Randomized Controlled Trial of Diclofenac Sodium Gel in Knee Osteoarthritis

Barthel, H. Richard; D, Haselwood; Longley, Selden; Gold, Morris S.; Altman, Roy D.

doi:10.1016/j.semarthrit.2009.09.002

Cited by 94 publications

(75 citation statements)

References 37 publications

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“…Efficacy and overall tolerability results have been reported elsewhere. 9 For this analysis, patients were categorized as either receiving or not receiving concurrent medications known to have a DDI with diclofenac. Drugs with the potential for DDIs with diclofenac were identified using Drugs.com.…”

Section: Methodsmentioning

confidence: 99%

“…These included significant pain in the contralateral knee or a history or present evidence of secondary OA, rheumatoid arthritis, fibromyalgia, or other chronic inflammatory disease. 9 In addition, patients were excluded if they had evidence of an active peptic ulcer or history of gastrointestinal bleeding, and if they had a clinically significant medical disease that might compromise their welfare or confound study results. These included a recent history (#12 months [m]) or current signs of severe uncontrolled renal, hepatic, hematological, endocrine, cardiovascular, and neurological disease.…”

Section: Participantsmentioning

confidence: 99%

“…6 In randomized controlled trials, diclofenac sodium 1% gel (DSG; Voltaren ® Gel, Novartis Consumer Health, Parsippany, NJ, USA) demonstrated efficacy similar to that of oral NSAIDs in patients with osteoarthritis of the knees or hands, with an occurrence of systemic AEs similar to placebo. [7][8][9] Subgroup analyses have shown similar efficacy and tolerability in elderly and younger patients and in those with and without an increased risk of cardiovascular and renal AEs. 10,11 Pharmacokinetic evidence indicates that diclofenac sodium 1% gel facilitates the guideline recommendation to use the lowest effective dose of NSAID to achieve effective relief.…”

Section: Introductionmentioning

confidence: 96%

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Tolerability of diclofenac sodium 1% gel with concomitant medications known to interact with diclofenac

Wieman¹,

Peniston²,

Gold³

et al. 2012

The Journal of Pain

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Background: Topical diclofenac sodium 1% gel (DSG) has demonstrated efficacy and tolerability in patients with osteoarthritis (OA) of the knees or hands, including elderly patients and those with an increased risk of gastrointestinal, cardiovascular, and renal adverse events (AEs). Medications known to interact with diclofenac were disallowed in a clinical trial of DSG for knee OA; however, patients were not to be discontinued for intake of disallowed treatment, unless there was a safety issue. This post hoc analysis examined the frequency and type of AEs in patients who received DSG concomitantly with drugs known to have potential interactions with diclofenac. Materials and methods: This was a post hoc analysis of a randomized controlled trial of DSG for knee OA pain. Patients (n = 254) aged $ 35 years with OA in one or both knees, but with clinical OA symptoms in only one knee, administered DSG topically to the target knee four times daily (total dose, 16 g/d) for 12 weeks. Drugs with the potential for major or moderate drug-drug interactions (DDIs) were identified via Drugs.com. AE rates were compared in patients with versus those without $1 potential DDI. Results: At least one AE was experienced by 62.6% (107/171) of patients with $1 DDI and by 55.4% (46/83) of patients with no DDIs. Gastrointestinal AEs (upper and lower) were reported in 5.3% (9/171) and 7.2% (6/83), cardiovascular AEs in 4.7% (8/171) and 1.2% (1/83), renal AEs in 1.2% (2/171) and 0%, and hepatic AEs in 0% and 1.2% (1/83) of patients with $1 DDI compared with patients with no DDIs, respectively. Conclusion: Concurrent use of DSG with medications that had potential for major to moderate DDIs had little impact on the frequency of AEs in this population. Further research is needed to consider how factors such as dose, duration, and timing of concomitant drug administration may affect the likelihood of clinically evident AEs resulting from a potential DDI.

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Section: Methodsmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

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Tolerability of diclofenac sodium 1% gel with concomitant medications known to interact with diclofenac

Wieman¹,

Peniston²,

Gold³

et al. 2012

The Journal of Pain

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“…Barthel и соавт. (2009) [24] дана оценка локального применения диклофенака натрия геля 1%-ного, его эффективности и безопасности в терапии мягких и умеренно-выраженных проявлений ОА колен-ного сустава. В исследование вошли 492 пациента в воз-расте старше 35 лет с проявлениями ОА коленного суста-ва (длительностью более 6 мес.…”

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“…Через 1 неделю в 64% случаев наблюдалась положительная дина-мика по данным результатов оценки Международного общества исследований артроза (Osteoarthritis Research Society International), которая сохранялась в течение всех 12 недель исследования. В течение 3-месячного периода локального применения геля диклофенак 1%-ного полу-чена статистически достоверная клиническая динамика в отношении выраженности болевого синдрома (по ВАШ) и функционального состояния (по WOMAC) у пациентов с ОА коленного сустава [24].…”

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Efficacy of Local Nsaids Therapy With Osteoarthritis Different Localization

Шавловская¹

2017

Med. sov.

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Современные стандарты лечения предпочитают один из самых популярных неселективных НПВП -диклофенак, который по соотношению «эффективность/безопасность» по праву называют «золотым стандартом» анальгетической терапии. В последние годы при лечении болей в суставах широкое применение получил Вольтарен Эмульгель 1% и 2%. В настоя-щее время имеется убедительная доказательная база, свидетельствующая о его анальгетическом и противовоспалитель-ном действии как при травматических повреждениях связок и мышц, сопровождающихся выраженным болевым синдро-мом, так и при хронических воспалительных процессах в суставах у пациентов всех возрастов.Ключевые слова: нестероидные противовоспалительные препараты, диклофенак, Вольтарен Эмульгель, остеоартроз, болевой синдром. O.A. SHAVLOVSKAYA, MD, Sechenov First Moscow State Medical University EFFICACY OF LOCAL NSAIDS THERAPY WITH OSTEOARTHRITIS DIFFERENT LOCALIZATIONModern standards of treatment prefer one of the most popular non-selective NSAIDs -diclofenac, which is the ratio efficiency/ safety is rightly called the «gold standard» analgesic therapy. In recent years in the treatment of joint pain widely used Voltaren Emulgel 1% and 2%. Currently, there is a convincing evidence base testifying to its analgesic and anti-inflammatory action, as in traumatic injuries of the ligaments and muscles, accompanied by severe pain syndrome, and chronic inflammatory processes in the joints, patients of all ages.

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