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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

Percentage of patients with a ≥30%, ≥50%, or ≥20 mm reduction in the Visual Analog Scale (VAS) from baseline to Week 8, LOCF. Patients were groups as All, ≤70 years, and >70 years.
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Figure 1: Percentage of patients with a ≥30%, ≥50%, or ≥20 mm reduction in the Visual Analog Scale (VAS) from baseline to Week 8, LOCF. Patients were groups as All, ≤70 years, and >70 years.

Mentions: Nearly half (45.8%) of all the patients had a ≥30% reduction in VAS score from baseline to week 2, and 53.2% had ≥30% reduction in VAS score at week 8 (Fig. 1). The proportion of patients who had a ≥50% reduction in VAS score from baseline was 33.2% at week 2 and 40.5% at week 8, and 37.4% of patients had a reduction in VAS score from baseline of ≥20 mm at week 2, which increased to 51.1% by week 8. Analysis of VAS responders at week 8 by age revealed very similar changes in VAS scores from baseline for the 2 age subgroups (70 y and below vs. above 70 y): 51.8% versus 55.0% had a ≥30% reduction; 42.7% versus 37.5% had a ≥50% reduction; and 47.3% versus 56.3% had a reduction of ≥20 mm (Fig. 1).


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)

Percentage of patients with a ≥30%, ≥50%, or ≥20 mm reduction in the Visual Analog Scale (VAS) from baseline to Week 8, LOCF. Patients were groups as All, ≤70 years, and >70 years.
© Copyright Policy
Related In: Results  -  Collection

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

Figure 1: Percentage of patients with a ≥30%, ≥50%, or ≥20 mm reduction in the Visual Analog Scale (VAS) from baseline to Week 8, LOCF. Patients were groups as All, ≤70 years, and >70 years.
Mentions: Nearly half (45.8%) of all the patients had a ≥30% reduction in VAS score from baseline to week 2, and 53.2% had ≥30% reduction in VAS score at week 8 (Fig. 1). The proportion of patients who had a ≥50% reduction in VAS score from baseline was 33.2% at week 2 and 40.5% at week 8, and 37.4% of patients had a reduction in VAS score from baseline of ≥20 mm at week 2, which increased to 51.1% by week 8. Analysis of VAS responders at week 8 by age revealed very similar changes in VAS scores from baseline for the 2 age subgroups (70 y and below vs. above 70 y): 51.8% versus 55.0% had a ≥30% reduction; 42.7% versus 37.5% had a ≥50% reduction; and 47.3% versus 56.3% had a reduction of ≥20 mm (Fig. 1).

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