Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

No clasificado

Efficacy and tolerability of celecoxib and naproxen versus placebo in Hispanic patients with knee osteoarthritis.

Revista International journal of general medicine
Año 2014
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 14 Revisiones sistemáticas Revisiones sistemáticas (14 referencias)

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BACKGROUND: Celecoxib is an effective treatment for osteoarthritis (OA). However, information on its efficacy and safety profile in different racial/ethnic groups is limited. Noticeable differences among racial groups are found in other disease states, but a thorough investigation of OA is lacking. The objective of this study was to determine if celecoxib 200 mg once daily is as effective as naproxen 500 mg twice daily in the treatment of OA of the knee in Hispanic patients. METHODS: Hispanic patients aged ≥45 years with knee OA were randomized to receive celecoxib 200 mg once daily, naproxen 500 mg twice daily, or placebo for 6 weeks. The primary efficacy variable was the change in Patient's Assessment of Arthritis Pain at 6 weeks compared with baseline. Secondary variables were change in Patient's and Physician's Global Assessments of Arthritis from baseline to week 6/early termination, change in Western Ontario and McMaster Universities OA Index (WOMAC) from baseline to week 6/early termination, change in American Pain Society pain score, Pain Satisfaction Scale, Patient Health Questionnaire (PHQ-9), and measurements of upper gastrointestinal tolerability. RESULTS: In total, 239 patients completed the trial (96 celecoxib, 96 naproxen, 47 placebo). Celecoxib was as effective as naproxen in reducing OA pain (least squares mean change from baseline [standard error] -39.7 [2.7] for celecoxib and -36.9 [2.6] for naproxen). Patient's and Physician's Global Assessments of Arthritis, WOMAC scores, upper gastrointestinal tolerability, Pain Satisfaction Scale, and PHQ-9 showed no statistically significant differences between the celecoxib and naproxen groups. The incidence of adverse events and treatment-related adverse events were similar among the treatment groups. CONCLUSION: Celecoxib 200 mg once daily was as effective as naproxen 500 mg twice daily in the treatment of signs and symptoms of knee OA in Hispanic patients. Celecoxib was shown to be safe and well tolerated in this patient population.

Estudio primario

No clasificado

Etoricoxib in the treatment of Korean patients with osteoarthritis in a double-blind, randomized controlled trial.

Revista Current medical research and opinion
Año 2014
Enlaces Pubmed DOI

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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<b>OBJECTIVE: </b>We evaluated the COX-2 inhibitors, etoricoxib and celecoxib, in Korean patients with osteoarthritis (OA).<b>METHODS: </b>This study included patients (≥ 40 years of age) with a clinical and radiographic diagnosis of knee OA. Patients were randomized to etoricoxib 30 mg (qd) or celecoxib 200 mg (qd) in a 12 week randomized, controlled, double-blind study. Prior NSAID users were to demonstrate a worsening of symptoms upon withdrawal of medication. Efficacy endpoints included the time-weighted average change from baseline in the WOMAC VA 3.0 Pain Subscale (100 mm Visual Analog Scale [VAS]; primary endpoint), the WOMAC VA 3.0 Physical Function Subscale (100 mm VAS), and Patient Global Assessment of Disease Status (PGAD) (100 mm VAS). The primary hypothesis was that etoricoxib 30 mg is non-inferior to celecoxib 200 mg as assessed by the primary endpoint (the non-inferiority margin was set at 10 mm VAS). Adverse events (AEs), laboratory parameters, and vital signs were monitored.<b>RESULTS: </b>There were 239 patients (89.5% female; mean age: 63.3 years) randomized to etoricoxib 30 mg (n = 120) and celecoxib 200 mg (n = 119). The differences (etoricoxib vs celecoxib) in least square (LS) mean change (95% CI) for WOMAC Pain, WOMAC Physical Function, and PGAD were -1.63 mm (-5.37, 2.10), -1.32 mm (-4.88, 2.23), and -1.09 mm (-5.48, 3.30), respectively. Drug-related clinical AEs occurred in 6.7% (etoricoxib) and 2.5% (celecoxib) of patients. This study was limited because it was not designed or powered to adequately capture and evaluate rare AEs associated with NSAID treatment.<b>CONCLUSIONS: </b>Etoricoxib 30 mg administered once daily in Korean patients with knee OA demonstrated non-inferior clinical efficacy to celecoxib 200 mg over 12 weeks of treatment as assessed by all primary and secondary outcomes. Etoricoxib 30 mg qd and celecoxib 200 mg qd were generally safe and well tolerated.<b>Clinical Trial Registration: </b>NCT01554163.

Estudio primario

No clasificado

Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study.

Revista Current medical research and opinion
Año 2014
Enlaces Pubmed DOI

Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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Abstract OBJECTIVE: NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology * ), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three times daily (tid) and twice daily (bid) in patients with OA pain. RESEARCH DESIGN AND METHODS: This double-blind study enrolled patients &gt;=40 years of age with clinically and radiographically confirmed (Kellgren-Lawrence grade II-III) hip or knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale scores &gt;=40 mm by visual analog scale and an OA flare (&gt;=15 mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening). Patients were randomized to submicron diclofenac 35 mg tid, submicron diclofenac 35 mg bid, or placebo for 12 weeks. ClinicalTrials.gov identifier: NCT01461369. MAIN OUTCOME MEASURES: Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week 12 (primary efficacy parameter) and in average total WOMAC score over 12 weeks. RESULTS: Submicron diclofenac 35 mg tid significantly improved WOMAC pain subscale scores from baseline at 12 weeks (-44.1; p = 0.0024) compared with placebo (-32.5). Submicron diclofenac 35 mg bid provided numerical improvement in pain at week 12 that did not reach statistical significance (-39.0; p = 0.0795) compared with placebo. Submicron diclofenac 35 mg tid (-35.9; p = 0.0002) and 35 mg bid (-30.3; p = 0.0363) improved the average total WOMAC score in treated patients over 12 weeks compared with placebo (-23.2). The most frequent AEs in the submicron diclofenac-treated groups were diarrhea, headache, nausea, and constipation. The inclusion of patients with a documented requirement for analgesic therapy (OA 'flare') at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups. CONCLUSIONS: Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain.

Hilo de publicación

CR002488

Este hilo de publicación incluye 2 referencias

Estudio primario

No clasificado

A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with ...

Revista Rheumatology (Oxford, England)
Año 2013
Enlaces Pubmed DOI

Este artículo está incluido en 22 Revisiones sistemáticas Revisiones sistemáticas (22 referencias)

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Objective. To assess the efficacy and safety of 12-week treatment with ketoprofen in ultradeformable phospholipid vesicles in patients with OA knee pain and to compare the efficacy with that of ketoprofen-free vehicle and celecoxib.Methods. A multicentre, double-blind controlled study in which patients with knee OA and moderate pain were randomized to one of the six arms: topical ketoprofen 50 or 100 mg in ultradeformable vesicles (IDEA-033), 2.2 or 4.4 g ketoprofen-free vehicle (TDT 064), oral celecoxib 100 mg or matching oral placebo, all bd. The primary outcome was change from baseline in the WOMAC pain subscale at week 12.Results. A total of 1395 patients received treatment. Baseline mean WOMAC pain scores ranged from 4.7 to 4.8 across groups. The mean reduction in WOMAC pain score at week 12 was −1.9 (−40.8%) for ketoprofen 50 mg, −1.9 (−40.9%) for ketoprofen 100 mg, −1.9 (−39.8%) for 2.2 g TDT 064, −1.8 (−37.8%) for 4.4 g TDT 064, −1.9 (−40.4%) for celecoxib and −1.4 (−29.3%) for oral placebo. IDEA-033 was not statistically superior to TDT 064. All topical treatments were statistically superior to oral placebo and non-inferior to celecoxib. The most frequent types of treatment-related adverse events reported were gastrointestinal for oral (15.9% for celecoxib) and dermal for topical applications (12.2% for ketoprofen 100 mg).Conclusion. IDEA-033 was not superior to ketoprofen-free vehicle, but both formulations were superior to oral placebo and non-inferior to celecoxib in reducing OA knee pain.Trial registration: ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00716547.

Estudio primario

No clasificado

Response to nonsteroidal anti-inflammatory drugs in African Americans with osteoarthritis of the knee.

Revista The Journal of international medical research
Año 2012
Enlaces Pubmed DOI

Este artículo está incluido en 15 Revisiones sistemáticas Revisiones sistemáticas (15 referencias)

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OBJECTIVE: This 6-week, randomized, double-blind, parallel-group study compared the analgesic efficacy, tolerability and safety of celecoxib, naproxen and placebo in African Americans with osteoarthritis (OA) of the knee. METHODS: A total of 322 patients aged ≥ 45 years with OA of the knee in a flare state received 200 mg celecoxib orally once daily, 500 mg naproxen orally twice daily or placebo for 6 weeks. The primary endpoint was change from baseline in the Patient's Assessment of Arthritis Pain. RESULTS: Celecoxib was as effective as naproxen in reducing OA pain. Similar efficacy was observed in many of the secondary outcome measures. Celecoxib was well tolerated and demonstrated favorable upper gastro-intestinal tolerability. Improvements in outcome measures were numerically greater in the active treatment groups compared with the placebo group, but did not reach statistical significance. CONCLUSIONS: Celecoxib was as effective as naproxen in relieving OA pain in African Americans and was well tolerated. Few significant differences were observed between active treatments and placebo, possibly because of a strong placebo effect.

Estudio primario

No clasificado

La eficacia y la tolerabilidad de celecoxib frente a naproxeno en pacientes con osteoartritis de la rodilla: un, doble ciego, doble simulación aleatorio.

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Autores Essex MN , Bhadra P , Sands GH
Revista The Journal of international medical research
Año 2012
Enlaces Pubmed DOI

Este artículo está incluido en 13 Revisiones sistemáticas Revisiones sistemáticas (13 referencias)

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OBJETIVO: Evaluar la eficacia y la tolerabilidad de celecoxib frente a naproxeno en pacientes con osteoartritis (OA) de rodilla. MÉTODOS: 6 meses, aleatorizado, doble ciego, doble simulación se llevó a cabo en 47 centros en los EE.UU.. Los pacientes con artrosis de rodilla fueron asignados al azar para recibir 200 mg de celecoxib oral una vez al día o 500 mg de naproxeno por vía oral dos veces al día. La variable principal se definió como una mejora del 20% desde el inicio hasta 6 meses en Western Ontario y McMaster Universidades puntuación total (WOMAC) OA. RESULTADOS: Un total de 586 de cada 589 pacientes asignados al azar recibieron al menos una dosis de celecoxib (n = 294) o el naproxeno (n = 292). El criterio principal de valoración (tasa de respuesta de 6 meses) se logró un 52,7% y el 49,7% de los pacientes en los grupos de tratamiento con celecoxib y naproxeno, respectivamente. Significativamente menos interrupciones debido a eventos adversos gastrointestinales ocurrieron en pacientes que recibieron celecoxib que en los que recibieron naproxeno (4,1% frente a 15,1%, respectivamente). Conclusiones: Durante el período de estudio 6 meses, celecoxib proporcionado mejoras similares en los síntomas de OA a naproxeno. Además, celecoxib proporciona una mejor tolerabilidad gastrointestinal superior que el naproxeno.

Estudio primario

No clasificado

A 6-week, multinational, multicenter, randomized, double-blind, double-dummy, parallel-group trial of lumiracoxib 200mg od in patients with primary knee OA, using celecoxib 200mg od as a comparator.(CCOX189A2364)

Autores Novartis
Registro de estudios novctrd.com
Año 2012
Enlaces novctrd.com

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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