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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

Incidence of common adverse events with pregabalin. Numbers of the most common adverse events, either appearing for the first time or worsening in severity, by week for the first 6 weeks. 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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f3-jpr-8-303: Incidence of common adverse events with pregabalin. Numbers of the most common adverse events, either appearing for the first time or worsening in severity, by week for the first 6 weeks. 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 most common AEs (and their incidences) with pregabalin over the entire duration of the trials were dizziness (14.4%), peripheral edema (9.2%), somnolence (7.2%), and increased weight (6.3%).20,21 The majority of these instances of AEs emerged within 3–4 weeks of treatment with pregabalin, with the exception of peripheral edema, where the incidence was similar at each week from weeks 2–6 (Figure 3A).


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)

Incidence of common adverse events with pregabalin. Numbers of the most common adverse events, either appearing for the first time or worsening in severity, by week for the first 6 weeks. 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

f3-jpr-8-303: Incidence of common adverse events with pregabalin. Numbers of the most common adverse events, either appearing for the first time or worsening in severity, by week for the first 6 weeks. 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 most common AEs (and their incidences) with pregabalin over the entire duration of the trials were dizziness (14.4%), peripheral edema (9.2%), somnolence (7.2%), and increased weight (6.3%).20,21 The majority of these instances of AEs emerged within 3–4 weeks of treatment with pregabalin, with the exception of peripheral edema, where the incidence was similar at each week from weeks 2–6 (Figure 3A).

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