The relationship between the reporting of euphoria events and early treatment responses to pregabalin: an exploratory post-hoc analysis

Bruce Parsons, Rainer Freynhagen, Stephan Schug, Ed Whalen, Marie Ortiz, Pritha Bhadra Brown, Lloyd Knapp

Research output: Contribution to journalArticle

Abstract

Background: Euphoria is a complex, multifactorial problem that is reported as an adverse event in clinical trials of analgesics including pregabalin. The relationship between the reporting of euphoria events and pregabalin early treatment responses was examined in this exploratory post-hoc analysis.

Methods: Data were from patients with neuropathic or non-neuropathic chronic pain enrolled in 40 randomized clinical trials, who received pregabalin (75-600 mg/day) or placebo. Reports of treatment-emergent euphoria events were based on the Medical Dictionary of Regulatory Activities preferred term "euphoric mood". Prevalence rates of euphoria events overall and by indication were assessed. Post-treatment endpoints included >= 30% improvements in pain and sleep scores up to 3 weeks as well as a >= 1-point improvement in daily pain score up to 11 days after treatment.

Results: 13,252 patients were analyzed; 8,501 (64.1%) and 4,751 (35.9%) received pregabalin and placebo, respectively. Overall, 1.7% (n=222) of patients reported euphoria events. Among pregabalin-treated patients, a larger proportion who reported euphoria events achieved an early pain response compared with those who did not report euphoria (30% pain responders in week 1 with euphoria events [43.0%], without euphoria events [24.2%]). Results were similar for weeks 2 and 3. For Days 2-11, a larger proportion of pregabalin-treated patients with (relative to without) euphoria events were 1-point pain responders. Findings were similar in pregabalin-treated patients for sleep endpoints (30% sleep responders in week 1 with euphoria events [50.7%], without euphoria events [36.1%]). Similar results were found for weeks 2 and 3. Patients who received placebo showed similar patterns, although the overall number of them who reported euphoria events was small (n=13).

Conclusion: In patients who received pregabalin for neuropathic or non-neuropathic chronic pain, those who experienced euphoria events may have better early treatment responses than those who did not report euphoria events.

Original languageEnglish
Pages (from-to)2577-2587
Number of pages11
JournalJournal of Pain Research
Volume12
DOIs
Publication statusPublished - 2019

Cite this

Parsons, Bruce ; Freynhagen, Rainer ; Schug, Stephan ; Whalen, Ed ; Ortiz, Marie ; Brown, Pritha Bhadra ; Knapp, Lloyd. / The relationship between the reporting of euphoria events and early treatment responses to pregabalin : an exploratory post-hoc analysis. In: Journal of Pain Research. 2019 ; Vol. 12. pp. 2577-2587.
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abstract = "Background: Euphoria is a complex, multifactorial problem that is reported as an adverse event in clinical trials of analgesics including pregabalin. The relationship between the reporting of euphoria events and pregabalin early treatment responses was examined in this exploratory post-hoc analysis.Methods: Data were from patients with neuropathic or non-neuropathic chronic pain enrolled in 40 randomized clinical trials, who received pregabalin (75-600 mg/day) or placebo. Reports of treatment-emergent euphoria events were based on the Medical Dictionary of Regulatory Activities preferred term {"}euphoric mood{"}. Prevalence rates of euphoria events overall and by indication were assessed. Post-treatment endpoints included >= 30{\%} improvements in pain and sleep scores up to 3 weeks as well as a >= 1-point improvement in daily pain score up to 11 days after treatment.Results: 13,252 patients were analyzed; 8,501 (64.1{\%}) and 4,751 (35.9{\%}) received pregabalin and placebo, respectively. Overall, 1.7{\%} (n=222) of patients reported euphoria events. Among pregabalin-treated patients, a larger proportion who reported euphoria events achieved an early pain response compared with those who did not report euphoria (30{\%} pain responders in week 1 with euphoria events [43.0{\%}], without euphoria events [24.2{\%}]). Results were similar for weeks 2 and 3. For Days 2-11, a larger proportion of pregabalin-treated patients with (relative to without) euphoria events were 1-point pain responders. Findings were similar in pregabalin-treated patients for sleep endpoints (30{\%} sleep responders in week 1 with euphoria events [50.7{\%}], without euphoria events [36.1{\%}]). Similar results were found for weeks 2 and 3. Patients who received placebo showed similar patterns, although the overall number of them who reported euphoria events was small (n=13).Conclusion: In patients who received pregabalin for neuropathic or non-neuropathic chronic pain, those who experienced euphoria events may have better early treatment responses than those who did not report euphoria events.",
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author = "Bruce Parsons and Rainer Freynhagen and Stephan Schug and Ed Whalen and Marie Ortiz and Brown, {Pritha Bhadra} and Lloyd Knapp",
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The relationship between the reporting of euphoria events and early treatment responses to pregabalin : an exploratory post-hoc analysis. / Parsons, Bruce; Freynhagen, Rainer; Schug, Stephan; Whalen, Ed; Ortiz, Marie; Brown, Pritha Bhadra; Knapp, Lloyd.

In: Journal of Pain Research, Vol. 12, 2019, p. 2577-2587.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The relationship between the reporting of euphoria events and early treatment responses to pregabalin

T2 - an exploratory post-hoc analysis

AU - Parsons, Bruce

AU - Freynhagen, Rainer

AU - Schug, Stephan

AU - Whalen, Ed

AU - Ortiz, Marie

AU - Brown, Pritha Bhadra

AU - Knapp, Lloyd

PY - 2019

Y1 - 2019

N2 - Background: Euphoria is a complex, multifactorial problem that is reported as an adverse event in clinical trials of analgesics including pregabalin. The relationship between the reporting of euphoria events and pregabalin early treatment responses was examined in this exploratory post-hoc analysis.Methods: Data were from patients with neuropathic or non-neuropathic chronic pain enrolled in 40 randomized clinical trials, who received pregabalin (75-600 mg/day) or placebo. Reports of treatment-emergent euphoria events were based on the Medical Dictionary of Regulatory Activities preferred term "euphoric mood". Prevalence rates of euphoria events overall and by indication were assessed. Post-treatment endpoints included >= 30% improvements in pain and sleep scores up to 3 weeks as well as a >= 1-point improvement in daily pain score up to 11 days after treatment.Results: 13,252 patients were analyzed; 8,501 (64.1%) and 4,751 (35.9%) received pregabalin and placebo, respectively. Overall, 1.7% (n=222) of patients reported euphoria events. Among pregabalin-treated patients, a larger proportion who reported euphoria events achieved an early pain response compared with those who did not report euphoria (30% pain responders in week 1 with euphoria events [43.0%], without euphoria events [24.2%]). Results were similar for weeks 2 and 3. For Days 2-11, a larger proportion of pregabalin-treated patients with (relative to without) euphoria events were 1-point pain responders. Findings were similar in pregabalin-treated patients for sleep endpoints (30% sleep responders in week 1 with euphoria events [50.7%], without euphoria events [36.1%]). Similar results were found for weeks 2 and 3. Patients who received placebo showed similar patterns, although the overall number of them who reported euphoria events was small (n=13).Conclusion: In patients who received pregabalin for neuropathic or non-neuropathic chronic pain, those who experienced euphoria events may have better early treatment responses than those who did not report euphoria events.

AB - Background: Euphoria is a complex, multifactorial problem that is reported as an adverse event in clinical trials of analgesics including pregabalin. The relationship between the reporting of euphoria events and pregabalin early treatment responses was examined in this exploratory post-hoc analysis.Methods: Data were from patients with neuropathic or non-neuropathic chronic pain enrolled in 40 randomized clinical trials, who received pregabalin (75-600 mg/day) or placebo. Reports of treatment-emergent euphoria events were based on the Medical Dictionary of Regulatory Activities preferred term "euphoric mood". Prevalence rates of euphoria events overall and by indication were assessed. Post-treatment endpoints included >= 30% improvements in pain and sleep scores up to 3 weeks as well as a >= 1-point improvement in daily pain score up to 11 days after treatment.Results: 13,252 patients were analyzed; 8,501 (64.1%) and 4,751 (35.9%) received pregabalin and placebo, respectively. Overall, 1.7% (n=222) of patients reported euphoria events. Among pregabalin-treated patients, a larger proportion who reported euphoria events achieved an early pain response compared with those who did not report euphoria (30% pain responders in week 1 with euphoria events [43.0%], without euphoria events [24.2%]). Results were similar for weeks 2 and 3. For Days 2-11, a larger proportion of pregabalin-treated patients with (relative to without) euphoria events were 1-point pain responders. Findings were similar in pregabalin-treated patients for sleep endpoints (30% sleep responders in week 1 with euphoria events [50.7%], without euphoria events [36.1%]). Similar results were found for weeks 2 and 3. Patients who received placebo showed similar patterns, although the overall number of them who reported euphoria events was small (n=13).Conclusion: In patients who received pregabalin for neuropathic or non-neuropathic chronic pain, those who experienced euphoria events may have better early treatment responses than those who did not report euphoria events.

KW - euphoria

KW - pain

KW - pregabalin

KW - sleep

KW - DIABETIC PERIPHERAL NEUROPATHY

KW - PLACEBO-CONTROLLED TRIAL

KW - SPINAL-CORD-INJURY

KW - PHASE-III TRIAL

KW - DOUBLE-BLIND

KW - POSTHERPETIC NEURALGIA

KW - CHRONIC PAIN

KW - CLINICAL-TRIALS

KW - SLEEP INTERFERENCE

KW - EFFICACY

U2 - 10.2147/JPR.S199203

DO - 10.2147/JPR.S199203

M3 - Article

VL - 12

SP - 2577

EP - 2587

JO - Journal of Pain Research

JF - Journal of Pain Research

SN - 1178-7090

ER -