LATE-BREAKING ABSTRACT: Effect of fluticasone furoate (FF)/vilanterol (VI) on the rate of COPD exacerbations in everyday clinical practice: Results of the COPD Salford lung study (SLS)
EUROPEAN RESPIRATORY JOURNAL(2016)
摘要
SLS is an open label RCT that aims to guide COPD treatment by generating effectiveness and safety data in a population intended to represent that seen in everyday clinical practice (Bakerly et al. Respir Res 2015;16:101). COPD patients u003e40 years with ≥1 exacerbation in the previous 3 years were randomized 1:1 to initiate treatment with FF/VI 100/25mcg OD or continue on usual maintenance therapy (UC) for 12 months. Safety monitoring was performed by telephone every 3 months (unless other contact); other data were collected in real-time using an integrated primary u0026 secondary care electronic medical record to normalise the patient experience. Primary endpoint is annual rate of moderate/severe exacerbations. Based on 2799 ITT patients; baseline exacerbation rate was 2.01; pre-bronchodilator FEV 1 % predicted was 56%. 177 patients experienced an SAE of pneumonia 94 initiated on FF/VI; 83 on UC (Incidence ratio 1.1, 95% CI 0.9–1.5). The SAE profile was similar across the groups. In an everyday clinical practice setting treatment initiated with FF/VI significantly reduced the rate of exacerbations compared with UC. FF/VI was non-inferior to UC for incidence of pneumonia. GSK Funded (HZC115151; NCT01551758).
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关键词
COPD - management,Exacerbation,Primary care
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