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)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
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.
主な研究課題は何ですか？
Does 6 week treatment of Lumiracoxib 400 mg od provide a better GI safety profile when compared to Rofecoxib 25 mg od?
重要な知見は？
- 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.
最も覚えておくべきことは？
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.
それが私の患者ケアにどのように影響するか？
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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