuations. The probability of discontinuation due to moderate AEs was 0.4 
      and 0.5 for severe AEs. DISCUSSION: The tolerability of G-GR was not affected by 
      patient age, but was affected by AE severity. Although being female was 
      predictive of reporting AEs, it did not influence treatment discontinuation. 
      Given that PHN is a disease for which the risk and duration of PHN increases with 
      age and with being female, G-GR appears to be a well-suited treatment option for 
      PHN.
FAU - Shaparin, Naum
AU  - Shaparin N
AD  - *Montefiore Pain Center, Bronx, NY daggerVirginia Commonwealth University, Department 
      of Gerontology, Richmond, VA double daggerDepomed Inc., Newark, CA  section signInternational Clinical 
      Research Institute, Overland Park, KS.
FAU - Slattum, Patricia W
AU  - Slattum PW
FAU - Bucior, Iwona
AU  - Bucior I
FAU - Nalamachu, Srinivas
AU  - Nalamachu S
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Randomized Controlled Trial
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  - 56-12-2 (gamma-Aminobutyric Acid)
RN  - 6CW7F3G59X (Gabapentin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Amines/*adverse effects/therapeutic use
MH  - Analgesics/*adverse effects/therapeutic use
MH  - Cyclohexanecarboxylic Acids/*adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Gabapentin
MH  - Humans
MH  - Incidence
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Neuralgia, Postherpetic/*drug therapy/*epidemiology
MH  - Pain Measurement
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Sex Factors
MH  - Treatment Outcome
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/*adverse effects/therapeutic use
PMC - PMC4894771
COIS- Supported by Depomed Inc., Newark, CA. I.B. is an employee and shareholder of 
      Depomed Inc. The remaining authors declare no conflict of interest.
EDAT- 2015/03/27 06:00
MHDA- 2016/07/02 06:00
PMCR- 2016/06/06
CRDT- 2015/03/27 06:00
PHST- 2015/03/27 06:00 [entrez]
PHST- 2015/03/27 06:00 [pubmed]
PHST- 2016/07/02 06:00 [medline]
PHST- 2016/06/06 00:00 [pmc-release]
AID - 10.1097/AJP.0000000000000206 [doi]
PST - ppublish
SO  - Clin J Pain. 2015 Nov;31(11):983-91. doi: 10.1097/AJP.0000000000000206.