SPINE
A randomized, clinical trial to assess the relative efficacy and tolerability of two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(10):4 BMC Musculoskelet Disord. 2016 Oct 13;17(1):4261015 patients with ankylosing spondylitis were randomized initially to 6 weeks of either etoricoxib 60mg daily, etoricoxib 90mg daily, or naproxen 1000mg daily. After 6 weeks, patients of the etoricoxib 60mg group were re-randomized to either continue on etoricoxib 60mg daily for 20 weeks or increase to etoricoxib 90mg daily for 20 weeks. Within the first 6 weeks, both etoricoxib 60mg and etoricoxib 90mg demonstrated noninferior efficacy in reducing spinal pain when compared to naproxen 1000mg. At 26 weeks, a similar degree of reduction in spinal pain was observed among all groups. Etoricoxib did not appear to increase the risk of treatment-related adverse events compared to naproxen.
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。
1/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
2/4
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？
Ankylosing spondylitis is a chronic condition characterized by inflammation of the spine and joints, often causing debilitating pain. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) has been standard in first-line management for patients with ankylosing spondylitis. Naproxen, a nonselective NSAID, is a common drug used for the management of ankylosing spondylitis, despite reports of increased gastrointestinal adverse events associated with the use of nonselective NSAIDs. Selective COX-2 inhibitors, such as etoricoxib, have been introduced as alternatives to nonselective NSAIDs for a number of indications, though more data from randomized controlled trials was needed to evaluate the efficacy of etoricoxib in ankylosing spondylitis treatment.
主な研究課題は何ですか？
In patients with ankylosing spondylitis, is the treatment efficacy and safety with either etoricoxib 60mg or etoricoxib 90mg noninferior to naproxen 1000mg when assessed over 6 weeks?
重要な知見は？
- The upper bound of 95% confidence intervals for the difference in mean change in Spinal Pain Intensity from baseline to 6 weeks between etoricoxib 60mg and naproxen 1000mg (1.59 [95%CI -2.19, 5.37]) and between etoricoxib 90mg and naproxen 1000mg (-0.64 [95%CI -5.47, 4.19]) did not exceed the prespecified noninferiority margin of 8mm, suggesting noninferiority of both etoricoxib doses.
- Of patients who initially received etoricoxib 60mg in part 1 of the study and demonstrated inadequate response after 6 weeks (<50% improvement from baseline Spinal Pain Intensity), the change in Spinal Pain Intensity from 6 weeks to 10 and 12 weeks was significantly greater in those who switched to etoricoxib 90mg compared to those who remained on etoricoxib 60mg (MD -2.70 [95%CI -4.88, -0.52]), though this did not meet the threshold of clinical significance (6mm).
- Mean reduction in Spinal Pain Intensity from baseline to 26 weeks was similar between the etoricoxib 60mg/etoricoxib 60mg group (-35.07 [95%CI -37.41, -32.73]), the etoricoxib 60mg/etoricoxib 90mg group (-36.30 [95%CI -38.65, -33.96]), the etoricoxib 90/etoricoxib 90mg group (-36.76 [95%CI -40.22, -33.31]), and the naproxen 1000mg group (-38.26 [95%CI -41.70, -34.83]).
- Within part 1, the percentage of patients who discontinued due to lack of efficacy did not significantly differ between either the etoricoxib 60mg group (20/694; 2.88%) or the etoricoxib 90mg group (2/154; 1.30%) compared to the naproxen 1000mg group (2/154; 1.30%).
- Within part 1, the percentage of patients with an adverse event related to treatment was 12.1% in the etoricoxib 60mg group (85/702), 7.1% in the etoricoxib 90mg group (11/155), and 13.5% in the naproxen 1000mg group (21/156). Within part 2, percentage of patients with an adverse event related to treatment was 6.4% in the etoricoxib 60mg/etoricoxib60mg group (20/313), 6.3% in the etoricoxib 60mg/etoricoxib 90mg group (20/319), 4.8% in the etoricoxib 90mg/etoricoxib 90mg group (7/145), and 8.5% in the naproxen 1000mg group (12/142).
最も覚えておくべきことは？
In the treatment of ankylosing spondylitis, both etoricoxib 60mg and etoricoxib 90mg doses demonstrated noninferior 6-week efficacy in managing symptomatic pain when compared to naproxen 1000mg. Similar overall pain reduction after 26 weeks was also noted between groups, regardless of if the dose of etoricoxib was increased after 6 weeks. Additionally, there did not appear to be an increase in treatment-related adverse events associated with etoricoxib compared to naproxen.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that etoricoxib, administered as either daily 60mg or 90mg doses, may offer an effective and safe alternative to naproxen 1000mg for the management of patients with ankylosing spondylitis. As acknowledged by the authors, the current study did not assess the radiographic status of disease during the course of treatment, suggesting that future studies could consider radiographic outcomes as part of follow-up.
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