Objectives: To evaluate the safety and effectiveness of once-daily gastroretentive gabapentin (G-GR) for treatment of PHN in real-world clinical practice.
Methods: Patients aged >=18 years were divided into 2 cohorts: patients <=70 years and patients >70 years. All patients were titrated to 1800 mg G-GR/d over 2 weeks and maintained at that dosage for 6 weeks, for 8 weeks total treatment. To reflect clinical practice, exclusion criteria were limited to those in the product label. Efficacy was assessed using a visual analog scale (VAS) and the Brief Pain Inventory (BPI). Patient/Clinician Global Impression of Change (PGIC/CGIC) scales were completed at Week 8. Adverse events (AEs) were assessed.
Results: The efficacy population included 190 patients (110, <=70 y; 80, >70 y). The mean percent change in VAS score at Week 8 from baseline was -21.3%/-20.4% (<=70 y/>70 y). The proportion of patients with a >=30% reduction in VAS score from baseline was 51.8%/55.0% (<=70 y/>70 y) and was 42.7%/37.5% for a >=50% reduction. BPI scores were all significantly reduced by Week 8. On the PGIC instrument, more patients <=70 years reported feeling "Much" or "Very much" improved from baseline (59.0% vs. 40.3%). G-GR was generally well tolerated. Thirty-seven (18.8%) patients experienced AEs that led to discontinuation. No patients died and 5 (2.5%) patients experienced serious AEs. The most common G-GR-related AEs (<=70 y/>70 y) were dizziness (11.7%/16.3%) and somnolence (3.6%/8.1%).
Discussion: In real-world clinical practice, G-GR appears to be an effective, well-tolerated treatment option for patients with PHN, regardless of age.
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