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Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials

BACKGROUND: Greater understanding of factors associated with the high placebo-response rates noted in recent neuropathic pain trials may improve trial design. This study investigated placebo response and its predictors in pregabalin trials in patients with diabetic peripheral neuropathy (DPN) or pos...

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Autores principales: Freeman, Roy, Emir, Birol, Parsons, Bruce
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4459620/
https://www.ncbi.nlm.nih.gov/pubmed/26082659
http://dx.doi.org/10.2147/JPR.S78303
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author Freeman, Roy
Emir, Birol
Parsons, Bruce
author_facet Freeman, Roy
Emir, Birol
Parsons, Bruce
author_sort Freeman, Roy
collection PubMed
description BACKGROUND: Greater understanding of factors associated with the high placebo-response rates noted in recent neuropathic pain trials may improve trial design. This study investigated placebo response and its predictors in pregabalin trials in patients with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia. PATIENTS AND METHODS: Individual patient data from 16 randomized, placebo-controlled, double-blind trials of pregabalin in 3,053 patients with DPN and 1,460 patients with postherpetic neuralgia were pooled (by condition and all together) in order to investigate the placebo response and its predictors. Univariate and multivariate analyses were performed across all 16 trials to identify predictors of change in pain score in patients. Trials with a >2-point mean reduction in pain score at endpoint with placebo were designated high placebo response and were compared with low placebo-response trials (those with a ≤2-point mean reduction) with respect to patient and study characteristics. RESULTS: Three high placebo-response studies were identified, with all in DPN patients and all conducted postapproval of pregabalin. Younger age, higher mean baseline pain score, longer study duration, higher ratio of patients on active treatment to placebo, and study conducted postapproval were all significantly associated with a higher placebo response (P<0.05). There was a trend towards an increased placebo response in all studies over time without any corresponding change in the response to pregabalin. CONCLUSION: Consideration of the factors identified here as contributing to a higher placebo response could help improve the sensitivity and accuracy of clinical trials in patients with neuropathic pain.
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spelling pubmed-44596202015-06-16 Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials Freeman, Roy Emir, Birol Parsons, Bruce J Pain Res Original Research BACKGROUND: Greater understanding of factors associated with the high placebo-response rates noted in recent neuropathic pain trials may improve trial design. This study investigated placebo response and its predictors in pregabalin trials in patients with diabetic peripheral neuropathy (DPN) or postherpetic neuralgia. PATIENTS AND METHODS: Individual patient data from 16 randomized, placebo-controlled, double-blind trials of pregabalin in 3,053 patients with DPN and 1,460 patients with postherpetic neuralgia were pooled (by condition and all together) in order to investigate the placebo response and its predictors. Univariate and multivariate analyses were performed across all 16 trials to identify predictors of change in pain score in patients. Trials with a >2-point mean reduction in pain score at endpoint with placebo were designated high placebo response and were compared with low placebo-response trials (those with a ≤2-point mean reduction) with respect to patient and study characteristics. RESULTS: Three high placebo-response studies were identified, with all in DPN patients and all conducted postapproval of pregabalin. Younger age, higher mean baseline pain score, longer study duration, higher ratio of patients on active treatment to placebo, and study conducted postapproval were all significantly associated with a higher placebo response (P<0.05). There was a trend towards an increased placebo response in all studies over time without any corresponding change in the response to pregabalin. CONCLUSION: Consideration of the factors identified here as contributing to a higher placebo response could help improve the sensitivity and accuracy of clinical trials in patients with neuropathic pain. Dove Medical Press 2015-06-01 /pmc/articles/PMC4459620/ /pubmed/26082659 http://dx.doi.org/10.2147/JPR.S78303 Text en © 2015 Freeman et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Freeman, Roy
Emir, Birol
Parsons, Bruce
Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
title Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
title_full Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
title_fullStr Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
title_full_unstemmed Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
title_short Predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
title_sort predictors of placebo response in peripheral neuropathic pain: insights from pregabalin clinical trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4459620/
https://www.ncbi.nlm.nih.gov/pubmed/26082659
http://dx.doi.org/10.2147/JPR.S78303
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