FDAから気管支喘息のLABAs(長時間作用型β刺激薬)に関するメタ分析が出ています。情報はDynamedより発信されていました。早いです。PDFは460ページあります。ご注意ください。
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Long-Acting Beta-Agonists and Adverse Asthma Events Meta-Analysis
Statistical Briefing Package for
Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety andRisk Management Advisory Committee and Pediatric Advisory Committee on
December 10-11, 2008
http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-01-FDA.pdf
http://www.fda.gov/default.htm
■気管支喘息患者に
■LABAsを使用すると
■プラセボ・短時間作用型β刺激薬・吸入ステロイド等と比較して
■喘息関連入院・挿管・死亡の複合アウトカムは減るか
■治療、メタ分析
■結果
複合アウトカム
LABAs群 1.26%
比較群 0.99%
(p < 0.05, NNH 357)
喘息による死亡
LABAs群 0.05%
比較群 0.01%
(p < 0.05, NNH 2,500)
Based on the findings from this meta-analysis, LABAs as a group were associated withan increased risk of an asthma composite endpoint consisting of asthma-relatedhospitalization, asthma-related intubation, and asthma-related death among asthmaticsubjects. This overall finding for the asthma composite endpoint was supported both byasthma-related hospitalization and the asthma-related death components. However,findings for individual drugs and subgroups were driven by the asthma-relatedhospitalization component.
The increased risk was seen in three of the four drugs studied, Foradil, Serevent, andSymbicort, but was not apparent in Advair. The increased risk was not apparent when theLABA was used in conjunction with an ICS.
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LABAsを使用すると、2500人に1人殺してしまうという結果です。使用しないほうがよさそうです。
Sereventはセレベント(グラクソSK)。Symbicort(アストラゼネカ、国内未承認)はステロイドとの合剤です。