Relationships among adverse events, disease characteristics, and demographics in treatment of postherpetic neuralgia with gastroretentive gabapentin

Naum Shaparin, Patricia W. Slattum, Iwona Bucior, Srinivas Nalamachu

Research output: Contribution to journalArticle

Abstract

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 1800mg 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 (Pr0.0001) 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.

Original languageEnglish (US)
Pages (from-to)983-991
Number of pages9
JournalClinical Journal of Pain
Volume31
Issue number11
DOIs
StatePublished - 2015

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Postherpetic Neuralgia
Demography
Therapeutics
Safety
Incidence
gabapentin
Logistic Models
Regression Analysis

Keywords

  • gabapentin
  • gastroretentive
  • neuropathic pain
  • Postherpetic neuralgia
  • safety

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Clinical Neurology

Cite this

Relationships among adverse events, disease characteristics, and demographics in treatment of postherpetic neuralgia with gastroretentive gabapentin. / Shaparin, Naum; Slattum, Patricia W.; Bucior, Iwona; Nalamachu, Srinivas.

In: Clinical Journal of Pain, Vol. 31, No. 11, 2015, p. 983-991.

Research output: Contribution to journalArticle

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abstract = "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 1800mg 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 (Pr0.0001) 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.",
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