Jones Rupert, Martin Jessica, Thomas Vicky, Skinner Derek, Marshall Jonathan, Stagno d'Alcontres Martina, Price David
Clinical Trials and Health Research, Institute of Translational and Stratified Medicine, Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, UK.
Observational and Pragmatic Research Institute, Singapore.
Int J Chron Obstruct Pulmon Dis. 2017 Aug 17;12:2445-2454. doi: 10.2147/COPD.S141409. eCollection 2017.
Chronic obstructive pulmonary disease (COPD), a complex progressive disease, is currently the third leading cause of death worldwide. One recommended treatment option is fixed-dose combination therapy of an inhaled corticosteroid (ICS)/long-acting β-agonist. Clinical trials suggest pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) show similar efficacy and safety profiles in COPD. Real-world observational studies have shown that combination therapy has significantly greater odds of achieving asthma control when delivered via pMDIs. Our aim was to compare effectiveness, in terms of moderate/severe COPD exacerbations and long-acting muscarinic antagonist (LAMA) prescriptions, for COPD patients initiating fluticasone propionate (FP)/salmeterol xinafoate (SAL) via pMDI versus DPI at two doses of FP (500 and 1,000 μg/d) using a real-life, historical matched cohort study. COPD patients with ≥2 years continuous practice data, ≥2 prescriptions for FP/SAL via pMDI/DPI, and no prescription for ICS were selected from the Optimum Patient Care Research Database. Patients were matched 1:1. Rate of moderate/severe COPD exacerbations and odds of LAMA prescription were analyzed using conditional Poisson and logistic regression, respectively. Of 472 patients on 500 μg/d, we observed fewer moderate/severe exacerbations in patients using pMDI (99 [42%]) versus DPI (115 [49%]) (adjusted rate ratio: 0.71; 95% confidence interval: 0.54, 0.93), an important result since the pMDI is not licensed for COPD in the UK, USA, or China. At 1,000 μg/d, we observed lower LAMA prescription for pMDI (adjusted odds ratio: 0.71; 95% confidence interval: 0.55, 0.91), but no difference in exacerbation rates, potentially due to higher dose of ICS overcoming low lung delivery from the DPI.
慢性阻塞性肺疾病(COPD)是一种复杂的进行性疾病,目前是全球第三大死因。一种推荐的治疗方案是吸入性糖皮质激素(ICS)/长效β受体激动剂的固定剂量联合疗法。临床试验表明,压力定量吸入器(pMDIs)和干粉吸入器(DPIs)在COPD治疗中显示出相似的疗效和安全性。现实世界的观察性研究表明,通过pMDIs进行联合治疗时,实现哮喘控制的几率显著更高。我们的目的是通过一项真实生活的历史匹配队列研究,比较COPD患者以两种剂量的丙酸氟替卡松(FP)(500和1000μg/天)通过pMDI与DPI起始使用丙酸氟替卡松(FP)/昔萘酸沙美特罗(SAL)治疗在中重度COPD加重和长效毒蕈碱拮抗剂(LAMA)处方方面的有效性。从最佳患者护理研究数据库中选取具有≥2年连续实践数据、通过pMDI/DPI开具≥2份FP/SAL处方且无ICS处方的COPD患者。患者按1:1进行匹配。分别使用条件泊松回归和逻辑回归分析中重度COPD加重率和LAMA处方几率。在472例每天使用500μg的患者中,我们观察到使用pMDI的患者(99例[42%])中重度加重的情况少于使用DPI的患者(115例[49%])(调整率比:0.71;95%置信区间:0.54,0.93),这是一个重要结果,因为pMDI在英国、美国或中国未获COPD治疗许可。在每天1000μg时,我们观察到pMDI的LAMA处方较低(调整优势比:0.71;95%置信区间:0.55,0.91),但加重率无差异,这可能是由于较高剂量的ICS克服了DPI肺部递送不足的问题。