title: Relationships Among Adverse Events, Disease Characteristics, and Demographics in Treatment of Postherpetic Neuralgia With Gastroretentive Gabapentin.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors: *Montefiore Pain Center, Bronx, NY †Virginia Commonwealth University, Department of Gerontology, Richmond, VA ‡Depomed Inc., Newark, CA §International Clinical Research Institute, Overland Park, KS.
authors: Naum
authors: N
authors: Shaparin
authors: Patricia W
authors: PW
authors: Slattum
authors: Iwona
authors: I
authors: Bucior
authors: Srinivas
authors: S
authors: Nalamachu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000588:Amines / Q000009:adverse effects* / Q000627:therapeutic use; D000700:Analgesics / Q000009:adverse effects* / Q000627:therapeutic use; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D000077206:Gabapentin; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D051474:Neuralgia, Postherpetic / Q000188:drug therapy* / Q000453:epidemiology*; D010147:Pain Measurement; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin