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Temporal analysis of pain responders and common adverse events: when do these first appear following treatment with pregabalin.

Parsons B, Emir B, Clair A - J Pain Res (2015)

Bottom Line: The emergence of adverse events at each week was also recorded.The majority of common adverse events also emerged within the first 3-4 weeks of pregabalin treatment.These data suggest that the majority of pain responders and common adverse events emerge within 3-4 weeks of treatment with pregabalin.

View Article: PubMed Central - PubMed

Affiliation: Pfizer, New York, NY, USA.

ABSTRACT

Background: Pregabalin is an α2δ ligand indicated in the USA for treatment of a number of chronic pain conditions, including diabetic peripheral neuropathy, postherpetic neuralgia, pain associated with spinal cord injury, and fibromyalgia. A greater understanding of when patients first respond to treatment with pregabalin and when adverse events emerge, or worsen, could aid design of new proof-of-concept studies and help guide treatment of patients.

Methods: This was an analysis of five randomized, placebo-controlled, double-blind trials (between 8 and 16 weeks in duration) of flexible-dose pregabalin (150-600 mg/day). Individual patient data were pooled into three groups by disease condition: diabetic peripheral neuropathy or postherpetic neuralgia (n=514), spinal cord injury (n=356), and fibromyalgia (n=498). Responders were classified as having a ≥30% and/or ≥50% reduction in mean pain score from baseline; once a patient responded, they were not scored subsequently (and were excluded from the responder analysis). The emergence of adverse events at each week was also recorded.

Results: The majority of the 30% and 50% responders emerged within the first 3-4 weeks with pregabalin, but were more uniformly distributed across the 6 weeks of the analysis with placebo. The majority of common adverse events also emerged within the first 3-4 weeks of pregabalin treatment.

Conclusion: These data suggest that the majority of pain responders and common adverse events emerge within 3-4 weeks of treatment with pregabalin. These data could advise new proof-of-concept studies and guide clinical management.

No MeSH data available.


Related in: MedlinePlus

Thirty percent responders by week with pregabalin and placebo. Responders had a 30% reduction in mean pain score. Once a patient responded, they were not scored subsequently and were excluded from the analysis. Data are shown for patients with (A) DPN/PHN, (B) SCI, and (C) FM.Abbreviations: DPN, diabetic peripheral neuropathy; FM, fibromyalgia; PHN, postherpetic neuralgia; SCI, spinal cord injury.
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f1-jpr-8-303: Thirty percent responders by week with pregabalin and placebo. Responders had a 30% reduction in mean pain score. Once a patient responded, they were not scored subsequently and were excluded from the analysis. Data are shown for patients with (A) DPN/PHN, (B) SCI, and (C) FM.Abbreviations: DPN, diabetic peripheral neuropathy; FM, fibromyalgia; PHN, postherpetic neuralgia; SCI, spinal cord injury.

Mentions: In patients with DPN/PHN, the number of 30% responders peaked at week 3 with pregabalin (15.0%, 22.1%, 26.8%, and 19.1% by week for weeks 1–4, respectively) and week 4 with placebo (5.4%, 15.6%, 19.5%, and 24.2% for weeks 1–4, respectively, Figure 1A). In total, 231 patients (66.8%) with pregabalin and 87 (52.4%) with placebo were 30% responders after 6 weeks. The number of 50% responders peaked at 3 weeks with pregabalin (5.5%, 9.1%, 12.9%, and 10.6% for weeks 1–4, respectively) and 4 weeks with placebo (0.6%, 4.9%, 8.2%, and 12.6% for weeks 1–4, respectively, Figure 2A). In total, 144 patients (41.6%) with pregabalin and 51 (30.7%) with placebo were 50% responders in the 6-week analysis.


Temporal analysis of pain responders and common adverse events: when do these first appear following treatment with pregabalin.

Parsons B, Emir B, Clair A - J Pain Res (2015)

Thirty percent responders by week with pregabalin and placebo. Responders had a 30% reduction in mean pain score. Once a patient responded, they were not scored subsequently and were excluded from the analysis. Data are shown for patients with (A) DPN/PHN, (B) SCI, and (C) FM.Abbreviations: DPN, diabetic peripheral neuropathy; FM, fibromyalgia; PHN, postherpetic neuralgia; SCI, spinal cord injury.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494606&req=5

f1-jpr-8-303: Thirty percent responders by week with pregabalin and placebo. Responders had a 30% reduction in mean pain score. Once a patient responded, they were not scored subsequently and were excluded from the analysis. Data are shown for patients with (A) DPN/PHN, (B) SCI, and (C) FM.Abbreviations: DPN, diabetic peripheral neuropathy; FM, fibromyalgia; PHN, postherpetic neuralgia; SCI, spinal cord injury.
Mentions: In patients with DPN/PHN, the number of 30% responders peaked at week 3 with pregabalin (15.0%, 22.1%, 26.8%, and 19.1% by week for weeks 1–4, respectively) and week 4 with placebo (5.4%, 15.6%, 19.5%, and 24.2% for weeks 1–4, respectively, Figure 1A). In total, 231 patients (66.8%) with pregabalin and 87 (52.4%) with placebo were 30% responders after 6 weeks. The number of 50% responders peaked at 3 weeks with pregabalin (5.5%, 9.1%, 12.9%, and 10.6% for weeks 1–4, respectively) and 4 weeks with placebo (0.6%, 4.9%, 8.2%, and 12.6% for weeks 1–4, respectively, Figure 2A). In total, 144 patients (41.6%) with pregabalin and 51 (30.7%) with placebo were 50% responders in the 6-week analysis.

Bottom Line: The emergence of adverse events at each week was also recorded.The majority of common adverse events also emerged within the first 3-4 weeks of pregabalin treatment.These data suggest that the majority of pain responders and common adverse events emerge within 3-4 weeks of treatment with pregabalin.

View Article: PubMed Central - PubMed

Affiliation: Pfizer, New York, NY, USA.

ABSTRACT

Background: Pregabalin is an α2δ ligand indicated in the USA for treatment of a number of chronic pain conditions, including diabetic peripheral neuropathy, postherpetic neuralgia, pain associated with spinal cord injury, and fibromyalgia. A greater understanding of when patients first respond to treatment with pregabalin and when adverse events emerge, or worsen, could aid design of new proof-of-concept studies and help guide treatment of patients.

Methods: This was an analysis of five randomized, placebo-controlled, double-blind trials (between 8 and 16 weeks in duration) of flexible-dose pregabalin (150-600 mg/day). Individual patient data were pooled into three groups by disease condition: diabetic peripheral neuropathy or postherpetic neuralgia (n=514), spinal cord injury (n=356), and fibromyalgia (n=498). Responders were classified as having a ≥30% and/or ≥50% reduction in mean pain score from baseline; once a patient responded, they were not scored subsequently (and were excluded from the responder analysis). The emergence of adverse events at each week was also recorded.

Results: The majority of the 30% and 50% responders emerged within the first 3-4 weeks with pregabalin, but were more uniformly distributed across the 6 weeks of the analysis with placebo. The majority of common adverse events also emerged within the first 3-4 weeks of pregabalin treatment.

Conclusion: These data suggest that the majority of pain responders and common adverse events emerge within 3-4 weeks of treatment with pregabalin. These data could advise new proof-of-concept studies and guide clinical management.

No MeSH data available.


Related in: MedlinePlus