PDF(Pubmed)
Abstract：
UNASSIGNED: Real-life research is needed to evaluate the effectiveness of budesonide/glycopyrrolate/formoterol (BGF) in routine COPD primary care management. We assessed the frequency of medication success among patients with COPD who initiated BGF using real-world data.
UNASSIGNED: Patients with a recorded diagnostic COPD code who started BGF with ≥2 prescriptions within 90-days were identified in the UK Optimum Patient Care Research Database and followed from first prescription until censoring at the end of follow-up (180-days), death, leaving database or end of data at 24/10/2022. The primary outcome was medication success at 90-days post-BGF initiation, defined as no major cardiac or respiratory event (ie no complicated COPD exacerbation, hospitalization for any respiratory event, myocardial infarction, new/hospitalized heart failure, and death) and no incidence of pneumonia. Medication success was also assessed at 180-days post-BGF initiation. Overall real-life medication success was claimed if the lower 95% confidence interval (CI) for the proportion of patients meeting the primary outcome was ≥70% (defined a priori).
UNASSIGNED: Two hundred eighty-five patients were included. Prior to BGF initiation, these patients often had severe airflow obstruction (mean ppFEV1: 54.5%), were highly symptomatic (mMRC ≥2: 77.9% (n = 205/263); mean CAT score: 21.7 (SD 7.8)), with evidence of short-acting β2-agonist (SABA) over-use (≥3 inhalers/year: 62.1%, n=179/285), repeat OCS prescriptions (≥2 courses/year: 33.0%, n = 95/285) and multiple primary care consultations (≥2 visits/year: 61.1%, n = 174/285). Overall, 39.6% of patients (n = 113/285) switched from previous triple therapies. Real-life medication success was achieved by 96.5% of patients (n = 275/285 [95% CI: 93.6, 98.3]) during 90-days treatment with BGF and by 91.8% (n = 169/184 [95% CI: 86.9, 95.4]) of patients at 180-days. The prescribed daily dose of SABA remained stable over the study period.
UNASSIGNED: The majority of patients initiating BGF experienced real-life medication success reflecting the absence of severe cardiopulmonary events. These benefits were apparent after 90-days of treatment and sustained over 180-days.
UNASSIGNED: Patients with a recorded diagnostic COPD code who started BGF with ≥2 prescriptions within 90-days were identified in the UK Optimum Patient Care Research Database and followed from first prescription until censoring at the end of follow-up (180-days), death, leaving database or end of data at 24/10/2022. The primary outcome was medication success at 90-days post-BGF initiation, defined as no major cardiac or respiratory event (ie no complicated COPD exacerbation, hospitalization for any respiratory event, myocardial infarction, new/hospitalized heart failure, and death) and no incidence of pneumonia. Medication success was also assessed at 180-days post-BGF initiation. Overall real-life medication success was claimed if the lower 95% confidence interval (CI) for the proportion of patients meeting the primary outcome was ≥70% (defined a priori).
UNASSIGNED: Two hundred eighty-five patients were included. Prior to BGF initiation, these patients often had severe airflow obstruction (mean ppFEV1: 54.5%), were highly symptomatic (mMRC ≥2: 77.9% (n = 205/263); mean CAT score: 21.7 (SD 7.8)), with evidence of short-acting β2-agonist (SABA) over-use (≥3 inhalers/year: 62.1%, n=179/285), repeat OCS prescriptions (≥2 courses/year: 33.0%, n = 95/285) and multiple primary care consultations (≥2 visits/year: 61.1%, n = 174/285). Overall, 39.6% of patients (n = 113/285) switched from previous triple therapies. Real-life medication success was achieved by 96.5% of patients (n = 275/285 [95% CI: 93.6, 98.3]) during 90-days treatment with BGF and by 91.8% (n = 169/184 [95% CI: 86.9, 95.4]) of patients at 180-days. The prescribed daily dose of SABA remained stable over the study period.
UNASSIGNED: The majority of patients initiating BGF experienced real-life medication success reflecting the absence of severe cardiopulmonary events. These benefits were apparent after 90-days of treatment and sustained over 180-days.
摘要：
■需要进行实际研究来评估布地奈德/格隆溴铵/福莫特罗（BGF）在常规COPD初级保健管理中的有效性。我们使用真实世界数据评估了开始使用BGF的COPD患者的药物成功频率。
■在UKOptimumPatientCareResearchDatabase中确定了记录有COPD诊断代码的患者，这些患者在90天内开始服用2次以上的BGF，并从第一次处方开始到随访结束时（180天）的审查，死亡,2022年10月24日离开数据库或数据结束。主要结果是BGF开始后90天的药物治疗成功，定义为无重大心脏或呼吸事件(即无复杂的COPD恶化，任何呼吸事件的住院治疗，心肌梗塞,新的/住院心力衰竭，和死亡），并且没有肺炎的发生率。还在BGF开始后180天评估药物治疗成功。如果满足主要结局的患者比例的较低的95％置信区间（CI）≥70％（先验定义），则声称实际用药的总体成功率。
■纳入了二百八十五名患者。在BGF开始之前，这些患者通常有严重的气流阻塞（平均ppFEV1：54.5%），有高度症状（mMRC≥2：77.9％（n=205/263）；平均CAT评分：21.7（SD7.8）），短效β2激动剂（SABA）过度使用的证据（≥3吸入器/年：62.1％，n=179/285)，重复OCS处方（≥2疗程/年：33.0%，n=95/285）和多次初级保健咨询（≥2次/年：61.1％，n=174/285）。总的来说,39.6％的患者（n=113/285）从以前的三联疗法转换。在使用BGF治疗90天期间，96.5％的患者（n=275/285[95％CI：93.6，98.3]）和91.8％的患者（n=169/184[95％CI：86.9，95.4]）在180天获得了现实生活中的药物治疗成功。SABA的规定每日剂量在研究期间保持稳定。
■大多数开始BGF的患者经历了现实生活中的药物治疗成功，反映了没有严重的心肺事件。这些益处在90天的治疗后是明显的并且持续超过180天。
■在UKOptimumPatientCareResearchDatabase中确定了记录有COPD诊断代码的患者，这些患者在90天内开始服用2次以上的BGF，并从第一次处方开始到随访结束时（180天）的审查，死亡,2022年10月24日离开数据库或数据结束。主要结果是BGF开始后90天的药物治疗成功，定义为无重大心脏或呼吸事件(即无复杂的COPD恶化，任何呼吸事件的住院治疗，心肌梗塞,新的/住院心力衰竭，和死亡），并且没有肺炎的发生率。还在BGF开始后180天评估药物治疗成功。如果满足主要结局的患者比例的较低的95％置信区间（CI）≥70％（先验定义），则声称实际用药的总体成功率。
■纳入了二百八十五名患者。在BGF开始之前，这些患者通常有严重的气流阻塞（平均ppFEV1：54.5%），有高度症状（mMRC≥2：77.9％（n=205/263）；平均CAT评分：21.7（SD7.8）），短效β2激动剂（SABA）过度使用的证据（≥3吸入器/年：62.1％，n=179/285)，重复OCS处方（≥2疗程/年：33.0%，n=95/285）和多次初级保健咨询（≥2次/年：61.1％，n=174/285）。总的来说,39.6％的患者（n=113/285）从以前的三联疗法转换。在使用BGF治疗90天期间，96.5％的患者（n=275/285[95％CI：93.6，98.3]）和91.8％的患者（n=169/184[95％CI：86.9，95.4]）在180天获得了现实生活中的药物治疗成功。SABA的规定每日剂量在研究期间保持稳定。
■大多数开始BGF的患者经历了现实生活中的药物治疗成功，反映了没有严重的心肺事件。这些益处在90天的治疗后是明显的并且持续超过180天。
