OSTEOARTHRITIS
A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(3):38 BMC Musculoskelet Disord. 2008 Sep 8;9:118.309 patients, greater than or equal to 50 years, with primary osteoarthritis (OA) were randomized to orally take Lumiracoxib or Rofecoxib for 6 weeks to compare the safety of both modes of treatment. At 6 weeks, the Lumiracoxib was noted to provide a comparable GI safety profile to Rofecoxib in patients with OA.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Sí = 1
Incierto = 0,5
No relevante = 0
No = 0
La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.
2/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
5/5
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.
¿Por qué se necesitaba ahora este estudio?
Osteoarthritis is a common condition that affects 18% women and 10% men above 60 years of age worldwide. Lumiracoxib is effective in treating acute pain conditions such as post-operative dental pain, acute gout, and in treating chronic pain associated with OA. This study investigated whether Lumiracoxib 400mg od can have an effect on GI tolerability.
¿Cuál era la pregunta principal de la investigación?
Does 6 week treatment of Lumiracoxib 400 mg od provide a better GI safety profile when compared to Rofecoxib 25 mg od?
¿Cuáles fueron los hallazgos importantes?
- GI safety profiles: Lumiracoxib treatment group with 43.5% incidence of GI AEs were comparable to 37.4% with Rofecoxib treatment (p>0.05)
- No clinically significant differences were observed between two treatments in terms of GI safety profiles and tolerability.
- Incidence of peripheral oedema was low (n=9; 5.8%) and similar with both treatments.
- At Week 6, the msSBP and msDBP in the lumiracoxib group was significantly lower than the rofecoxib group (p<0.05).
- Both treatments were equally effective in improving target joint pain and diseased activity.
- Lumiracoxib treatment was associated with a significantly better BP profile as compared to rofecoxib treatment.
¿Qué es lo que más debo recordar?
Although, the Lumiracoxib demonstrated similar clinical efficacy in improving target joint pain and disease activity with a similar GI adverse events and peripheral edema compared to Rofecoxib, lumiracoxib has been withdrawn from various markets starting 2007 along with the comparator in the trial, due to their adverse effects.
¿Cómo afectará esto al cuidado de mis pacientes?
Lumiracoxib with recent studies has been proven to not be a safe treatment, despite the findings of this study. More research is required to find safer treatments of OA are needed.
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