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 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.