Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities

John H Peniston,1 Morris S Gold,2 Matthew S Wieman,3 Lawrence K Alwine41Feasterville Family Health Care Center, Feasterville, PA, 2Clinical Research and Biostatistics, Novartis Consumer Health Inc, Parsippany, NJ, 3Medical Affairs, Endo Pharmaceuticals Inc, Chadds Ford, PA, 4Downingtown Family Medic...

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Autores principales:	Peniston JH, Gold MS, Wieman MS, Alwine LK
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	diclofenac nonsteroidal anti-inflammatory drugs osteoarthritis topical analgesics Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/ce0134dd7e7e46e2957872a7f2f540b3
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spelling	oai:doaj.org-article:ce0134dd7e7e46e2957872a7f2f540b32021-12-02T03:28:28ZLong-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities1178-1998https://doaj.org/article/ce0134dd7e7e46e2957872a7f2f540b32012-11-01T00:00:00Zhttps://www.dovepress.com/long-term-tolerability-of-topical-diclofenac-sodium-1-gel-for-osteoart-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998John H Peniston,1 Morris S Gold,2 Matthew S Wieman,3 Lawrence K Alwine41Feasterville Family Health Care Center, Feasterville, PA, 2Clinical Research and Biostatistics, Novartis Consumer Health Inc, Parsippany, NJ, 3Medical Affairs, Endo Pharmaceuticals Inc, Chadds Ford, PA, 4Downingtown Family Medicine, Downingtown, PA, USABackground: Adverse events associated with nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat knee and hand osteoarthritis may be more frequent in certain patient populations. Topical NSAIDs, such as diclofenac sodium 1% gel (DSG), have equivalent efficacy and fewer adverse events compared with oral NSAIDs. This post hoc analysis assessed the long-term tolerability of DSG in elderly patients and patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events.Methods: Patients ≥ 35 years of age with knee osteoarthritis applied DSG (4 g) to one or both knees for 12 weeks during either of two primary studies and for 9 months during a long-term extension study. Other patients entered the long-term extension study directly and applied DSG for 12 months. Safety was assessed by reported adverse events. Subpopulations were defined based on age, or the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.Results: The safety population consisted of 947 patients who received at least one dose of DSG during the primary or extension study. Patients aged < 65 years (68.2%) and ≥65 years (67.2%) experienced any adverse event at similar rates. The percentage of patients who experienced any adverse event was similar between patients with and without hypertension (65.5% versus 69.7%, respectively), type 2 diabetes mellitus (64.0% versus 68.2%), or cerebrovascular or cardiovascular disease (61.9% versus 68.5%). Among the 15 patients with all three comorbidities, the percentage of patients with any adverse event (53.3%) was less than that of patients who did not have all three comorbidities (68.0%).Conclusion: These results suggest that long-term DSG treatment is safe in patient subpopulations with an elevated risk of NSAID-related adverse events, such as the elderly and those with the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.Keywords: diclofenac, nonsteroidal anti-inflammatory drugs, osteoarthritis, topical analgesicPeniston JHGold MSWieman MSAlwine LKDove Medical Pressarticlediclofenacnonsteroidal anti-inflammatory drugsosteoarthritistopical analgesicsGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 7, Pp 517-523 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	diclofenac nonsteroidal anti-inflammatory drugs osteoarthritis topical analgesics Geriatrics RC952-954.6
spellingShingle	diclofenac nonsteroidal anti-inflammatory drugs osteoarthritis topical analgesics Geriatrics RC952-954.6 Peniston JH Gold MS Wieman MS Alwine LK Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
description	John H Peniston,1 Morris S Gold,2 Matthew S Wieman,3 Lawrence K Alwine41Feasterville Family Health Care Center, Feasterville, PA, 2Clinical Research and Biostatistics, Novartis Consumer Health Inc, Parsippany, NJ, 3Medical Affairs, Endo Pharmaceuticals Inc, Chadds Ford, PA, 4Downingtown Family Medicine, Downingtown, PA, USABackground: Adverse events associated with nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat knee and hand osteoarthritis may be more frequent in certain patient populations. Topical NSAIDs, such as diclofenac sodium 1% gel (DSG), have equivalent efficacy and fewer adverse events compared with oral NSAIDs. This post hoc analysis assessed the long-term tolerability of DSG in elderly patients and patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events.Methods: Patients ≥ 35 years of age with knee osteoarthritis applied DSG (4 g) to one or both knees for 12 weeks during either of two primary studies and for 9 months during a long-term extension study. Other patients entered the long-term extension study directly and applied DSG for 12 months. Safety was assessed by reported adverse events. Subpopulations were defined based on age, or the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.Results: The safety population consisted of 947 patients who received at least one dose of DSG during the primary or extension study. Patients aged < 65 years (68.2%) and ≥65 years (67.2%) experienced any adverse event at similar rates. The percentage of patients who experienced any adverse event was similar between patients with and without hypertension (65.5% versus 69.7%, respectively), type 2 diabetes mellitus (64.0% versus 68.2%), or cerebrovascular or cardiovascular disease (61.9% versus 68.5%). Among the 15 patients with all three comorbidities, the percentage of patients with any adverse event (53.3%) was less than that of patients who did not have all three comorbidities (68.0%).Conclusion: These results suggest that long-term DSG treatment is safe in patient subpopulations with an elevated risk of NSAID-related adverse events, such as the elderly and those with the comorbidities of hypertension, type 2 diabetes mellitus, and cerebrovascular or cardiovascular disease.Keywords: diclofenac, nonsteroidal anti-inflammatory drugs, osteoarthritis, topical analgesic
format	article
author	Peniston JH Gold MS Wieman MS Alwine LK
author_facet	Peniston JH Gold MS Wieman MS Alwine LK
author_sort	Peniston JH
title	Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
title_short	Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
title_full	Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
title_fullStr	Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
title_full_unstemmed	Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
title_sort	long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/ce0134dd7e7e46e2957872a7f2f540b3
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Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities

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