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)?
Oui = 1
Incertain = 0,5
Non pertinent = 0
Non = 0
L'évaluation des critères de rapport permet d'évaluer la transparence avec laquelle les auteurs rapportent les caractéristiques méthodologiques et les caractéristiques de l'essai dans la publication. L'évaluation est divisée en cinq catégories qui sont présentées ci-dessous.
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
L'indice de fragilité est un outil qui aide à l'interprétation des résultats significatifs, en fournissant une mesure de la force d'un résultat. L'indice de fragilité représente le nombre d'événements consécutifs qui doivent être ajoutés à un résultat dichotomique pour que le résultat ne soit plus significatif. Un petit nombre représente un résultat plus faible et un grand nombre un résultat plus fort.
Pourquoi cette étude était-elle nécessaire maintenant ?
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.
Quelle était la principale question de recherche ?
Does 6 week treatment of Lumiracoxib 400 mg od provide a better GI safety profile when compared to Rofecoxib 25 mg od?
Quels sont les résultats importants ?
- 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.
De quoi dois-je me souvenir en priorité ?
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.
Comment cela affectera-t-il les soins prodigués à mes patients ?
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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