Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older

Sanford H Roth1, Philip Fuller21Arizona Research and Education, Phoenix, AZ, 2Medical Affairs, Mallinckrodt Inc, Hazelwood, MOBackground: This study aimed to determine the safety of diclofenac sodium topical solution 1.5% (w/w) in 45.5% dimethyl sulfoxide (TDiclo) for the treatment of knee or hand o...

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Autores principales:	Roth SH, Fuller P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	adverse events analgesic arthritis gastrointestinal NSAID tolerability Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/e8a184d49a6643b98d242f30c48699e0
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spelling	oai:doaj.org-article:e8a184d49a6643b98d242f30c48699e02021-12-02T00:25:39ZPooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older1178-1998https://doaj.org/article/e8a184d49a6643b98d242f30c48699e02012-06-01T00:00:00Zhttps://www.dovepress.com/pooled-safety-analysis-of-diclofenac-sodium-topical-solution-15-ww-in--peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Sanford H Roth1, Philip Fuller21Arizona Research and Education, Phoenix, AZ, 2Medical Affairs, Mallinckrodt Inc, Hazelwood, MOBackground: This study aimed to determine the safety of diclofenac sodium topical solution 1.5% (w/w) in 45.5% dimethyl sulfoxide (TDiclo) for the treatment of knee or hand osteoarthritis in persons aged 75 years or older.Methods: A pooled analysis of safety data from seven multicenter, randomized, blinded, Phase III clinical trials (4–12 weeks' duration) of TDiclo was conducted. The analysis focused on a subset of patients (n = 280) aged 75 years or older with a primary diagnosis of osteoarthritis of the knee (six trials) or hand (one trial). Patients received one of three topical treatments: TDiclo (n = 138); placebo (2.33% or 4.55% dimethyl sulfoxide, n = 39); or control (45.5% dimethyl sulfoxide, n = 103). Treatment groups were compared using Chi-square analysis, Fisher's Exact test, or analysis of variance.Results: The most common adverse events involved the skin or subcutaneous tissue, primarily at the application site. The incidence of dry skin was higher in the TDiclo (36.2%; P < 0.0001) and dimethyl sulfoxide control (18.4%; P = 0.0142) groups than in the placebo group (2.6%); the incidence of other skin or subcutaneous tissue adverse events was similar between the groups. Relatively few patients (<18%) experienced gastrointestinal adverse events, and group differences were not detected. In the TDiclo group, constipation (3.6%), diarrhea (3.6%), and nausea (3.6%) were the most common gastrointestinal adverse events. Cardiovascular and renal/urinary adverse events were rare, and group differences were not detected. There was one case (0.7%) each of hypertension, spider veins, and vasodilation in the TDiclo group. Changes from baseline to the final visit in blood pressure and hepatic/renal enzyme levels were also similar between the groups.Conclusion: TDiclo appears to be well tolerated for the treatment of osteoarthritis in persons aged 75 years or older.Keywords: adverse events, analgesic, arthritis, gastrointestinal, nonsteroidal anti-inflammatory drugs, tolerabilityRoth SHFuller PDove Medical Pressarticleadverse eventsanalgesicarthritisgastrointestinalNSAIDtolerabilityGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 7, Pp 127-137 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	adverse events analgesic arthritis gastrointestinal NSAID tolerability Geriatrics RC952-954.6
spellingShingle	adverse events analgesic arthritis gastrointestinal NSAID tolerability Geriatrics RC952-954.6 Roth SH Fuller P Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
description	Sanford H Roth1, Philip Fuller21Arizona Research and Education, Phoenix, AZ, 2Medical Affairs, Mallinckrodt Inc, Hazelwood, MOBackground: This study aimed to determine the safety of diclofenac sodium topical solution 1.5% (w/w) in 45.5% dimethyl sulfoxide (TDiclo) for the treatment of knee or hand osteoarthritis in persons aged 75 years or older.Methods: A pooled analysis of safety data from seven multicenter, randomized, blinded, Phase III clinical trials (4–12 weeks' duration) of TDiclo was conducted. The analysis focused on a subset of patients (n = 280) aged 75 years or older with a primary diagnosis of osteoarthritis of the knee (six trials) or hand (one trial). Patients received one of three topical treatments: TDiclo (n = 138); placebo (2.33% or 4.55% dimethyl sulfoxide, n = 39); or control (45.5% dimethyl sulfoxide, n = 103). Treatment groups were compared using Chi-square analysis, Fisher's Exact test, or analysis of variance.Results: The most common adverse events involved the skin or subcutaneous tissue, primarily at the application site. The incidence of dry skin was higher in the TDiclo (36.2%; P < 0.0001) and dimethyl sulfoxide control (18.4%; P = 0.0142) groups than in the placebo group (2.6%); the incidence of other skin or subcutaneous tissue adverse events was similar between the groups. Relatively few patients (<18%) experienced gastrointestinal adverse events, and group differences were not detected. In the TDiclo group, constipation (3.6%), diarrhea (3.6%), and nausea (3.6%) were the most common gastrointestinal adverse events. Cardiovascular and renal/urinary adverse events were rare, and group differences were not detected. There was one case (0.7%) each of hypertension, spider veins, and vasodilation in the TDiclo group. Changes from baseline to the final visit in blood pressure and hepatic/renal enzyme levels were also similar between the groups.Conclusion: TDiclo appears to be well tolerated for the treatment of osteoarthritis in persons aged 75 years or older.Keywords: adverse events, analgesic, arthritis, gastrointestinal, nonsteroidal anti-inflammatory drugs, tolerability
format	article
author	Roth SH Fuller P
author_facet	Roth SH Fuller P
author_sort	Roth SH
title	Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
title_short	Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
title_full	Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
title_fullStr	Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
title_full_unstemmed	Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
title_sort	pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/e8a184d49a6643b98d242f30c48699e0
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Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older

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