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A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain

Pregabalin is a commonly used therapy currently recommended as first-line treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can...

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Autores principales: Freynhagen, Rainer, Serpell, Michael, Emir, Birol, Whalen, Ed, Parsons, Bruce, Clair, Andrew, Latymer, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4320770/
https://www.ncbi.nlm.nih.gov/pubmed/24279736
http://dx.doi.org/10.1111/papr.12146
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author Freynhagen, Rainer
Serpell, Michael
Emir, Birol
Whalen, Ed
Parsons, Bruce
Clair, Andrew
Latymer, Mark
author_facet Freynhagen, Rainer
Serpell, Michael
Emir, Birol
Whalen, Ed
Parsons, Bruce
Clair, Andrew
Latymer, Mark
author_sort Freynhagen, Rainer
collection PubMed
description Pregabalin is a commonly used therapy currently recommended as first-line treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient-level data from 31 randomized clinical trials of pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (AEs). Incidence by age, disease condition, and race, together with risk differences and time to onset and resolution of AEs, was assessed. In total, 7,510 patients were included: 4,884 on pregabalin (representing 805 patient-years treatment) and 2,626 on placebo. Pregabalin vs. placebo risk analysis identified 9 AEs with a risk difference, for which the lower limit of the 95% confidence interval (CI) was > 1%: dizziness (risk difference [95% CI]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common AEs, dizziness and somnolence, typically emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in cessation of treatment. The data from this review provide information, indicating which AEs may be expected in patients treated with pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.
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spelling pubmed-43207702015-02-13 A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain Freynhagen, Rainer Serpell, Michael Emir, Birol Whalen, Ed Parsons, Bruce Clair, Andrew Latymer, Mark Pain Pract Original Articles Pregabalin is a commonly used therapy currently recommended as first-line treatment for a number of neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient-level data from 31 randomized clinical trials of pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (AEs). Incidence by age, disease condition, and race, together with risk differences and time to onset and resolution of AEs, was assessed. In total, 7,510 patients were included: 4,884 on pregabalin (representing 805 patient-years treatment) and 2,626 on placebo. Pregabalin vs. placebo risk analysis identified 9 AEs with a risk difference, for which the lower limit of the 95% confidence interval (CI) was > 1%: dizziness (risk difference [95% CI]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common AEs, dizziness and somnolence, typically emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in cessation of treatment. The data from this review provide information, indicating which AEs may be expected in patients treated with pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice. Blackwell Publishing Ltd 2015-01 2013-11-27 /pmc/articles/PMC4320770/ /pubmed/24279736 http://dx.doi.org/10.1111/papr.12146 Text en © 2013 Pfizer Inc. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Freynhagen, Rainer
Serpell, Michael
Emir, Birol
Whalen, Ed
Parsons, Bruce
Clair, Andrew
Latymer, Mark
A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
title A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
title_full A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
title_fullStr A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
title_full_unstemmed A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
title_short A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
title_sort comprehensive drug safety evaluation of pregabalin in peripheral neuropathic pain
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4320770/
https://www.ncbi.nlm.nih.gov/pubmed/24279736
http://dx.doi.org/10.1111/papr.12146
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