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Real-world experience with once-daily gabapentin for the treatment of postherpetic neuralgia (PHN).

Markley HG, Dunteman ED, Kareht S, Sweeney M - Clin J Pain (2015)

Bottom Line: The proportion of patients with a ≥30% reduction in VAS score from baseline was 51.8%/55.0% (70 y and below/above 70 y) and was 42.7%/37.5% for a ≥50% reduction.Brief Pain Inventory scores were all significantly reduced by week 8.G-GR was generally well tolerated.

View Article: PubMed Central - PubMed

Affiliation: *New England Regional Headache Center, Worcester, MA †A&A Pain Institute of St. Louis, St. Louis, MO ‡Depomed Inc., Newark, CA.

ABSTRACT

Objectives: To evaluate the safety and effectiveness of once-daily gastroretentive gabapentin (G-GR) for the treatment of postherpetic neuralgia in real-world clinical practice.

Materials and methods: Patients aged 18 years and above were divided into 2 cohorts: patients aged 70 years and below and patients above 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. Patient/Clinician Global Impression of Change scales were completed at week 8. Adverse events (AEs) were assessed.

Results: The efficacy population included 190 patients (110, 70 y and below; 80, above 70 y). The mean percent change in VAS score at week 8 from baseline was -21.3%/-20.4% (70 y and below/above 70 y). The proportion of patients with a ≥30% reduction in VAS score from baseline was 51.8%/55.0% (70 y and below/above 70 y) and was 42.7%/37.5% for a ≥50% reduction. Brief Pain Inventory scores were all significantly reduced by week 8. On the Patient Global Impression of Change instrument, more patients aged 70 years and below 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 and below/above 70 y) were dizziness (11.7%/16.3%) and somnolence (3.6%/8.1%).

Discussion: In real-world clinical practice, G-GR seems to be an effective, well-tolerated treatment option for patients with postherpetic neuralgia, regardless of age.

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Related in: MedlinePlus

Prevalence of adverse events (AEs) over time. AEs were recorded at the week 2 and week 8 study visits, and during the posttapering phone visit by the week during which they occurred. The titration period comprised the first 2 weeks of the study.
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Figure 5: Prevalence of adverse events (AEs) over time. AEs were recorded at the week 2 and week 8 study visits, and during the posttapering phone visit by the week during which they occurred. The titration period comprised the first 2 weeks of the study.

Mentions: A total of 100 (50.8%) patients in the study experienced an AE and 32% of patients experienced at least 1 G-GR-related AE (Table 4). The G-GR-related AEs experienced by ≥3% of patients were nervous system and gastrointestinal disorders. For the total population, these included dizziness (13.7%), somnolence (5.6%), nausea (3.6%), headache (3.6%), and diarrhea (2.6%) (Fig. 4). The prevalence of these AEs decreased rapidly, and by the end of the titration period had reached sustained levels under 2% (Fig. 5).


Real-world experience with once-daily gabapentin for the treatment of postherpetic neuralgia (PHN).

Markley HG, Dunteman ED, Kareht S, Sweeney M - Clin J Pain (2015)

Prevalence of adverse events (AEs) over time. AEs were recorded at the week 2 and week 8 study visits, and during the posttapering phone visit by the week during which they occurred. The titration period comprised the first 2 weeks of the study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4257585&req=5

Figure 5: Prevalence of adverse events (AEs) over time. AEs were recorded at the week 2 and week 8 study visits, and during the posttapering phone visit by the week during which they occurred. The titration period comprised the first 2 weeks of the study.
Mentions: A total of 100 (50.8%) patients in the study experienced an AE and 32% of patients experienced at least 1 G-GR-related AE (Table 4). The G-GR-related AEs experienced by ≥3% of patients were nervous system and gastrointestinal disorders. For the total population, these included dizziness (13.7%), somnolence (5.6%), nausea (3.6%), headache (3.6%), and diarrhea (2.6%) (Fig. 4). The prevalence of these AEs decreased rapidly, and by the end of the titration period had reached sustained levels under 2% (Fig. 5).

Bottom Line: The proportion of patients with a ≥30% reduction in VAS score from baseline was 51.8%/55.0% (70 y and below/above 70 y) and was 42.7%/37.5% for a ≥50% reduction.Brief Pain Inventory scores were all significantly reduced by week 8.G-GR was generally well tolerated.

View Article: PubMed Central - PubMed

Affiliation: *New England Regional Headache Center, Worcester, MA †A&A Pain Institute of St. Louis, St. Louis, MO ‡Depomed Inc., Newark, CA.

ABSTRACT

Objectives: To evaluate the safety and effectiveness of once-daily gastroretentive gabapentin (G-GR) for the treatment of postherpetic neuralgia in real-world clinical practice.

Materials and methods: Patients aged 18 years and above were divided into 2 cohorts: patients aged 70 years and below and patients above 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. Patient/Clinician Global Impression of Change scales were completed at week 8. Adverse events (AEs) were assessed.

Results: The efficacy population included 190 patients (110, 70 y and below; 80, above 70 y). The mean percent change in VAS score at week 8 from baseline was -21.3%/-20.4% (70 y and below/above 70 y). The proportion of patients with a ≥30% reduction in VAS score from baseline was 51.8%/55.0% (70 y and below/above 70 y) and was 42.7%/37.5% for a ≥50% reduction. Brief Pain Inventory scores were all significantly reduced by week 8. On the Patient Global Impression of Change instrument, more patients aged 70 years and below 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 and below/above 70 y) were dizziness (11.7%/16.3%) and somnolence (3.6%/8.1%).

Discussion: In real-world clinical practice, G-GR seems to be an effective, well-tolerated treatment option for patients with postherpetic neuralgia, regardless of age.

Show MeSH
Related in: MedlinePlus